Practical classification guidelines for diabetes in patients treated with insulin: a cross-sectional study of the accuracy of diabetes diagnosis
Open accessAbstract
BACKGROUND: Differentiating between type 1 and type 2 diabetes is fundamental to ensuring appropriate management of patients, but can be challenging, especially when treating with insulin. The 2010 UK Practical Classification Guidelines for Diabetes were developed to help make the differentiation. AIM: To assess diagnostic accuracy of the UK guidelines against 'gold standard' definitions of type 1 and type 2 diabetes based on measured C-peptide levels. DESIGN AND SETTING: In total, 601 adults with insulin-treated diabetes and diabetes duration ≥5 years were recruited in Devon, Northamptonshire, and Leicestershire. METHOD: Baseline information and home urine sample were collected. Urinary C-peptide creatinine ratio (UCPCR) measures endogenous insulin production. Gold standard type 1 diabetes was defined as continuous insulin treatment within 3 years of diagnosis and absolute insulin deficiency (UCPCR<0.2 nmol/mmol ≥5 years post-diagnosis); all others classed as having type 2 diabetes. Diagnostic performance of the clinical criteria was assessed and other criteria explored using receiver operating characteristic (ROC) curves. RESULTS: UK guidelines correctly classified 86% of participants. Most misclassifications occurred in patients classed as having type 1 diabetes who had significant endogenous insulin levels (57 out of 601; 9%); most in those diagnosed ≥35 years and treated with insulin from diagnosis, where 37 out of 66 (56%) were misclassified. Time to insulin and age at diagnosis performed best in predicting long-term endogenous insulin production (ROC AUC = 0.904 and 0.871); BMI was a less strong predictor of diabetes type (AUC = 0.824). CONCLUSION: Current UK guidelines provide a pragmatic clinical approach to classification reflecting long-term endogenous insulin production; caution is needed in older patients commencing insulin from diagnosis, where misclassification rates are increased.
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Adults with type 1 diabetes may retain sufficient β-cell function to prevent DKA for many years; such individuals may have remission or decreased insulin needs for months or years, eventually become dependent on insulin for survival, and are at risk for DKA.
“Adults may retain suf fi cient b -cell function to prevent DKA for many years; such individuals may have remission or decreased insulin needs for months or years, eventually become dependent on insulin for survival, and are at risk for DKA (33 -35,60,61).”
From 2. Diagnosis and Classification of Diabetes: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [35]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredThe onset of type 1 diabetes may be more variable in adults; they may not present with the classic symptoms seen in children and may experience temporary remission from the need for anticipated full-dose insulin replacement.
“The onset of type 1 diabetes may be more variable in adults; they may not present with the classic symptoms seen in children and may experience temporary remission from the need for anticipated full-dose insulin replacement (33 -35).”
From 2. Diagnosis and Classification of Diabetes: <i>Standards of Care in Diabetes—2024</i> (2024) · cites this paper as [35]
The Discussion (Implications for research and practice; page unavailable) describes adults with latent autoimmune diabetes who may not need insulin for at least six months, supporting a variable course of insulin need. It does not discuss whether adults lack the classic symptoms seen in children or experience a temporary remission after needing full-dose insulin replacement. (LLM, conf=0.85)
Experimental — accuracy not yet measuredAdults may retain sufficient b-cell function to prevent DKA for many years; such individuals may have remission characterized by decreased insulin needs for months or years, eventually become dependent on insulin for survival, and are at risk for DKA.
“Adults may retain sufficient b-cell function to prevent DKA for many years; such individuals may have remission characterized by decreased insulin needs for months or years, eventually become dependent on insulin for survival, and are at risk for DKA (33-35, 59,60).”
From 2. Diagnosis and classification of diabetes: standards of care in diabetes-2025 (2025) · cites this paper as [35]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredRapid progression to insulin treatment (<3 years) is strongly suggestive of type 1 diabetes at any age.
“Rapid progression to insulin treatment (<3 years) is strongly suggestive of type 1 diabetes at any age (6,8,15).”
From The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021) · cites this paper as [8]
The Results (Optimal clinical criteria; page not available) identify time from diagnosis to insulin as the strongest individual discriminator, supporting the link between rapid insulin treatment and type 1 diabetes. But the optimal cut-off was 12 months, not three years. The Discussion (Implications for research and practice; page not available) also reports substantial misclassification among people diagnosed at age 35 or older and treated with insulin from diagnosis, so the unqualified claim that this is strongly suggestive at any age is not supported. (LLM, conf=0.88)
Experimental — accuracy not yet measuredApproximately 5-10% of White European people with new-onset type 1 diabetes have negative islet antibodies.
