Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus

In the paper

“Decrease in glucose concentration in the sample due to glycolysis is a serious and underappreciated problem (62,63).”

What the sources say

• ?Not checked — no full text of the sourcecites [62] Bruns, 2020, Diagnosis of gestational diabetes mellitus will be flawed until we can measure glucose, Clin Chem source
• Supported

  In “Sources of Error in Measurements of Plasma Glucose,” the paper says glycolysis causes substantial glucose loss in blood samples, often exceeding laboratory analytical error. It also says sample handling has been little studied recently, perhaps because of a mistaken belief that sodium fluoride solved the problem. The “Diagnosis of Diabetes” section explains the serious consequence: patients may be misclassified. (LLM, conf=0.94)

  cites [63] Bruns, 2009, Stabilization of glucose in blood samples: why it matters, Clin Chem source

In the paper

“Many factors participate in the metabolic dysregulation that develops with increasing age, and changes in body composition make an important contribution (100).”

What the sources say

• Supported

  The ‘Mechanisms of Glucose Dysregulation’ section says that metabolic dysregulation in aging is multifaceted and that changes in body composition leading to insulin resistance play a major role. This directly supports the paraphrase. (LLM, conf=0.95)

  cites [100] Chia, 2018, Age-related changes in glucose metabolism, hyperglycemia, and cardiovascular risk, Circ Res source

In the paper

“FPG does not increase significantly after age 60, but 2-h glucose concentrations during a 75-g OGTT are considerably higher in older people (98,99).”

What the sources say

• Partly supported

  The Glucose homoeostasis section reports that glucose concentrations two hours after a 75-g oral glucose tolerance test gradually increase with age. It does not describe that increase as considerable; it also reports that fasting plasma glucose rises by approximately 0.055 mmol/L per decade, without stating that the rise becomes statistically insignificant after age 60. No page number is available in our copy. (LLM, conf=0.86)

  cites [98] van den Beld, 2018, The physiology of endocrine systems with ageing, Lancet Diabetes Endocrinol sourceExperimental — accuracy not yet measured
• ?Not checked — no full text of the sourcecites [99] Blunt, 1991, Evaluation of fasting plasma glucose as screening test for NIDDM in older adults. Rancho Bernardo Study, Diabetes Care source

In the paper

“The modeling demonstrated that increasing inaccuracy of the glucose measurements progressively increased (a) the number of severe hypoglycemic episodes over 30 days, (b) the total daily insulin use, and (c) the number of fingersticks per day.”

What the sources say

• Partly supported

  The Results sections report that higher measurement error is associated with more severe hypoglycemia, and that high error rates and positive bias increase daily insulin use and fingerstick counts. The study simulated 30 days, but Table 2 reports severe hypoglycemia as events per six months, not as a count over 30 days. Its results also depend on meter bias, so they do not establish an unqualified progressive increase for every meter. (LLM, conf=0.88)

  cites [127] Campos-Náñez, 2017, Clinical impact of blood glucose monitoring accuracy: an in-silico study, J Diabetes Sci Technol sourceExperimental — accuracy not yet measured

In the paper

“The second modeling study (128) demonstrated that meter inaccuracy increased the total cost of health care (including costs associated with hypoglycemic episodes), with the least accurate meters producing the greatest costs.”

What the sources say

• Supported

  The Methods (Analysis) describe a model estimating total additional cost from meter inaccuracy, including severe hypoglycemic events. The Results report higher additional costs for less accurate systems, and the Discussion states that systems failing the ISO 15197:2003 accuracy criteria had the highest costs. These are modeled costs for an in silico type 1 diabetes population. (LLM, conf=0.92)

  cites [128] Fortwaengler, 2018, The financial impact of inaccurate blood glucose monitoring systems, J Diabetes Sci Technol source

In the paper

“Most randomized controlled trials (RCTs) in adults with type 1 diabetes show that rt-CGM leads to lower HbA 1c (156-159) and reduced time in the hypoglycemic range (160,161).”

What the sources say

• ?Not checked — no full text of the sourcecites [156] Beck, 2017, Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the DIAMOND randomized clinical trial, JAMA source
• Partly supported

  The Introduction reports that participants randomized to CGM in the DIAMOND trial had larger A1C decreases and less time in hypoglycemic ranges than controls. This supports the outcomes for one trial, but the paper does not establish that most RCTs in adults with type 1 diabetes show both effects. (LLM, conf=0.86)

  cites [157] Riddlesworth, 2017, Hypoglycemic event frequency and the effect of continuous glucose monitoring in adults with type 1 diabetes using multiple daily insulin injections, Diabetes Ther sourceExperimental — accuracy not yet measured
• ?Not checked — no full text of the sourcecites [158] Lind, 2017, Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: the GOLD randomized clinical trial, JAMA source
• ?Not checked — no full text of the sourcecites [159] Tamborlane, 2008, Continuous glucose monitoring and intensive treatment of type 1 diabetes, N Engl J Med source
• Supported

  This citation is attached to reduced time in the hypoglycemic range, not to the HbA1c claim. The Results section reports that, in adults with type 1 diabetes, the duration of hypoglycemia was significantly lower during real-time CGM than during blinded CGM. Page numbers are not provided in our copy. (LLM, conf=0.92)

  cites [160] Hermanns, 2014, The impact of continuous glucose monitoring on low interstitial glucose values and low blood glucose values assessed by point-of-care blood glucose meters: results of a crossover trial, J Diabetes Sci Technol source
• ?Not checked — no full text of the sourcecites [161] van Beers, 2016, Continuous glucose monitoring for patients with type 1 diabetes and impaired awareness of hypoglycaemia (IN CONTROL): a randomised, open-label, crossover trial, Lancet Diabetes Endocrinol source

In the paper

“In a study of individuals under 18 years of age with type 1 diabetes, the frequency of BGM was found to correlate inversely with HbA 1c and with the incidence of diabetic ketoacidosis (151).”

What the sources say

• Supported

  The Patients and methods section describes a cohort of children and adolescents aged 0–18 years with type 1 diabetes. The Results report lower HbA1c with more frequent self-monitoring of blood glucose, though the association was weaker in younger children, and a significant inverse relationship between monitoring frequency and diabetic ketoacidosis. (LLM, conf=0.92)

  cites [151] Ziegler, 2011, Frequency of SMBG correlates with HbA1c and acute complications in children and adolescents with type 1 diabetes, Pediatr Diabetes source

In the paper

“Testing more frequently than 10 times per day was not associated with greater control of glycemia as HbA 1c levels were similar in participants testing 10 to 12 times per day and in those testing 13 or more times per day (7.8% and 7.7%, respectively).”

What the sources say

• Supported

  Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [150] Miller, 2013, Evidence of a strong association between frequency of self-monitoring of blood glucose and hemoglobin A1c levels in T1D exchange clinic registry participants, Diabetes Care source

In the paper

“A systematic review of RCTs in adults with type 1 or type 2 diabetes suggested that is-CGM may reduce HbA 1c in those with type 1 diabetes or insulin-treated type 2 diabetes (166), while another systematic review of studies (primarily in type 1 diabetes) with randomized or cohort designs suggested a small (0.26%) but statistically significant reduction in HbA 1c (167).”

What the sources say

• ?Not checked — no full text of the sourcecites [166] Cowart, 2020, Systematic review of randomized controlled trials evaluating glycemic efficacy and patient satisfaction of intermittent-scanned continuous glucose monitoring in patients with diabetes, Diabetes Technol Ther source
• Partly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [167] Castellana, 2020, Efficacy and safety of flash glucose monitoring in patients with type 1 and type 2 diabetes: a systematic review and meta-analysis, BMJ Open Diabetes Res Care sourceExperimental — accuracy not yet measured

In the paper

“Although most RCTs have not been powered to detect reductions in the rate of severe hypoglycemia, a study in people over the age of 60 with type 1 diabetes (a population at high risk of hypoglycemia) showed significant reductions in both time in the hypoglycemic range and severe hypoglycemic events (162).”

What the sources say

• Supported

  Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [162] Pratley, 2020, Effect of continuous glucose monitoring on hypoglycemia in older adults with type 1 diabetes: a randomized clinical trial, JAMA source

In the paper

“Many meters incorporate changes that eliminate or greatly ameliorate most interferences, but interferences persist (137,138).”

What the sources say

• Partly supported

  The Discussion describes newer meters with interference-detection and error-display functions, and the Conclusions report that interference-related errors still occur. The paper does not establish that many meters have such changes or that the changes eliminate or greatly ameliorate most interferences. (LLM, conf=0.85)

  cites [137] Sai, 2019, Evaluation of linearity and interference effect on SMBG and POCT devices, showing drastic high values, low values, or error messages, J Diabetes Sci Technol sourceExperimental — accuracy not yet measured
• ?Not checked — no full text of the sourcecites [138] Vanavanan, 2010, Performance of a new interference-resistant glucose meter, Clin Biochem source

In the paper

“Randomized controlled trials of the use of rt-CGM, compared with standard blood glucose monitoring, in adults with type 2 diabetes have generally shown reductions in HbA 1c with no significant change in time in hypoglycemia (169-172).”

