Adults with early-onset type 2 diabetes (aged 18–39 years) are severely underrepresented in diabetes clinical research trials
Open Access
- 2 June 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in Diabetologia
- Vol. 63 (8), 1516-1520
- https://doi.org/10.1007/s00125-020-05174-9
Abstract
Aims/hypothesis Early-onset adult type 2 diabetes (diagnosed between ages 18 and 39 years) is increasingly prevalent and associated with poor long-term outcomes. We hypothesised that individuals with early-onset adult type 2 diabetes were underrepresented in the prominent research trials that underpin type 2 diabetes management guidelines. Methods We reviewed the mean age of the study populations recruited to 90 prominent trials in type 2 diabetes, including 37 cardio-renal outcomes trials across a range of pharmacological, non-pharmacological and multifactorial interventions, 28 trials from the phase III programmes of three representative glucose-lowering therapies used routinely in clinical practice (empagliflozin, liraglutide and sitagliptin) and 25 prominent trials of diabetes self-management education and support or intensive lifestyle interventions (diet or supervised exercise training). We then estimated the number of individuals within these trials who were aged between 18 and 39 years. Results Across all 90 trials, the mean age of 268,978 participants was 63 years (range 51–69 years in individual trials). In 73 trials (81%), <5% of participants were estimated to be aged 18–39 years, despite this age group representing ~15–20% of the adult type 2 diabetes population. Twenty-nine of these trials (32%; total 164,953 participants) excluded individuals below 40 years of age altogether. Conclusions/interpretation Guidelines for early-onset adult type 2 diabetes are extrapolated predominantly from evidence in older individuals. Strategies to support the participation of individuals with early-onset adult type 2 diabetes in future research are imperative to ensure guidelines for these high-risk individuals are evidence-based.Funding Information
- University of Leicester
This publication has 13 references indexed in Scilit:
- Phenotypic characteristics and risk factors in a multi-ethnic cohort of young adults with type 2 diabetesCurrent Medical Research and Opinion, 2019
- Age at Diagnosis of Type 2 Diabetes Mellitus and Associations With Cardiovascular and Mortality RisksCirculation, 2019
- Younger people with Type 2 diabetes have poorer self‐care practices compared with older people: results from the Australian National Diabetes AuditDiabetic Medicine, 2018
- Trends in cause-specific mortality among adults with and without diagnosed diabetes in the USA: an epidemiological analysis of linked national survey and vital statistics dataThe Lancet, 2018
- Type 2 diabetes in adolescents and young adultsThe Lancet Diabetes & Endocrinology, 2017
- Metabolic profiles and treatment gaps in young-onset type 2 diabetes in Asia (the JADE programme): a cross-sectional study of a prospective cohortThe Lancet Diabetes & Endocrinology, 2014
- Depression, anxiety and self‐care behaviours of young adults with Type 2 diabetes: results from the International Diabetes Management and Impact for Long‐term Empowerment and Success (MILES) StudyDiabetic Medicine, 2014
- Premature Mortality and Comorbidities in Young-onset Diabetes: A 7-Year Prospective AnalysisThe American Journal of Medicine, 2014
- The needs, concerns, and characteristics of younger Australian adults with Type 2 diabetesDiabetic Medicine, 2012
- Early-onset type 2 diabetes: High risk for premature diabetic retinopathyDiabetes Research and Clinical Practice, 2011