“The absence of autoantibodies does not exclude type 1 diabetes, since approximately 5-10% of White European people with new-onset type 1 diabetes have negative islet antibodies (8,9,25), and further consideration of the diagnosis is necessary.”
From The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021) · cites this paper as [8]
The Results describe white European patients who had diabetes for at least five years, not people with new-onset diabetes. The Discussion (Implications for research and practice) proposes studies using islet antibodies at diagnosis, but gives no estimate of how often people with new-onset type 1 diabetes test negative. Searches for antibody-negative cases and the 5–10% figure found no supporting passage in our copy. (LLM, conf=0.75)
Experimental — accuracy not yet measured
The absence of autoantibodies does not exclude type 1 diabetes.
“The absence of autoantibodies does not exclude type 1 diabetes, since approximately 5-10% of White European people with new-onset type 1 diabetes have negative islet antibodies (8,9,25), and further consideration of the diagnosis is necessary.”
From The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2021) · cites this paper as [8]
The Introduction and Abstract Method define type 1 diabetes using insulin deficiency and treatment history, but do not report whether patients lacked autoantibodies. The Discussion (Implications for research and practice; page unavailable) proposes studying islet antibodies to improve diagnosis, without saying whether a negative result excludes type 1 diabetes. Searches for antibody-negative type 1 diabetes and antibody-test sensitivity found no passage addressing the claim. (LLM, conf=0.72)
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The challenge of diagnosing type 1 diabetes in older adults
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Self-citationReclassification of type 2 diabetes to type 1 diabetes in Asturias (Spain) between 2011 and 2020
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GADA persistence and diabetes classification
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Self-citationClinical features of childhood diabetes mellitus focusing on latent autoimmune diabetes
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β-Cell mass versus function in type 1 diabetes mellitus: truth or dare?
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Predictive Modeling for Diabetes Subtype Classification in India: A Machine Learning Approach
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Simultaneous Pancreas and Kidney Transplantation in Patients With Type 2 Diabetes Mellitus
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Metabolic Disorders and Management of High-Risk Patients
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Self-citationZinc transporter 8 antibody-mediated type 1 diabetes mellitus
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Self-citation
- Authors
- Hope, S. V., Wienand-Barnett, S., Shepherd, M., King, S. M., Fox, C., Khunti, K., Oram, R. A., Knight, B. A., Hattersley, A. T., Jones, A. G., & Shields, B. M.
- Affiliations
- National Institute of Health Researches of Iran (IR)
- Northampton General Hospital (GB)
- University of Leicester (GB)
- University of Exeter (GB)
- ORCID
- Venue
- British Journal of General Practice
- Published
- 2016-04-14
- Volume
- 66
- Issue
- 646
- Pages
- e315-e322
- ISSN
- 0960-1643 (ISSN-L)
- 1478-5242
- PMC
- PMC4838443
- OpenAlex
- W2336113197
- Cited by
- 87
- References
- 34
- Citations by year
- 2026: 11 · 2025: 11 · 2024: 7 · 2023: 10 · 2022: 15 · 2021: 7 · 2020: 7 · 2019: 4 · 2018: 7 · 2017: 4 · 2016: 4
- FWCI
- 5.12
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- British Journal of General Practice (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Open Research Exeter (University of Exeter) (acceptedVersion)
- Open Research Exeter (University of Exeter) (acceptedVersion, cc-by)
- Minerva Access (University of Melbourne) (submittedVersion, cc-by)
- Figshare (submittedVersion, cc-by)
- Figshare (submittedVersion)
- Leicester Research Archive (University of Leicester) (submittedVersion, other-oa)
- Open Research Exeter (University of Exeter) (submittedVersion, other-oa)
- Royal Devon and Exeter Research Repository (Royal Devon and Exeter) (submittedVersion, cc-by)
- Funders
- National Institute for Health and Care Research (CL-2015-23-001, ACF-2009-23-001, CL-2014-23-001, PB-PG-0711-25111, NF-SI-0611-10219, CS-2015-15-018)
- NIHR Exeter Clinical Research Facility
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Keywords
- type 1 diabetes, type 2 diabetes, diabetes classification, insulin-treated diabetes, endogenous insulin production, diagnostic accuracy, age at diagnosis, body mass index, misclassification
- MeSH terms
- C-Peptide, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Female, United Kingdom, Humans, Insulin, Male, ROC Curve, Reproducibility of Results, Biomarkers, Body Mass Index, Practice Guidelines as Topic
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