What the sources say

• ?Not checked — no full text of the sourcecites [169] Yoo, 2008, Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes, Diabetes Res Clin Pract source
• ?Not checked — no full text of the sourcecites [170] Ehrhardt, 2011, The effect of real-time continuous glucose monitoring on glycemic control in patients with type 2 diabetes mellitus, J Diabetes Sci Technol source
• ?Not checked — no full text of the sourcecites [171] Beck, 2017, Continuous glucose monitoring versus usual care in patients with type 2 diabetes receiving multiple daily insulin injections: a randomized trial, Ann Intern Med source
• Partly supported

  The Primary and Key Secondary Outcomes section reports significantly lower HbA1c with CGM than with blood glucose meter monitoring in adults with type 2 diabetes treated with basal insulin. But the Other Glycemic Outcomes section reports exploratory reductions in time below both 54 mg/dL (P = .001) and 70 mg/dL (P = .02), rather than no significant change in time in hypoglycemia. This trial also cannot establish what trials generally found. (LLM, conf=0.91)

  cites [172] Martens, 2021, Effect of continuous glucose monitoring on glycemic control in patients with type 2 diabetes treated with basal insulin: a randomized clinical trial, JAMA sourceExperimental — accuracy not yet measured

In the paper

“Prevalence of undiagnosed diabetes is markedly increased in women aged 35 to 44 years, in those with race/ethnicity other than non-Hispanic White, and those with obesity (249).”

What the sources say

• Partly supported

  The Results (page not supplied) report higher prevalence of undiagnosed diabetes among women in the listed racial/ethnic groups and among women with obesity. They report higher prevalence of diabetes overall at ages 35–39 and 40–44, but do not establish that undiagnosed diabetes specifically was more prevalent at those ages. (LLM, conf=0.88)

  cites [249] Azeez, 2019, Hypertension and diabetes in non-pregnant women of reproductive age in the United States, Prev Chronic Dis sourceExperimental — accuracy not yet measured

In the paper

“One RCT of rt-CGM use during pregnancy in women with type 1 diabetes showed a modest but statistically significant reduction of HbA 1c in women randomized to rt-CGM compared with those randomized to continuing to use blood glucose meters, with no differences in severe hypoglycemia.”

What the sources say

• Supported

  Split into 2 atoms — 2 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [184] Feig, 2017, Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes (CONCEPTT): a multicentre international randomised controlled trial, Lancet source

In the paper

“One RCT of rt-CGM versus blood glucose monitoring in women with gestational diabetes mellitus showed no significant differences in HbA 1c or neonatal outcomes but less weight gain with CGM use (185).”

What the sources say

• Partly supported

  The Abstract and Results report an RCT in women with gestational diabetes: HbA1c and neonatal outcomes did not differ significantly, while the CGMS group gained significantly less weight. The Methods identify the device as a Gold Medtronic MiniMed CGMS but do not establish that the intervention was real-time CGM, so that specification is not supported by our copy. (LLM, conf=0.86)

  cites [185] Wei, 2016, Effect of a CGMS and SMBG on maternal and neonatal outcomes in gestational diabetes mellitus: a randomized controlled trial, Sci Rep sourceExperimental — accuracy not yet measured

In the paper

“However, the increasing accuracy of the devices and at least one RCT comparing nonadjunctive to adjunctive use (191) has led the FDA to approve most current CGM devices for nonadjunctive use in the U.S.”

What the sources say

• Supported

  The citation is attached to the claim that an RCT compared nonadjunctive with adjunctive CGM use. The Introduction describes that comparison, and the Conclusions report that CGM alone was noninferior to CGM with blood glucose monitoring. The subsequent statement about FDA approval of most current devices is not the part specifically attributed to this trial. (LLM, conf=0.94)

  cites [191] Aleppo, 2017, REPLACE-BG: a randomized trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in adults with well-controlled type 1 diabetes, Diabetes Care source

In the paper

“The accuracy of CGM devices has improved significantly over time, with manufacturers of current devices reporting mean absolute relative deviation (MARD) proportions of 8.1% to 12.3%, compared with 5% to 10% for current BGM devices (and 22% for the first intermittently read interstitial glucose monitor brought to market in 2001) (190).”

What the sources say

• Partly supported

  Section 2, “The Past: The ‘Smart’ CGM Sensor” (page unavailable), documents improved CGM accuracy, including a reduction in one device’s MARD from 13% to 9%. Section 3 says CGM accuracy became comparable to commercial SMBG devices. The text passages do not substantiate the claimed 8.1%–12.3% CGM range, 5%–10% BGM range, or 22% figure for a monitor introduced in 2001. (LLM, conf=0.88)

  cites [190] Facchinetti, 2016, Continuous glucose monitoring sensors: past, present and future algorithmic challenges, Sensors (Basel) sourceExperimental — accuracy not yet measured

In the paper

“Unfortunately, approximately 25% of those assigned to the 1-step group went through the 2-step process and the caregivers were not blinded to assignment of the participants.”

What the sources say

• Partly supported

  Methods (Randomization; page unavailable) states that providers could not be blinded, and Methods (Statistical Methods; page unavailable) says some participants assigned to 1-step screening received 2-step screening. Results (Trial Population; page unavailable) reports 66% adherence in the 1-step arm, but does not establish that approximately 25% specifically underwent 2-step screening. The paper describes a randomized trial, not a cohort study. (LLM, conf=0.86)

  cites [261] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med sourceExperimental — accuracy not yet measured

In the paper

“The HAPO FUS documented in both groups that risk of disorders of glucose metabolism at follow-up were associated with GDM and continuously with maternal glucose concentrations (268,269).”

What the sources say

• Partly supported

  The ‘Gestational Diabetes Status and Maternal Outcomes’ results report that disorders of glucose metabolism at follow-up were more frequent in mothers with gestational diabetes (52.2%) than in those without it (20.1%). This paper’s child outcomes concern adiposity, not disorders of glucose metabolism, and the passages do not establish a continuous association between maternal glucose concentrations and follow-up glucose disorders in both mothers and children. No page number is available in our copy. (LLM, conf=0.86)

  cites [268] Lowe, 2018, Association of gestational diabetes with maternal disorders of glucose metabolism and childhood adiposity, JAMA sourceExperimental — accuracy not yet measured
• Partly supported

  The Results (Association of Maternal GDM Status With Childhood Dichotomous Glucose Outcomes; page unavailable) report that maternal GDM was associated with impaired glucose tolerance in offspring aged 10–14, but not with impaired fasting glucose; type 2 diabetes cases were too few to analyze. This paper examines children, not outcomes in both mothers and children, and the passages found do not establish a continuous association between maternal glucose concentrations and follow-up disorders. (LLM, conf=0.86)

  cites [269] Lowe, 2019, Hyperglycemia and adverse pregnancy outcome follow-up study (HAPO FUS): maternal gestational diabetes mellitus and childhood glucose metabolism, Diabetes Care sourceExperimental — accuracy not yet measured

In the paper

“Although two RCTs found that treatment of GDM can reduce perinatal morbidity (264,265), it is not known whether treatment reduces long-term risks in children.”

What the sources say

• Supported

  The conclusions report that treatment of gestational diabetes reduces serious perinatal morbidity. The secondary-outcomes discussion says long-term follow-up is needed to determine whether treated children have fewer later complications. This paper is one of the two RCTs cited; it is not being cited as evidence that it conducted both trials. (LLM, conf=0.93)

  cites [264] Crowther, 2005, Effect of treatment of gestational diabetes mellitus on pregnancy outcomes, N Engl J Med source
• Supported

  The Discussion reports that this trial reduced shoulder dystocia and fetal overgrowth and says its findings were consistent with the ACHOIS trial. It also notes that treatment did not significantly reduce the composite primary perinatal outcome, so the support concerns specific complications rather than that composite. The citations are attached to the claim about the two RCTs, not the subsequent statement about long-term risks in children. (LLM, conf=0.90)

  cites [265] Landon, 2009, A multicenter, randomized trial of treatment for mild gestational diabetes, N Engl J Med source

In the paper

“Moreover, different glucose cutoffs for the 2-step screening were applied at the two sites.”

What the sources say

• Supported

  The Methods section (GDM Screening and Diagnosis Approaches) specifies different positive glucose challenge test cutoffs at the two sites: ≥130 mg/dL at Kaiser Permanente Northwest and ≥140 mg/dL at Kaiser Permanente Hawaii. The Discussion also identifies the differing thresholds as a limitation of the trial. (LLM, conf=0.95)

  cites [261] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med source

In the paper

“The frequency of GDM detected with the 1-step process was approximately twice that found with the 2-step process, but no significant differences in prespecified single or composite outcomes were found between the two groups.”

What the sources say

• Partly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [261] Hillier, 2021, A pragmatic, randomized clinical trial of gestational diabetes screening, N Engl J Med sourceExperimental — accuracy not yet measured

In the paper

“Frequently used is the colorimetric reaction that occurs between AcAc and nitroprusside (sodium nitroferricyanide), resulting in a purple color (301).”

What the sources say

• Supported

  The Discussion (section 7) says nitroprusside reacts with acetoacetate to change the test strip’s colour. The Introduction (section 1) identifies the nitroprusside test’s resulting colour as purple–violet. (LLM, conf=0.93)

  cites [301] Brooke, 2016, Evaluation of the accuracy of capillary hydroxybutyrate measurement compared with other measurements in the diagnosis of diabetic ketoacidosis: a systematic review, Int J Environ Res Public Health source

In the paper

“Blood ketone determinations that measure bOHB specifically are useful for both diagnosis (299,301) and ongoing monitoring of DKA (298,299).”

