Impact of Implementing Preanalytical Laboratory Standards on the Diagnosis of Gestational Diabetes Mellitus: A Prospective Observational Study
Open accessAbstract
BACKGROUND: Gestational diabetes mellitus (GDM) is associated with adverse pregnancy outcomes, but risk is reduced with identification and early treatment. Glucose measurements are affected by preanalytical sample handling, such as temperature of storage, phlebotomy–analysis interval, and use of a glycolysis inhibitor. We evaluated glucose concentrations and the incidence of GDM after strict implementation of the American Diabetes Association (ADA) preanalytical guidelines, compared with usual hospital conditions. METHODS: Women screened selectively for GDM at 24–32 weeks' gestation were recruited at their convenience before a 75-g oral glucose tolerance test. Paired samples were taken: the first sample followed ADA recommendations and was transferred to the laboratory on an iced slurry for immediate separation and analysis (research conditions), and the second sample was not placed on ice and was transferred according to hospital practice (usual conditions). RESULTS: Of samples from 155 women, the mean fasting, 1-h, and 2-h results were 90.0 (12.6) mg/dL [5.0 (0.7) mmol/L], 142.2 (43.2) mg/dL [7.9 (2.4) mmol/L], and 102.6 (32.4) mg/dL [5.7 (1.8) mmol/L], respectively, under research conditions, and 81 (12.6) mg/dL [4.5 (0.7) mmol/L], 133.2 (41.4) mg/dL [7.4 (2.3) mmol/L], and 99 (32.4) mg/dL [5.5 (1.8) mmol/L] under usual conditions (all P < 0.0001). GDM was diagnosed in 38.1% (n = 59) under research conditions and 14.2% (n = 22) under usual conditions (P < 0.0001). The phlebotomy–analysis interval for the fasting, 1-h, and 2-h samples was 20 (9), 17 (10), and 17 (9) min under research conditions and 162 (19), 95 (23), and 32 (19) min under usual conditions (all P < 0.0001). All cases of GDM were diagnosed on fasting or 1-h samples; the 2-h test diagnosed no additional cases. CONCLUSIONS: Implementation of ADA preanalytical glucose sample handling recommendations resulted in higher mean glucose concentrations and 2.7-fold increased detection of GDM compared with usual hospital practices.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Comparison of glucose measured in samples collected in sodium fluoride-containing tubes kept in an ice-water slurry, as recommended, with those kept at room temperature increased the rate of diagnosis of GDM by 2.7-fold, entirely due to control of glycolysis.
“For example, comparison of glucose measured in samples collected in sodium fluoride-containing tubes kept in an ice-water slurry, as recommended (109), with those kept at room temperature increased the rate of diagnosis of GDM by 2.7-fold (277), entirely due to control of glycolysis.”
From Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus (2023) · cites this paper as [277]
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT
Martin Bland, J., & Altman, D. (1986) · The Lancet · doi:10.1016/s0140-6736(86)90837-8 · Cited by 47,965 · see citing works
Beckett, A. H., Rowland, M., & TURNER, P. (1965) · The Lancet · doi:10.1016/s0140-6736(65)91037-8 · Cited by 16,917 · see citing works
Hyperglycemia and adverse pregnancy outcomes
(2008) · New England Journal of Medicine · doi:10.1056/nejmoa0707943 · Cited by 5,563 · see citing works
International Association of Diabetes and Pregnancy Study Groups Consensus Panel (2010) · Diabetes Care · doi:10.2337/dc09-1848 · Cited by 5,390 · see citing works
Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes
Crowther, C. A., Hiller, J. E., Moss, J. R., McPhee, A. J., Jeffries, W. S., & Robinson, J. S. (2005) · New England Journal of Medicine · doi:10.1056/nejmoa042973 · Cited by 3,159 · see citing works
A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes
Landon, M. B., Spong, C. Y., Thom, E., Carpenter, M. W., Ramin, S. M., Casey, B., Wapner, R. J., Varner, M. W., Rouse, D. J., Thorp, J. M., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0902430 · Cited by 2,122 · cited 1× · see citing works
“The phlebotomy–analysis interval for the fasting, 1-h, and 2-h samples was 20 (9), 17 (10), and 17 (9) min under research conditions and 162 (19), 95 (23), and 32 (19) min under usual conditions (all P 0.”
