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Published online: 2024-07-11

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Randomized Controlled Trials Dedicated to Older Patients with Type 2 Diabetes: A Systematic Review

Maksymilian Sito1, Danuta Kłosowska2, Leszek Pączek2, Jan Borysowski2

Abstract

Objective: Older adults with type 2 diabetes (T2D) comprise a very diverse population regarding their age, comorbidities, and frailty status, and their treatment goals may be different from those typical of younger patients. The objective of this study was to assess participants’ characteristics and the primary endpoints of randomized controlled trials (RCTs) dedicated to older adults with T2D. Materials and methods: This study was a systematic review of RCTs enrolling solely patients with T2D aged 60 years or older published from 1994 through 2023. Eligible trials were searched for in PubMed, Embase, and Cochrane Central. Results: The review included 35 RCTs (9068 participants). The weighted mean age of RCT participants was 71.4 years (co-primary outcome). The proportion of patients aged 75 years or older was reported in 11 (31%) RCTs; it was 27%. Proportion of patients with frailty was reported in 2 (6%) trials (co-primary outcome). The proportion of patients with different burden of comorbidities was provided in one (3%) RCT (co-primary outcome). The primary endpoints mostly (n = 25; 71%) involved HbA1c. A composite primary endpoint (reduction of HbA1c without significant hypoglycemia) was used in 2 (6%) trials. The results for the primary endpoints were generally positive. Conclusions: Most of the analyzed RCTs did not report the key participants characteristics. The primary endpoints did not involve outcome measures particularly relevant to older patients. Modifications of the design and reporting of RCTs should be considered to translate their results into optimal clinical care of older adults with T2D.

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