What the sources say

• Supported

  In “Blood Ketones for the Diagnosis and Management of DKA,” the paper reports that laboratory guidelines endorse blood BOHB measurement to diagnose and monitor DKA. The same section reports guidelines recommending repeated BOHB measurements to assess response to treatment. (LLM, conf=0.90)

  cites [299] Kilpatrick, 2022, Controversies around the measurement of blood ketones to diagnose and manage diabetic ketoacidosis, Diabetes Care source
• Supported

  The Introduction reports that blood β-OHB is recommended for diagnosis and treatment of ketoacidosis. The Conclusions support its diagnostic usefulness, while the Discussion explains that blood β-OHB falls as ketosis resolves and that urine ketones can misleadingly rise during treatment, supporting its usefulness for monitoring. The Discussion also cautions that point-of-care meters can be inaccurate at high β-OHB levels. (LLM, conf=0.86)

  cites [301] Brooke, 2016, Evaluation of the accuracy of capillary hydroxybutyrate measurement compared with other measurements in the diagnosis of diabetic ketoacidosis: a systematic review, Int J Environ Res Public Health source
• Supported

  The Diagnosis section recommends direct measurement of blood β-hydroxybutyrate to assess ketonaemia and says its measurement can guide response to DKA treatment. These passages support its use for both diagnosis and ongoing monitoring; page numbers were not supplied. (LLM, conf=0.94)

  cites [298] Dhatariya, 2020, Diabetic ketoacidosis, Nat Rev Dis Primers source

In the paper

“The presence of urine ketones is highly sensitive for DKA or significant ketosis, with high negative predictive value suggesting utility in ruling out DKA (300,301).”

What the sources say

• ?Not checked — no full text of the sourcecites [300] Schwab, 1999, Screening for ketonemia in patients with diabetes, Ann Emerg Med source
• Partly supported

  The Conclusions report high sensitivity for urine ketones in identifying DKA in the emergency department. But the Results report a urine-ketone negative predictive value of 71.84% in one study, and the Discussion notes DKA deaths in patients with negative urine-ketone tests. The source therefore does not support the claimed high negative predictive value or the suggested use of a negative test to rule out DKA. Page numbers are not available in our copy. (LLM, conf=0.88)

  cites [301] Brooke, 2016, Evaluation of the accuracy of capillary hydroxybutyrate measurement compared with other measurements in the diagnosis of diabetic ketoacidosis: a systematic review, Int J Environ Res Public Health sourceExperimental — accuracy not yet measured

In the paper

“In addition, due to its high specificity, urine glucose is advocated by the IDF as a screening test for undiagnosed diabetes in low-resource settings where other procedures are not available (297).”

What the sources say

• Partly supported

  The guideline’s screening discussion says urine glucose has high specificity (>98%) and may have a place for detecting undiagnosed diabetes in low-resource settings where other procedures are unavailable. But it also notes low sensitivity (21–64%); “may have a place” is more cautious than saying the IDF advocates it as a screening test. (LLM, conf=0.88)

  cites [297] International Diabetes Federation Guideline Development Group, 2014, Global guideline for type 2 diabetes, Diabetes Res Clin Pract sourceExperimental — accuracy not yet measured

In the paper

“The two major mechanisms responsible for the high ketone concentrations in people with diabetes are increased production from triglycerides and decreased utilization in the liver, both a result of absolute or relative insulin deficiency and increased counterregulatory hormones including cortisol, epinephrine, glucagon, and growth hormone (298).”

What the sources say

• Partly supported

  Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [298] Dhatariya, 2020, Diabetic ketoacidosis, Nat Rev Dis Primers sourceExperimental — accuracy not yet measured

In the paper

“Specifically, stringent control of HbA 1c values during pregnancy decreases congenital malformations, large-for-date infants, and the complications of pregnancy and delivery that can otherwise occur when glycemic control is not carefully managed (333).”

What the sources say

• Partly supported

  The Initial evaluation section links good glycemic control to fewer oversized infants and maternal, fetal, and neonatal complications. It places the risk of congenital malformations in the first few weeks of pregnancy and recommends achieving near-normal A1C before pregnancy to prevent them. The claim omits that timing distinction, implying that stringent control at any point during pregnancy reduces malformations. (LLM, conf=0.84)

  cites [333] Kitzmiller, 2008, Managing preexisting diabetes for pregnancy, Diabetes Care sourceExperimental — accuracy not yet measured

In the paper

“Analysis of 60 studies with 13 devices showed that most devices had negative bias (all the others had positive bias) and large standard deviations.”

What the sources say

• Supported

  The Results state that 60 studies analyzed mean bias for 13 devices; nine devices had negative mean bias and four had positive mean bias. The Clinical implications section describes the majority as having negative bias and large standard deviations. The Abstract gives a different study count (61), but the Results explicitly support the cited count of 60. (LLM, conf=0.91)

  cites [324] Hirst, 2017, Performance of point-of-care HbA1c test devices: implications for use in clinical practice—a systematic review and meta-analysis, Clin Chem Lab Med source

In the paper

“An HbA 1c value of 6.5% (48 mmol/mol) or greater is considered diagnostic.”

What the sources say

• Supported

  The Fasting and 2-Hour Plasma Glucose section identifies an A1C diagnostic threshold of ≥6.5% (48 mmol/mol). The Confirming the Diagnosis section adds that diagnosis generally requires two abnormal test results; the claim describes the threshold, not the full confirmation procedure. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source
• Supported

  The introduction states that 6.5% is the diagnostic HbA1c cut point, and the Methods (Diabetes Definitions) use ≥6.5% as the threshold for elevated HbA1c. The paper also notes that a diabetes diagnosis generally requires confirmatory testing; the threshold alone does not establish a confirmed diagnosis. (LLM, conf=0.88)

  cites [319] Selvin, 2018, Prognostic implications of single-sample confirmatory testing for undiagnosed diabetes: a prospective cohort study, Ann Intern Med source

In the paper

“The role of HbA 1c in the diagnosis of diabetes was first proposed and implemented in 2009 ( 22), made possible by improved assay standardization through the NGSP (National Glycohemoglobin Standardization Program) and IFCC, and new data demonstrating the association between HbA 1c concentrations and risk for retinopathy (22).”

What the sources say

• Partly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [22] International Expert Committee, 2009, International Expert Committee report on the role of the A1c assay in the diagnosis of diabetes, Diabetes Care sourceExperimental — accuracy not yet measured

In the paper

“However, the comparator was conversion when urine ketones were negative, which is not a typical marker for resolution (308).”

What the sources say

• Partly supported

  The Abstract identifies the comparator as the study’s current end-point B, but it required both pH above 7.3 and ketone-free urine—not negative urine ketones alone. The Discussion supports the qualification that negative urine ketones are not a generally required marker for transition: it says guidelines allow urinary ketones to remain present and that practice varies between centres. (LLM, conf=0.86)

  cites [308] Noyes, 2007, Hydroxybutyrate near-patient testing to evaluate a new end-point for intravenous insulin therapy in the treatment of diabetic ketoacidosis in children, Pediatr Diabetes sourceExperimental — accuracy not yet measured

In the paper

“HbA 1c is used as an index of mean glycemia, as a measure of risk for the development of diabetes complications, and, most importantly, to set goals of therapy for people with diabetes (295,318,327).”

What the sources say

• Supported

  The Glycated hemoglobin testing section says GHb is used as an index of mean glycemia and a measure of risk for diabetes complications. The Standardization of GHb section says the DCCT established specific diabetes treatment goals using GHb as an index of mean blood glucose; the paper also identifies HbA1c as a form of GHb. (LLM, conf=0.94)

  cites [295] Goldstein, 2004, Tests of glycemia in diabetes, Diabetes Care source
• Supported

  The A1C Measurement section says A1C represents average glucose over the preceding 8–12 weeks and predicts the risk of microvascular complications. The Perspective section says it is routinely used to monitor glycemic control and guide therapy, supporting its use in setting treatment goals. (LLM, conf=0.93)

  cites [318] Sacks, 2011, A1c versus glucose testing: a comparison, Diabetes Care source
• Not checked yetcites [327] American Diabetes Association, 2000, Implications of the diabetes control and complications trial, Diabetes Care

In the paper

“In addition, a study among races showed that all measures of glycemia, including HbA 1c , fructosamine, and glycated albumin, were on average higher among Black participants compared with White participants, and that the measures were similarly associated with risk of nephropathy, retinopathy, and cardiovascular disease (CVD) in the different races (340).”

What the sources say

• Partly supported

  Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [340] Parrinello, 2016, Racial differences in and prognostic value of biomarkers of hyperglycemia, Diabetes Care sourceExperimental — accuracy not yet measured

In the paper

“One study has suggested that differences in mean red cell half-life, which may range from approximately 48 to 68 days (mean 58 days and 1 SD of 4.5 to 6.5 days), may explain some of the interindividual variability in the relationship between measured average glucose and HbA 1c levels (343).”

