Interventions to preserve beta cell function in patients with newly diagnosed type 1 diabetes: An updated descriptive analysis of time trends in randomised controlled trials (RCTs) identified in a systematic review (2025)

Type of publication:

Conference abstract

Author(s):

Beese S.E.; Gerard C.; Narendran P.; Price M.J.; Quinn L.; Gada R.; *Horgan T.J.; Andrews R.C.; Moore D.J.; Tomlinson C.; Sharma P.; Harris I.M.; Adriano A.; Maggs F.; Burrows M.;

Citation:

Diabetic Medicine. Conference: Diabetes UK Professional Conference 2025. Glasgow . 42(Supplement 1) (no pagination), 2025. Date of Publication: 01 Feb 2025.

Abstract:

Aims: In newly diagnosed type 1 diabetes, residual beta cell function (indicated by c-peptide) is associated with improved glucose control and reduced long-term complications. We assessed time trends in RCTs of categories of interventions for beta cell preservation in newly diagnosed type 1 diabetes. Method(s): RCTs of any intervention for newly diagnosed type 1 diabetes measuring c-peptide were identified in Cochrane CENTRAL, MEDLINE, Embase and trials registries (to July 2024). Trends in trial characteristics were assessed, focusing on types of intervention. Result(s): The 171 completed published trials were distributed across non-antigen-specific (NAS) immunomodulatory therapies (n = 60, 33%), vitamins (n = 23, 13%), antigen-specific immunotherapies (n = 20, 11%), interventions to maintain glucose control (n = 38, 21%) and 'other' interventions (n = 39, 22%). A further 102 ongoing/ unpublished trials were included. Over 40 years, RCT frequency has increased, with 54 trials published between 2011 and 2020 and 39 since 2021. Twenty-four ongoing trials of 'other' interventions and 19 NAS trials have been initiated since 2021. Average sample size per trial has increased from 63 (SD 66) prior to 2014 to 83 (SD 110) in the last 10 years. Taking the NAS group as an example, time from completion of data collection to publication has increased. Trials with significant primary endpoint results are published 6 months quicker than non-significant findings (mean 17.6 vs 23 months). The number of NAS trials with significant results has risen from 40% (13/33) to 61% (16/26). Conclusion(s): RCTs of therapies to preserve beta cells are increasing in frequency with greater focus on NAS interventions and therapies not easily fitting standard categories. Significant findings may be published sooner.

DOI: 10.1111/dme.15498