MethodCriteria for screening tests for gestational diabetes
Carpenter, M. W., & Coustan, D. R. (1982) · American Journal of Obstetrics and Gynecology · doi:10.1016/0002-9378(82)90349-0 · Cited by 1,924 · see citing works
(1964) · PubMed · Cited by 1,230 · see citing works
Sacks, D. B., Arnold, M., Bakris, G. L., Bruns, D. E., Horvath, A. R., Kirkman, M. S., Lernmark, A., Metzger, B. E., & Nathan, D. M. (2011) · Diabetes Care · doi:10.2337/dc11-9998 · Cited by 718 · see citing works
Diagnostic Criteria and Classification of Hyperglycaemia First Detected in Pregnancy
Agarwal, M., Boulvain, M., Coetzee, E. J., Colagiuri, S., Falavigna, M., Hod, M., Meltzer, S. J., Metzger, B. E., Omori, Y., Rasa, I., et al. (2013) · Cited by 536 · see citing works
Buckley, B. S., Harreiter, J., Damm, P., Corcoy, R., Chico, A., Simmons, D., Vellinga, A., Dunne, F., & on behalf of the DALI Core Investigator Group (2012) · Diabetic Medicine · doi:10.1111/j.1464-5491.2011.03541.x · Cited by 360 · see citing works
Risk factors and obstetric complications associated with macrosomia
Stotland, N. E., Caughey, A. B., Breed, E. M., & Escobar, G. J. (2004) · International Journal of Gynecology & Obstetrics · doi:10.1016/j.ijgo.2004.08.010 · Cited by 301 · see citing works
Gestational Diabetes Mellitus: Clinical Predictors and Long-Term Risk of Developing Type 2 Diabetes
Lee, A. J., Hiscock, R., Wein, P., Walker, S., & Permezel, M. (2007) · Diabetes Care · doi:10.2337/dc06-1816 · Cited by 300 · see citing works
Effectiveness of sodium fluoride as a preservative of glucose in blood
Chan, A. Y., Swaminathan, R., & Cockram, C. S. (1989) · Clinical Chemistry · doi:10.1093/clinchem/35.2.315 · Cited by 289 · see citing works
The Pregnant Diabetic and Her Newborn. Problems and Management
(1968) · Archives of Disease in Childhood · doi:10.1136/adc.43.229.391-a · Cited by 224 · see citing works
Obesity and the White Blood Cell Count: Changes with Sustained Weight Loss
Dixon, J. B., & Brien, P. O. (2006) · Obesity Surgery · doi:10.1381/096089206776116453 · Cited by 164 · see citing works
Lehnen, H., Zechner, U., & Haaf, T. (2013) · Molecular Human Reproduction · doi:10.1093/molehr/gat020 · Cited by 141 · see citing works
Stabilization of glucose in blood samples: why it matters
Bruns, D. E., & Knowler, W. C. (2009) · Clinical Chemistry · doi:10.1373/clinchem.2009.126037 · Cited by 125 · see citing works
Reproducibility of the oral glucose tolerance test in pregnancy
Harlass, F. E., Brady, K., & Read, J. A. (1991) · American Journal of Obstetrics and Gynecology · doi:10.1016/s0002-9378(11)80021-9 · Cited by 84 · see citing works
Reproducibility of the oral glucose tolerance test in pregnant women
Catalano, P. M., Avallone, D. A., Drago, N. M., & Amini, S. B. (1993) · American Journal of Obstetrics and Gynecology · doi:10.1016/0002-9378(93)90019-f · Cited by 84 · see citing works
M. Stahl, L. G. M. J. (2001) · Scandinavian Journal of Clinical and Laboratory Investigation · doi:10.1080/003655101300133612 · Cited by 79 · see citing works
The influence of birth weight on labor in nulliparas.
Turner, M. J., Rasmussen, M., Turner, J., et al. (1990) · PubMed · Cited by 79 · see citing works
Self-citationDiagnosis of gestational diabetes mellitus: it is time for international consensus
Sacks, D. B. (2014) · Clinical Chemistry · doi:10.1373/clinchem.2013.206920 · Cited by 45 · see citing works
Citric/citrate buffer: an effective antiglycolytic agent
del Pino, I. G., Constanso, I. P., Mourín, L. V., Safont, C. B., & Vázquez, P. R. (2013) · Clinical Chemistry and Laboratory Medicine (CCLM) · doi:10.1515/cclm-2012-0735 · Cited by 33 · see citing works
Perspectives on the Proposed Gestational Diabetes Mellitus Diagnostic Criteria
Langer, O., Umans, J. G., & Miodovnik, M. (2012) · Obstetrics and Gynecology · doi:10.1097/aog.0b013e31827711e5 · Cited by 31 · see citing works
Daly, N., Stapleton, M., O’Kelly, R., Kinsley, B., Daly, S., & Turner, M. J. (2015) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2015.03.022 · Cited by 21 · see citing works
Self-citationClinical Laboratory Methods and Diagnosis
&NA; (1939) · Southern Medical Journal · doi:10.1097/00007611-193902000-00028 · Cited by 17 · see citing works
The impact of new national guidelines on screening for gestational diabetes mellitus.