What the sources say

• Supported

  The section “Measured variation in MRBC is sufficient to explain all non-glycemic variation in HbA1c” (page unavailable) reports a mean red-cell age of about 58 days with a standard deviation of 4.5–6.5 days. It also finds that variation in mean red-cell age could explain the observed glucose-independent variation in HbA1c, supporting the citing sentence’s hedged conclusion. The approximately 48–68-day range is a rough inference from the reported mean and variability, rather than a range stated verbatim. (LLM, conf=0.87)

  cites [343] Malka, 2016, Mechanistic modeling of hemoglobin glycation and red blood cell kinetics enables personalized diabetes monitoring, Sci Transl Med source

In the paper

“The NGSP reference method, which was the DCCT primary reference, is a cation-exchange HPLC method that quantifies HbA 1c and is a CLSI-designated comparison method (360).”

What the sources say

• Partly supported

  The Materials and Methods section (REFERENCE METHOD AT THE BHL; page not provided) describes the DCCT reference method as an ion-exchange HPLC assay that quantifies HbA1c. The paper also describes the BHL’s role in NGSP network monitoring, but the passages do not establish that CLSI designated the method a comparison method. (LLM, conf=0.86)

  cites [360] Steffes, 2005, Hemoglobin A1c measurements over nearly two decades: sustaining comparable values throughout the Diabetes Control and Complications Trial and the Epidemiology of Diabetes Interventions and Complications study, Clin Chem sourceExperimental — accuracy not yet measured

In the paper

“Since 1996, the NGSP, initiated under the auspices of the AACC and endorsed by the ADA, has standardized GHb test results among laboratories to DCCT-equivalent HbA 1c values (357-359) and focused on improving worldwide assay performance.”

What the sources say

• Supported

  The Introduction states that the NGSP was established in 1996 to make routine HbA1c results traceable to DCCT results. The NGSP Process describes calibration to NGSP/DCCT results, while The NGSP Network says it certifies manufacturers and laboratories worldwide; Status of HbA1c Measurement identifies improved assay accuracy as an NGSP objective. (LLM, conf=0.92)

  cites [357] Little, 2019, The national glycohemoglobin standardization program: over 20 years of improving hemoglobin A1c measurement, Clin Chem source
• Not checked yetcites [358] Little, 2001, The national glycohemoglobin standardization program: a five-year progress report, Clin Chem
• Not checked yetcites [359] Goldstein, 1997, Bringing order to chaos: the National Glycohemoglobin Standardization Program, Contemp Intern Med

In the paper

“Most methods can be classified into groups based on assay principle (66,295,312).”

What the sources say

• Not checked yetcites [66] Rifai, 2017, Carbohydrates
• Supported

  The “Chemistry and terminology” section states that glycated-hemoglobin assay methods can be divided into two major categories according to their assay principles: charge differences or structural characteristics. It also says most methods quantify HbA1c. (LLM, conf=0.94)

  cites [295] Goldstein, 2004, Tests of glycemia in diabetes, Diabetes Care source
• Not checked yetcites [312] Goldstein, 1986, Glycated hemoglobin: methodologies and clinical applications, Clin Chem

In the paper

“These additional genetic factors may assist in assigning a probability of the diagnosis of type 1 diabetes of uncertain etiology, and genetic risk scores for type 1 diabetes have been developed (390).”

What the sources say

• Partly supported

  The First Paragraph says genetic factors have been used in type 1 diabetes prediction and that combined risk factors improve the accuracy of diagnoses in adult incident cases. Extended Data Fig. 2 also describes several genetic risk scores. The paper does not show that these scores assign a probability of type 1 diabetes as the diagnosis when a patient's diabetes etiology is uncertain; its individual probability estimates concern future disease risk in children. (LLM, conf=0.83)

  cites [390] Ferrat, 2020, A combined risk score enhances prediction of type 1 diabetes among susceptible children, Nat Med sourceExperimental — accuracy not yet measured

In the paper

“However, an exception is the mutational analyses established for classification of diabetes in the neonate (381-384) as well as in young individuals with a dominant family history of diabetes, often referred to as maturityonset diabetes of the young (MODY) (384,385) (Table 8).”

What the sources say

• Supported

  The Study population section (page unavailable) describes mutation screening in patients with neonatal diabetes and in families meeting MODY criteria, including affected members across generations. The Conclusions (page unavailable) recommend INS mutation screening for diabetes diagnosed before age one and identify INS mutations as a cause of both permanent neonatal diabetes and MODY. (LLM, conf=0.88)

  cites [381] Edghill, 2008, Insulin mutation screening in 1,044 patients with diabetes: mutations in the INS gene are a common cause of neonatal diabetes but a rare cause of diabetes diagnosed in childhood or adulthood, Diabetes source
• Partly supported

  The Conclusions state that testing for genetic defects in neonatal diabetes is critical for guiding management, and the Results report genetic diagnoses in 20 of 32 patients diagnosed before six months of age. The paper describes a family with MODY-type diabetes in the Discussion (Variable phenotype), but does not establish mutational analysis as a classification method for young people with a dominant family history of diabetes. Page numbers are unavailable in our copy. (LLM, conf=0.86)

  cites [382] Støy, 2008, Diagnosis and treatment of neonatal diabetes: a United States experience, Pediatr Diabetes sourceExperimental — accuracy not yet measured
• ?Not checked — no full text of the sourcecites [383] Murphy, 2008, Clinical implications of a molecular genetic classification of monogenic beta-cell diabetes, Nat Clin Pract Endocrinol Metab source
• Supported

  The Introduction describes MODY as dominantly inherited diabetes typically diagnosed young. The Clinical Characteristics and Details of Testing sections describe molecular genetic testing to identify and diagnose MODY. This source is cited for the MODY portion of the sentence, not the neonatal-diabetes portion. (LLM, conf=0.91)

  cites [384] Carlsson, 2020, Absence of islet autoantibodies and modestly raised glucose values at diabetes diagnosis should lead to testing for MODY: lessons from a 5-year pediatric Swedish National Cohort Study, Diabetes Care source
• ?Not checked — no full text of the sourcecites [385] Fajans, 2001, Molecular mechanisms and clinical pathophysiology of maturity-onset diabetes of the young, N Engl J Med source

In the paper

“Up to 90% of individuals with type 1 diabetes diagnosed before age 30 years have the HLA haplotypes DRB1*04-DQA1*03:01-DQB1* 03:02(DR4-DQ8), DRB1*03-DQA1*05:01-DQB1*02:01 (DR3-DQ2.5),or both (379).”

What the sources say

• Partly supported

  The Discussion (page not available in our copy) discusses DQ2 and DQ8 haplotypes in patients with type 1 diabetes and relates their disease risk to age at onset. It does not report that up to 90% of people diagnosed before age 30 carry either specified DR–DQ haplotype, or both; that prevalence and age cutoff are unsupported. (LLM, conf=0.82)

  cites [379] Graham, 2002, Genetic effects on age-dependent onset and islet cell autoantibody markers in type 1 diabetes, Diabetes sourceExperimental — accuracy not yet measured

In the paper

“Although several islet autoantibodies have been detected in individuals with type 1 diabetes, and these have prognostic value in individuals at high risk of type 1 diabetes, routine measurement of islet autoantibodies has limited use outside of clinical studies (410).”

What the sources say

• Partly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  cites [410] Warshauer, 2020, New frontiers in the treatment of type 1 diabetes, Cell Metab sourceExperimental — accuracy not yet measured

In the paper

“In children with only one persistent islet autoantibody, the risk of diabetes within 10 years is 15% while two or more islet autoantibodies predict type 1 diabetes in 70% within 10 years (408,409).”

What the sources say

• Supported

  The Results report 10-year progression of 14.5% for children with a single islet autoantibody and 69.7% for those with multiple autoantibodies, matching the rounded figures in the claim. The Methods define seroconversion using positive serial samples, supporting the claim’s reference to persistent autoantibodies. Page numbers are unavailable in our copy. (LLM, conf=0.94)

  cites [408] Ziegler, 2013, Seroconversion to multiple islet autoantibodies and risk of progression to diabetes in children, JAMA source
• Partly supported

  The Results (page unavailable) report that children who developed a second autoantibody had a higher risk of type 1 diabetes than those who remained positive for one. The Conclusions (page unavailable) likewise describe multiple autoantibodies as conferring higher risk. Neither passage gives the claimed 10-year risks of 15% and 70%; the figure caption instead identifies a five-year comparison. (LLM, conf=0.87)

  cites [409] Vehik, 2020, Hierarchical order of distinct autoantibody spreading and progression to type 1 diabetes in the TEDDY study, Diabetes Care sourceExperimental — accuracy not yet measured

In the paper

“There is some evidence that early diagnosis may prevent hospitalization with ketoacidosis and preserve residual b-cells (393).”

What the sources say

• Partly supported

  The Onset hospitalization section (page not provided) reports far fewer hospitalizations among closely followed DAISY children than community cases, and the discussion describes decreased hospitalization for DKA at onset. The Insulin dose section reports lower insulin requirements after diagnosis, but the paper does not establish that early diagnosis preserves residual beta cells. (LLM, conf=0.84)

  cites [393] Barker, 2004, Clinical characteristics of children diagnosed with type 1 diabetes through intensive screening and follow-up, Diabetes Care sourceExperimental — accuracy not yet measured

In the paper

“Depending on the specific MODY mutation, the disease can be mild (e.g., glucokinase mutation) and not usually associated with long term complications of diabetes or as severe as typical type 1 diabetes (e.g., hepatocyte nuclear factor [HNF] mutations) (2).”

What the sources say

• Supported

  The Maturity-Onset Diabetes of the Young section describes GCK-MODY as mild and stable. The Diagnosis of Monogenic Diabetes section reports no complications for GCK-MODY in studies without glucose-lowering therapy, while complication risks for HNF1A- and HNF4A-MODY are similar to those in type 1 and type 2 diabetes. (LLM, conf=0.92)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“Type 2 diabetes is a heterogenous polygenic disease with both resistance to the action of insulin and defective insulin secretion (4,5).”

What the sources say

• ?Not checked — no full text of the sourcecites [4] Reaven, 1988, Banting lecture 1988. Role of insulin resistance in human disease, Diabetes source
• Supported

  The Summary describes type II diabetes as a polygenic, heterogeneous disease involving defects in both insulin action and insulin secretion. The Review Article passage identifies decreased insulin action in peripheral tissues as insulin resistance and describes impaired insulin production as the other major defect. (LLM, conf=0.95)

  cites [5] Sacks, 1996, The pathogenesis of type II diabetes mellitus. A polygenic disease, Am J Clin Pathol source

In the paper

“However, the risk alleles in these loci all have relatively small effects and do not significantly enhance our ability to predict the risk of type 2 diabetes (396,397).”

What the sources say

• ?Could not verify

  The Discussion (page unavailable) reports smaller eQTL effects for variants in certain islet regulatory regions, but those are effects on gene expression, not estimates of how much the alleles change diabetes risk. The Introduction and Results (pages unavailable) discuss risk variants and their mechanisms; searches for risk-effect sizes and predictive ability found no passage assessing either part of the claim. (LLM, conf=0.74)

  cites [396] Viñuela, 2020, Genetic variant effects on gene expression in human pancreatic islets and their implications for T2D, Nat Commun sourceExperimental — accuracy not yet measured
• Partly supported

  The Discussion reports small individual per-allele effects and says the 18-allele score did not substantially improve prediction beyond common phenotypic risk factors measured in adulthood. The claim omits that condition: the paper also reports modest discriminatory ability when only factors known in youth were considered. (LLM, conf=0.86)

  cites [397] Meigs, 2008, Genotype score in addition to common risk factors for prediction of type 2 diabetes, N Engl J Med sourceExperimental — accuracy not yet measured

In the paper

“Genome-wide association studies have identified more than 30 genetic factors, which increase the risk for type 2 diabetes (394,395).”

What the sources say

• Supported

  The opening section reports that GWAS had identified more than 120 loci influencing type 2 diabetes risk. The Results section (“Discovery of novel loci for T2D susceptibility”) reports 243 loci associated with type 2 diabetes at genome-wide significance, supporting the claim that more than 30 genetic factors had been identified. (LLM, conf=0.94)

  cites [394] Mahajan, 2018, Fine-mapping type 2 diabetes loci to single-variant resolution using high-density imputation and islet-specific epigenome maps, Nat Genet source
• ?Not checked — no full text of the sourcecites [395] Mansour Aly, 2021, Genome-wide association analyses highlight etiological differences underlying newly defined subtypes of diabetes, Nat Genet source

In the paper

“ICA tests measure the degree of binding of immunoglobulin to islet sections and are compared with a WHO standard serum available from the National Institute of Biological Standards and Control (437).”

What the sources say

• Supported

  The paper describes ICA detection by immunofluorescence binding on human pancreatic tissue sections and reports assay results relative to the proposed standard serum 97/550 (Abstract; Results). It identifies 97/550 as the WHO international standard for ICA and says the ampouled serum would be distributed by NIBSC after approval; the Discussion reports that approval was granted. (LLM, conf=0.90)

  cites [437] Mire-Sluis, 2000, The World Health Organization International Collaborative Study for islet cell antibodies, Diabetologia source

In the paper

“Most individuals without diabetes who have only one autoantibody will not develop type 1 diabetes, as the 10-year risk is about 15% (408).”

What the sources say

• Partly supported

  The Results section, “Children With a Single Islet Autoantibody,” reports a 14.5% risk of progression to diabetes within 10 years, supporting the approximate 15% figure and the statement that most did not progress. The study measured this risk in children, however, while the citing sentence extends it to individuals generally. (LLM, conf=0.86)

  cites [408] Ziegler, 2013, Seroconversion to multiple islet autoantibodies and risk of progression to diabetes in children, JAMA sourceExperimental — accuracy not yet measured

In the paper

“Diabetes is associated with a high rate of cardiovascular events and is also the leading cause of end-stage renal disease in the Western world (452).”

What the sources say

• Partly supported

  In the Introduction’s section on geographic variation in treated ESKD incidence (page unavailable), the review identifies diabetes as a risk factor associated with kidney disease in high-income countries, including the US and Europe. It does not say diabetes is the leading cause of end-stage kidney disease in the Western world. (LLM, conf=0.78)

  cites [452] Thurlow, 2021, Global epidemiology of end-stage kidney disease and disparities in kidney replacement therapy, Am J Nephrol sourceExperimental — accuracy not yet measured

In the paper

“Diabetes is associated with a high rate of cardiovascular events and is also the leading cause of end-stage renal disease in the Western world (452).”

What the sources say

• ?Could not verify

  The section on ESKD incidence in the United States discusses diabetes as a contributor to kidney-disease burden, while the section on KRT access lists diabetes and cardiovascular disease separately. Neither passage addresses whether people with diabetes have a high rate of cardiovascular events (searched: “diabetes cardiovascular events” and “cardiovascular”). (LLM, conf=0.77)

  cites [452] Thurlow, 2021, Global epidemiology of end-stage kidney disease and disparities in kidney replacement therapy, Am J Nephrol sourceExperimental — accuracy not yet measured

In the paper

“Moderately increased albuminuria without hypertension indicates increased relative risk of CKD progression, but absolute risks of end-stage kidney disease are higher with concomitant hypertension (485-487).”

What the sources say

• ?Not checked — no full text of the sourcecites [485] Weir, 2010, Editorial perspective. Should microalbuminuria ever be considered as a renal endpoint in any clinical trial?, Am J Nephrol source
• ?Not checked — no full text of the sourcecites [486] Mok, 2021, Albuminuria and prognosis among individuals with atherosclerotic cardiovascular disease: the ARIC study, J Am Coll Cardiol source
• ?Could not verify

  The Introduction and Conclusions examine albuminuria as a predictor of cardiovascular outcomes after myocardial infarction, not CKD progression or end-stage kidney disease. Searches for relative and absolute kidney-disease risks with and without hypertension found only a related reference title, not a passage stating the claimed comparison. (LLM, conf=0.75)

  cites [487] Mok, 2019, Albuminuria as a predictor of cardiovascular outcomes in patients with acute myocardial infarction, J Am Heart Assoc sourceExperimental — accuracy not yet measured

In the paper

“The authors concluded that calibration bias was the main source of error for differences among methods and precision was adequate for most assays.”

What the sources say

• Supported

  The Discussion (page not provided) identifies bias as the dominant source of disagreement among routine methods and calls for standardized calibration traceability. It also says imprecision was generally good, with combined CVs below 10% except for five procedures. (LLM, conf=0.92)

  cites [498] Bachmann, 2014, State of the art for measurement of urine albumin: comparison of routine measurement procedures to isotope dilution tandem mass spectrometry, Clin Chem source

In the paper

“Screening using two tests with either being positive interpreted as a positive (leading to subsequent quantitative testing) increases the sensitivity to 97% but reduces the specificity to 83% (500,501).”

What the sources say

• ?Not checked — no full text of the sourcecites [500] McTaggart, 2014, Diagnostic accuracy of point-of-care tests for detecting albuminuria: a systematic review and meta-analysis, Ann Intern Med source
• ?Could not verify

  The Results section on ACR testing rates reports how often patients were tested, and the Methods section describes repeat ACR measurements. Neither evaluates a two-test screening rule in which either positive result triggers quantitative testing, or reports 97% sensitivity and 83% specificity. Searches for those figures and the two-test rule found no supporting passage in our copy; page numbers were not available. (LLM, conf=0.76)

  cites [501] Shin, 2021, Albuminuria testing in hypertension and diabetes: an individual-participant data meta-analysis in a global consortium, Hypertension sourceExperimental — accuracy not yet measured

In the paper

“Moreover, the authors point out that it can minimize the testing time and inconvenience and significantly reduce national health costs (503).”

What the sources say

• Supported

  The Introduction (page unavailable) describes the quantitative test as time-consuming and requiring transport to a central laboratory, while presenting the semiquantitative test as a point-of-care alternative. The Discussion calls the semiquantitative method convenient, and Results Table 4 estimates a 23.8% cost saving for the modeled 10-year screening strategy in Korea. (LLM, conf=0.91)

  cites [503] Kim, 2020, Can a semi-quantitative method replace the current quantitative method for the annual screening of microalbuminuria in patients with diabetes? Diagnostic accuracy and cost-saving analysis considering the potential health burden, PLoS One source

In the paper

“In the KDIGO and ADA algorithms for urine albumin testing (506), the diagnosis of moderately increased or severely increased albuminuria requires the demonstration of increased albumin excretion on two of three tests repeated at intervals over a period of 3 to 6 months and exclusion of conditions that invalidate the test.”