Ali, F., Farah, N., O’Dwyer, V., O’Connor, C., Kennelly, M., & Turner, M. J. (2013) · PubMed · Cited by 16 · see citing works
Self-citationTime Is Glucose, Can't Miss Gestational Diabetes
Festa, R., Carta, M., Ceriello, A., & Testa, R. (2012) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2011.0225 · Cited by 6 · see citing works
Flagged first, then by citations
Research works printed but not linked: 1
- [9]9. http://www.ncbi.nlm.nih.gov/pubmed/24199271 (Accessed October 2014).
Cited by
Sorted by citations
Sacks, D. B., Arnold, M., Bakris, G. L., Bruns, D. E., Horvath, A. R., Lernmark, Å., Metzger, B. E., Nathan, D. M., & Kirkman, M. S. (2023) · Diabetes Care · doi:10.2337/dci23-0036 · Cited by 351 · see citing works
Maternal obesity and dyslipidemia associated with gestational diabetes mellitus (GDM)
O’Malley, E. G., Reynolds, C. M. E., Killalea, A., O’Kelly, R., Sheehan, S. R., & Turner, M. J. (2020) · European Journal of Obstetrics & Gynecology and Reproductive Biology · doi:10.1016/j.ejogrb.2020.01.007 · Cited by 62 · see citing works
Self-citationDiagnosis of gestational diabetes mellitus will be flawed until we can measure glucose
Bruns, D. E., Metzger, B. E., & Sacks, D. B. (2020) · Clinical Chemistry · doi:10.1093/clinchem/hvz027 · Cited by 30 · see citing works
Carey, R., Lunt, H., Heenan, H. F., Frampton, C. M. A., & Florkowski, C. M. (2016) · Clinical Biochemistry · doi:10.1016/j.clinbiochem.2016.05.017 · Cited by 26 · see citing works
Daly, N., Flynn, I., Carroll, C., Stapleton, M., O'Kelly, R., & Turner, M. J. (2016) · Clinical Chemistry · doi:10.1373/clinchem.2016.254466 · Cited by 19 · see citing works
Self-citation
- Authors
- Daly, N., Flynn, I., Carroll, C., Farren, M., McKeating, A., & Turner, M. J.
- Affiliations
- University College Dublin (IE)
- Corresponding author
- Daly, Niamh
- Venue
- Clinical Chemistry
- Publisher
- Oxford University Press (OUP)
- Published
- 2016-02-01
- Volume
- 62
- Issue
- 2
- Pages
- 387-391
- ISSN
- 0009-9147 (ISSN-L)
- 1530-8561
- OpenAlex
- W2255530717
- Semantic Scholar
- 80a4b3c217f78a49d758c0a57c3c85bcfe8bbd3f
- Cited by
- 50
- References
- 29
- Citations by year
- 2026: 4 · 2025: 1 · 2024: 2 · 2023: 5 · 2022: 3 · 2021: 3 · 2020: 10 · 2019: 6 · 2018: 1 · 2017: 6 · 2016: 8 · 2015: 1
- FWCI
- 3.93
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model (vor)
- Locations
- Clinical Chemistry (publishedVersion)
- PubMed (publishedVersion)
- Research Repository UCD (University College Dublin) (submittedVersion, cc-by-nc-nd)
- Topics
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal Health and Biochemistry
- Keywords
- gestational diabetes mellitus, pre-analytical variables, oral glucose tolerance test, sample storage temperature, glycolysis inhibitors, glucose measurement accuracy, GDM diagnosis, American Diabetes Association guidelines, laboratory quality improvement, adverse pregnancy outcomes, glycolysis inhibition
- MeSH terms
- Blood Specimen Collection, Female, Glucose Tolerance Test, Humans, Pregnancy, Prospective Studies, Diabetes, Gestational, Guidelines as Topic
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