What the sources say

• ?Could not verify

  Split into 2 atoms — 0 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 2 unverifiable. Expand the claim to see per-atom verdicts.

  cites [506] American Diabetes Association Professional Practice Committee, 2021, 12. Retinopathy, neuropathy, and foot care: Standards of Medical Care in Diabetes—2022, Diabetes Care sourceExperimental — accuracy not yet measured

In the paper

“The authors concluded that a negative semiquantitative POC test result does not rule out albuminuria, whereas quantitative POC testing meets required performance standards and can be used to rule out albuminuria.”

What the sources say

• ?Could not verify

  The Introduction (page unavailable) mentions routine urine dipstick testing, but does not evaluate negative semiquantitative results. The Discussion (page unavailable) concerns ACR screening rates, not point-of-care test accuracy. Searches for semiquantitative and quantitative POC testing found no passage addressing rule-out performance or required standards. (LLM, conf=0.76)

  cites [501] Shin, 2021, Albuminuria testing in hypertension and diabetes: an individual-participant data meta-analysis in a global consortium, Hypertension sourceExperimental — accuracy not yet measured

In the paper

“The most reliable method is the immunoturbidimetric laboratory assay, which should be considered the standard for comparison as it has >95% sensitivity and specificity to detect moderately increased albuminuria (505).”

What the sources say

• Partly supported

  The Materials and Methods (IMMUNOASSAY; page unavailable) identify immunoturbidimetry as the laboratory’s routine clinical urine-albumin assay. But the Results (METHOD COMPARISON; page unavailable) report that it underestimated albumin with the supplied calibrators, and the paper gives no >95% diagnostic sensitivity or specificity for detecting moderately increased albuminuria. It does not establish immunoturbidimetry as the most reliable method or the standard for comparison. (LLM, conf=0.88)

  cites [505] Shaikh, 2008, Comparison between immunoturbidimetry, size-exclusion chromatography, and LC-MS to quantify urinary albumin, Clin Chem sourceExperimental — accuracy not yet measured

In the paper

“Sensitivity and specificity estimates for the quantitative test were 96% (95% CI, 78-99%) and 98% (95% CI, 93-99%), respectively.”

What the sources say

• ?Could not verify

  The Methods (Outcomes and Statistical Analyses) and Results (ACR Testing Rate and Prevalence of ACR ≥30 mg/g) describe albumin-to-creatinine ratio testing rates and albuminuria prevalence, not the diagnostic accuracy of a quantitative point-of-care test. Searches for the quantitative test, sensitivity, specificity, and the stated confidence intervals found no passage supporting the 96% and 98% estimates. Page numbers were not available in our copy. (LLM, conf=0.76)

  cites [501] Shin, 2021, Albuminuria testing in hypertension and diabetes: an individual-participant data meta-analysis in a global consortium, Hypertension sourceExperimental — accuracy not yet measured

In the paper

“and that measures of insulin resistance (which include insulin measurements) predicted risk of diabetes or CAD only moderately, with no threshold effects (509).”

What the sources say

• Partly supported

  The Conclusions report modest predictive performance and no apparent threshold effects for surrogate measures of insulin resistance. However, the paper assesses diabetes and cardiovascular disease (CVD), not coronary artery disease (CAD) separately; the DM and CVD Assessment section defines CVD to include noncoronary events such as stroke and heart failure. (LLM, conf=0.86)

  cites [509] Rutter, 2008, Use of alternative thresholds defining insulin resistance to predict incident type 2 diabetes mellitus and cardiovascular disease, Circulation sourceExperimental — accuracy not yet measured

In the paper

“Stakeholders in the U.S., Japan, and elsewhere have worked on developing a reference standard and traceability schemes, but there is a need for further coordination to assure worldwide harmonization of C-peptide (516).”

What the sources say

• Supported

  The Conclusions say that lack of coordination can hinder global harmonization and that better communication and coordination are important. The Summary describes C-peptide standardization efforts in the US, Japan, and elsewhere, along with a proposed traceability scheme. (LLM, conf=0.94)

  cites [516] Little, 2017, Implementing a reference measurement system for C-peptide: successes and lessons learned, Clin Chem source

In the paper

“The pooled sensitivity and specificity at each cutoff point were the following: uACR >30 mg/g, 0.82 (95% CI, 0.76-0.87)and 0.88 (95% CI, 0.83-0.91);uACR 30 to 300 mg/g, 0.72 (95% CI, 0.68-0.77)and 0.82 (95% CI, 0.76-0.89);and uACR >300 mg/g, 0.84 (95% CI, 0.71-0.90)and 0.97 (95% CI, 0.95-0.99),respectively.”

What the sources say

• Partly supported

  The Results of meta-analyses and Summary of findings report all six pooled sensitivity and specificity estimates at the stated ACR cutoffs. However, the citing sentence gives two confidence-interval bounds that differ from those sections: specificity at 30–300 mg/g ends at 0.89 rather than 0.86, and sensitivity at >300 mg/g begins at 0.71 rather than 0.74. Those bounds do appear in the paper’s Abstract, so the paper is internally inconsistent on them. (LLM, conf=0.84)

  cites [502] Mejia, 2021, Diagnostic accuracy of urine dipstick testing for albumin-to-creatinine ratio and albuminuria: a systematic review and meta-analysis, Heliyon sourceExperimental — accuracy not yet measured

In the paper

“HNF1B-MODY”

What the sources say

• Supported

  Table 2.6 (shown under Future Considerations; page not provided) lists HNF1B as the gene for HNF1B-MODY. The Maturity-Onset Diabetes of the Young section also discusses HNF1B mutations or deletions in this context. (LLM, conf=0.93)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“ABCC8 | AD”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists ABCC8 under neonatal diabetes with inheritance marked “AD.” The table defines AD as autosomal dominant. (LLM, conf=0.95)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“HNF1B | AD”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists HNF1B with inheritance marked “AD,” meaning autosomal dominant. The Maturity-Onset Diabetes of the Young section also describes MODY inheritance as autosomal dominant. (LLM, conf=0.95)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“KCNJ11 | AD”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists KCNJ11 under neonatal diabetes with inheritance marked “AD,” and the table defines AD as autosomal dominant. The Neonatal Diabetes section also describes permanent neonatal diabetes caused by KCNJ11 mutations as autosomal dominant. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“atrophy of the pancreas”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists “atrophy of the pancreas” among the clinical features of HNF1B-MODY. (LLM, conf=0.95)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“This clinical situation is quite rare and usually occurs in individuals with insulin-treated type 2 diabetes”

What the sources say

• Partly supported

  The Introduction describes sporadic reports of high-titre insulin antibodies, and the ‘Increased insulin resistance and risk of hyperglycaemia’ section associates high titres with insulin resistance. The Conclusion recommends investigating insulin-treated type 2 patients with unexplained glucose problems, but the paper does not establish that this situation usually occurs in type 2 rather than type 1 diabetes. (LLM, conf=0.84)

  cites [519] Hu, 2018, Exogenous insulin antibody syndrome (EIAS): a clinical syndrome associated with insulin antibodies induced by exogenous insulin in diabetic patients, Endocr Connect sourceExperimental — accuracy not yet measured

In the paper

“hyperuricemia”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists hyperuricemia among the clinical features of HNF1B-MODY. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“INS | AD”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists INS under neonatal diabetes with inheritance marked “AD,” which the table defines as autosomal dominant. The Neonatal Diabetes section also says most diabetes-causing INS mutations are dominantly inherited. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“autoimmune diabetes”

What the sources say

• Supported

  The FOXP3 row of the table in Future Considerations explicitly lists autoimmune diabetes as a feature of IPEX syndrome. The Diagnosis section also associates IPEX with type 1 diabetes. (LLM, conf=0.95)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“EIF2B1 | AD”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists EIF2B1 with an inheritance designation of “AD.” The table defines AD as autosomal dominant. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“epiphyseal dysplasia”

What the sources say

• Supported

  The table in Future Considerations explicitly lists “Wolcott-Rallison syndrome: epiphyseal dysplasia” under EIF2AK3-associated permanent diabetes. This directly supports the attributed characterization. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“mechanisms include UPD6”

What the sources say

• Supported

  Table 2.6 (Future Considerations; page not provided) lists 6q24 neonatal diabetes as transient and explicitly names UPD6, paternal duplication, and maternal methylation defect as mechanisms. Its footnote defines UPD6 as uniparental disomy of chromosome 6. (LLM, conf=0.95)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“immunodysregulation”

What the sources say

• Supported

  The Diagnosis section spells out IPEX as immune dysregulation, polyendocrinopathy, enteropathy, and X-linked syndrome. The FOXP3 entry in the Future Considerations table repeats those characteristics. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“GATA6 | AD”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists GATA6 under the Gene column and “AD” under Inheritance. The table defines AD as autosomal dominant. (LLM, conf=0.95)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“FOXP3 | X-linked”

What the sources say

• Supported

  The table of common causes of monogenic diabetes (Future Considerations, Table 2.6) lists FOXP3 with an inheritance pattern of “X-linked.” The Diagnosis section also identifies IPEX as an X-linked disorder caused by FOXP3 mutation. (LLM, conf=0.95)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“EIF2AK3 | AR”

What the sources say

• Supported

  Table 2.6 (Future Considerations) lists EIF2AK3 with inheritance marked “AR” and defines “AR” as autosomal recessive. (LLM, conf=0.95)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“autoimmune thyroid disease”

What the sources say

• Supported

  The table in Future Considerations lists autoimmune thyroid disease among the conditions associated with FOXP3-related IPEX syndrome. This directly supports the attributed characterization. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“exfoliative”

What the sources say

• Supported

  The Future Considerations table lists exfoliative dermatitis among the features of IPEX syndrome. This directly supports the attributed claim. (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“insulin requiring”

What the sources say

• Supported

  Table 2.6 in Future Considerations lists FOXP3-associated IPEX syndrome and describes its diabetes as “insulin requiring.” (LLM, conf=0.94)

  cites [2] American Diabetes Association Professional Practice Committee, 2021, 2. Classification and diagnosis of diabetes: Standards of Care in Diabetes—2022, Diabetes Care source

In the paper

“Issues of concern remain (a) overmodeling of the calibration data, (b) uncontrolled variations associated with skin, and (c) poor specificity for indirect methods.”

In the paper

“The resulting calibration models cannot measure glucose concentrations accurately during subsequent OGTTs, thereby severely limiting clinical utility.”

In the paper

“However, Heise and coworkers provide a complete analysis of these measurements and conclude that direct measurement of glucose is not possible at the measured wavelength bands and that the system, as described, lacks the ability to produce stable calibration functions required for practical clinical operation (240).”

What the sources say

• ?Not checked — no full text of the sourcecites [240] Vahlsing, 2018, Noninvasive monitoring of blood glucose using color-coded photoplethysmographic images of the illuminated fingertip within the visible and near-infrared range: opportunities and questions, J Diabetes Sci Technol source

In the paper

“For example, the HbA 1c concentration at the first prenatal visit identifies risk of adverse pregnancy outcomes and diabetes during pregnancy but is less effective for ascertainment of GDM (285,286).”

What the sources say

• ?Not checked — no full text of the sourcecites [285] Mañé, 2017, Role of first-trimester Hb1c as a predictor of adverse obstetric outcomes in a multiethnic cohort, J Clin Endocrinol Metab source
• ?Not checked — no full text of the sourcecites [286] Fong, 2014, Use of hemoglobin A1c as an early predictor of gestational diabetes mellitus, Am J Obstet Gynecol source

In the paper

“Although urine glucose is detectable in individuals with grossly increased blood glucose concentrations, it provides no information about blood glucose concentrations below the variable renal glucose threshold (approximately 10 mmol/L [180 mg/dL]).”

In the paper

“Compared with testing urine ketones, children with type 1 diabetes (and caregivers) were more likely to measure blood ketones during periods of illness, and those randomized to blood ketone testing had almost half the number of emergency department visits or hospitalizations (302).”

What the sources say

• ?Not checked — no full text of the sourcecites [302] Laffel, 2006, Sick day management using blood 3-hydroxybutyrate (3-OHB) compared with urine ketone monitoring reduces hospital visits in young people with T1DM: a randomized clinical trial, Diabet Med source

In the paper

“Furthermore, the extent of renal concentration of the urine will affect urine glucose concentrations and only average glucose values between voidings are reflected, further minimizing the value of urine glucose determinations.”

In the paper

“The average yield is 30 to 40 mg DNA from 1 mL of whole blood.”

In the paper

“Diabetes can be diagnosed by demonstrating increased concentrations of glucose in venous plasma or increased hemoglobin A 1c (HbA 1c ) in the blood.”

In the paper

“(c) symptoms of diabetes and a casual (i.e., regardless of the time of the preceding meal) plasma glucose $11.1 mmol/L (200 mg/dL)”

What the sources say

• ?Not checked — no full text of the sourcecites [18] The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, 1997, Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, Diabetes Care source

In the paper

“Global estimates are that approximately 50% of people with diabetes are undiagnosed (7).”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites [7] International Diabetes Federation . IDF Diabetes Atlas. 10th ed.2021. Accessed 23 May 2022. Available from https://diabetesatlas.org/idfawp/resource-files/2021/07/IDF_Atlas_10th_Edition_2021.pdf

In the paper

“The revised criteria comprised (a) fasting plasma glucose (FPG) $7.0 mmol/L (126 mg/dL)”

What the sources say

• ?Not checked — no full text of the sourcecites [18] The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, 1997, Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus, Diabetes Care source

In the paper

“A short turnaround time for glucose analysis is not usually necessary for the diagnosis of diabetes.”

In the paper

“Therapy in participants with type 2 diabetes in the UKPDS (52) was adjusted according to FPG concentrations-BGM was not utilized.”

What the sources say

• ?Not checked — no full text of the sourcecites [52] UK Prospective Diabetes Study (UKPDS) Group, 1998, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33), Lancet source

In the paper

“A very few laboratories (<1%) use glucose dehydrogenase.”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites [85] Sacks, 2023, Carbohydrates

In the paper

“Using biological variation as the basis for deriving analytical performance characteristics (87), the following desirable specifications for glucose have been proposed (95,96): analytical imprecision #2.4%, bias #2.1%, and total error #6.1%.”

What the sources say

• ?Not checked — no full text of the sourcecites [87] Fraser, 1999, Analytical performance characteristics should be judged against objective quality specifications, Clin Chem source
• ?Not checked — no full text of the sourcecites [95] Aarsand, 2018, The EuBIVAS: within- and between-subject biological variation data for electrolytes, lipids, urea, uric acid, total protein, total bilirubin, direct bilirubin, and glucose, Clin Chem source
• ?Not checked — no full text of the sourcecites [96] González-Lao, 2019, Systematic review of the biological variation data for diabetes related analytes, Clin Chim Acta source

In the paper

“However, this value is based on suggestions of clinicians and no outcome data have been published that validate this figure.”

In the paper

“No consensus has been achieved on the analytic goals for glucose analysis, although numerous criteria have been proposed.”

What the sources say

• ?Not checked — no full text of the sourcecites [87] Fraser, 1999, Analytical performance characteristics should be judged against objective quality specifications, Clin Chem source

In the paper

“Intensive glycemic control can decrease microvascular complications as shown by the DCCT for individuals with type 1 (50) diabetes and by the UKPDS for type 2 (52) diabetes.”

What the sources say

• ?Not checked — no full text of the sourcecites [50] Nathan, 1993, The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus, N Engl J Med source
• ?Not checked — no full text of the sourcecites [52] UK Prospective Diabetes Study (UKPDS) Group, 1998, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33), Lancet source

In the paper

“Reference intervals in children are 3.3 to 5.6 mmol/L (60 to 100 mg/dL), similar to the adult range of 4.1 to 5.5 mmol/L (74 to 99 mg/dL) (66).”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites [66] Rifai, 2017, Carbohydrates

In the paper

“Thus, the biological variability within an individual is substantially greater than analytic variability; analytic imprecision makes a negligible contribution to variation in patient results.”

In the paper

“BGM and CGM can be useful for detecting asymptomatic hypoglycemia and allowing people to avoid severe hypoglycemic episodes, especially when insulin is used in treatment.”

In the paper

“Analytical bias and/or imprecision at low concentrations can lead to frequent false alarms of neonatal hypoglycemia or missed cases of true hypoglycemia (134).”

What the sources say

• ?Not checked — no full text of the sourcecites [134] Inman, 2021, Contribution of glucose meter error to misclassification of neonatal glycemic status, JAMA Pediatr source

In the paper

“Frequent use of BGM (or CGM) is particularly important for tight glycemic control and avoidance of frequent hypoglycemia in type 1 diabetes.”

In the paper

“The risk of hypoglycemia is seen primarily in individuals treated with insulin or insulin secretagogues, and risk increases significantly when pharmacologic therapy is directed toward maintaining glucose concentrations close to those found in individuals without diabetes (52).”

What the sources say

• ?Not checked — no full text of the sourcecites [52] UK Prospective Diabetes Study (UKPDS) Group, 1998, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33), Lancet source

In the paper

“Recurrent education at clinic visits and comparison of BGM with concurrent laboratory glucose analysis have been shown to improve the accuracy of BGM (116).”

What the sources say

• ?Not checked — no full text of the sourcecites [116] Kabadi, 1994, The effect of recurrent practice at home on the acceptability of capillary blood glucose readings. Accuracy of self blood glucose testing, Diabetes Care source

In the paper

“Furthermore, many individuals with diabetes, particularly those with type 1, lose the autonomic warning symptoms that normally precede neuroglycopenia (”

What the sources say

• ?Not checked — no full text of the sourcecites [108] Gerich, 1991, Hypoglycemia unawareness, Endocr Rev source

In the paper

“High hematocrit will increase or decrease the measured glucose, or will have minimal effect, depending on the design of the measuring system (132,133).”

What the sources say

• ?Not checked — no full text of the sourcecites [132] Warner, 2011, Can one point-of-care glucose meter be used for all pediatric and adult hospital patients? Evaluation of three meters, including recently modified test strips, Diabetes Technol Ther source
• ?Not checked — no full text of the sourcecites [133] Ceriotti, 2015, Comparative performance assessment of point-of-care testing devices for measuring glucose and ketones at the patient bedside, J Diabetes Sci Technol source

In the paper

“The incidence of major hypoglycemic episodes-requiring third-party help or medical interventionwas two-to threefold higher in the intensive group than in the conventional group in clinical trials of participants with type 1 and type 2 diabetes, with the absolute rate far higher in type 1 diabetes than in type 2 (52).”

What the sources say

• ?Not checked — no full text of the sourcecites [52] UK Prospective Diabetes Study (UKPDS) Group, 1998, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33), Lancet source

In the paper

“Hypoglycemia is a major risk in treatment of diabetes, and BGM or CGM may help to detect and avoid this potentially life-threatening complication.”

In the paper

“Hematocrit affects the glucose results of some meters, with falsely high glucose results at low hematocrits and falsely low results at high hematocrits (143,144).”

What the sources say

• ?Not checked — no full text of the sourcecites [143] Wada, 2015, Evaluation of two glucose meters and interference corrections for screening neonatal hypoglycemia, Pediatr Int source
• ?Not checked — no full text of the sourcecites [144] Demircik, 2015, Evaluation of hematocrit interference with MyStar extra and seven competitive devices, J Diabetes Sci Technol source

In the paper

“In a large trial of rt-CGM in people with type 1 diabetes showing significant reductions in HbA 1c in adults (159), improved glucose control was not seen in children (ages 8 to 14 years) or adolescents and young adults (ages 15 to 24 years).”

What the sources say

• ?Not checked — no full text of the sourcecites [159] Tamborlane, 2008, Continuous glucose monitoring and intensive treatment of type 1 diabetes, N Engl J Med source

In the paper

“One RCT showed less time in the hypoglycemic range, without significant change in HbA 1c (163).”

What the sources say

• ?Not checked — no full text of the sourcecites [163] Bolinder, 2016, Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial, Lancet source

In the paper

“Professional CGM, along with professional interpretation, patient education, and therapy adjustments, may help reduce hyper-and/or hypoglycemia, but rigorous data are lacking (105).”

What the sources say

• ?Not checked — no full text of the sourcecites [105] American Diabetes Association Professional Practice Committee, 2021, 7. Diabetes technology: Standards of Medical Care in Diabetes—2022, Diabetes Care source

In the paper

“However, with increasing prevalence of undiagnosed type 2 diabetes in women of childbearing age, the definition changed to exclude diabetes found (by standard nonpregnancy criteria) at an early prenatal visit.”

In the paper

“A few years later a two-step approach was advocated, in which a screening 50-g glucose challenge test was introduced to rule out women who would not need a full OGTT; only women who failed the screening test went on to an OGTT (250).”

What the sources say

• ?Not checked — no full text of the sourcecites [250] Committee on Practice Bulletins—Obstetrics, 2018, ACOG Practice Bulletin No. 190: gestational diabetes mellitus, Obstet Gynecol source

In the paper

“Using the IADPSG criteria substantially increases the incidence of GDM, mainly because only one increased glucose value is required to diagnose GDM rather than two.”

What the sources say

• ?Not checked — no full text of the sourcecites [258] Metzger, 2010, International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy, Diabetes Care source

In the paper

“The original O'Sullivan and Mahan diagnostic criteria were based on blood glucose values in a 3-h 100-g OGTT predictive of later risk of diabetes mellitus in the women (252).”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites [252] O’Sullivan, 1964, Criteria for the oral glucose tolerance test in pregnancy, Diabetes

In the paper

“In 2013 a National Institutes of Health (NIH) Consensus Development Conference Statement recommended that the two-step approach for detection and diagnosis of GDM, predominately used in the U.S., should continue to be used rather than the 1-step approach and criteria proposed by IADPSG (253,254).”

What the sources say

• Not checked yetcites [253] Vandorsten, 2013, NIH consensus development conference: diagnosing gestational diabetes mellitus, NIH Consens State Sci Statements
• ?Not checked — no full text of the sourcecites [254] Anonymous, 2013, NIH consensus development conference statement: diagnosing gestational diabetes mellitus, March 4-6, 2013, Obstet Gynecol source

In the paper

“In 2014 the ADA acknowledged that consensus had not been reached concerning detection and diagnosis of GDM and endorsed the use of either the 1-step or the 2-step approach (260).”

What the sources say

• ?Not checked — no full text of the sourcecites [260] American Diabetes Association, 2014, Standards of medical care in diabetes—2014, Diabetes Care source

In the paper

“The diagnostic thresholds for GDM, especially for FPG, are substantially lower than those for diabetes i.e., 92 mg/dL (5.1 mmol/L) or 95 mg/dL (5.3 mmol/L) by IADPSG or Carpenter-Coustan criteria, respectively (Table 7).”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites Table 7

In the paper

“Insulinindependent glucose uptake by the fetus and placenta leads to lower fasting glucose values, while diabetogenic placental hormones produce postprandial hyperglycemia and carbohydrate intolerance.”

In the paper

“Notwithstanding these limitations, urine glucose monitoring is supported by the IDF in situations where blood glucose monitoring is not accessible or affordable, particularly in resource-poor settings (296).”

What the sources say

• ?Not checked — no full text of the sourcecites [296] IDF Clinical Guidelines Task Force, 2006, Global guideline for type 2 diabetes: recommendations for standard, comprehensive, and minimal care, Diabet Med source

In the paper

“Commercially available strips use the glucose oxidase reaction (89).”

What the sources say

• ?Not checked — no full text of the sourcecites [89] Fraser, 1990, The necessity of achieving good laboratory performance, Diabet Med source

In the paper

“Based on analysis of OGTT results from the Danish Odense Cohort Study (289,290), McIntyre et al. (289) have questioned the universal use of the value $92 mg/dL (5.1 mmol/L) as the FPG threshold for a diagnosis of GDM by the IADPSG (258) and WHO (259) criteria for GDM.”

What the sources say

• ?Not checked — no full text of the sourcecites [289] McIntyre, 2018, Gestational diabetes mellitus: does one size fit all? A challenge to uniform worldwide diagnostic thresholds, Diabetes Care source
• ?Not checked — no full text of the sourcecites [290] Kyhl, 2015, The Odense Child Cohort: aims, design, and cohort profile, Paediatr Perinat Epidemiol source
• ?Not checked — no full text of the sourcecites [258] Metzger, 2010, International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy, Diabetes Care source
• ?Not checked — no full text of the sourcecites [259] Colagiuri, 2014, Strategies for implementing the WHO diagnostic criteria and classification of hyperglycaemia first detected in pregnancy, Diabetes Res Clin Pract source

In the paper

“In contrast to POCT, laboratories that measure HbA 1c need to have a CLIA certificate, be inspected, and meet the CLIA quality standards (326).”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites [326] U.S. Centers for Medicare & Medicaid Services . CLIA brochures. Accessed 26 August 2022. Available from https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures

In the paper

“These standards include specified personnel requirements (including documented annual competency assessments) and participation three times per year in an approved proficiency testing program.”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites [326] U.S. Centers for Medicare & Medicaid Services . CLIA brochures. Accessed 26 August 2022. Available from https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/CLIA_Brochures

In the paper

“Intraindividual CVs in healthy people are very small (<2%), and many current assay methods can achieve intralaboratory CVs <1.5% and interlaboratory CVs <2.0% among different laboratories using the same method (366).”

What the sources say

• ?Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  cites [366] Sacks, 2020

In the paper

“Analysis is performed by cleaving hemoglobin with endoproteinase Glu-C and separating the resulting glycated and nonglycated N-terminal b-chain hexapeptides by HPLC (363).”

What the sources say

• ?Not checked — no full text of the sourcecites [363] Hoelzel, 2004, IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden: a method-comparison study, Clin Chem source

In the paper

“These haplotypes are common in the general population and confer increased risk but are not causative for type 1 diabetes.”

In the paper

“As noted above, the NGSP has largely succeeded in standardizing the GHb assay across methods and laboratories.”

In the paper

“Furthermore, the IFCC reference method, which provides reference materials for manufacturers, is being implemented worldwide.”

In the paper

“However, HLA typing is useful for clinical research studies, either in subjects followed from birth or children identified by autoantibody screening of relatives of individuals with type 1 diabetes.”

In the paper

“This material is formed rapidly with hyperglycemia and could interfere with some HbA 1c assay methods if not completely removed or separated.”

What the sources say

• ?Not checked — no full text of the sourcecites [368] Goldstein, 1980, Effects of acute changes in blood glucose on HbA1c, Diabetes source

In the paper

“Therefore, HLA molecules are genetic etiological factors in the initiation phase of autoimmune diabetes but not during pathogenesis.”

In the paper

“Four major genetic forms of MODY have been identified (Table 8) and individuals at risk within MODY pedigrees can be identified through genetic means.”

In the paper

“People at the highest genetic risk of type 1 diabetes are those in whom all four DQ combinations meet this criterion.”

In the paper

“HLA-DQ genes appear to be central to the HLA-associated risk of type 1 diabetes, albeit DR genes may be independently involved.”

In the paper

“Blood samples should be drawn into test tubes containing EDTA and the DNA preparations should be harvested within 3 days; longer periods both lower the yield and degrade the quality of the DNA obtained.”

In the paper

“There are over 60 distinct genetic disorders associated with glucose intolerance or frank diabetes.”

In the paper

“DNA samples are best kept at À80 C in Tris-EDTA solution, where the integrity of the sample lasts virtually indefinitely.”

In the paper

“The islet autoantibodies are directed against insulin (IAA), GAD65 (GADA), insulinoma-associated antigen 2 (IA-2A), or zinc transporter 8 (ZnT8A) and predict type 1 diabetes.”