A randomized pilot sleep and circadian behavior clinical trial to improve glycemic and psychological outcomes in young adults with type 1 diabetes (NCT04975230)

一项随机对照试验,旨在通过睡眠和昼夜节律行为改善 1 型糖尿病年轻患者的血糖和心理状况(NCT04975230)

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Abstract

AIMS: To investigate the preliminary efficacy of a cognitive behavioral sleep and circadian intervention on glycemic and psychological outcomes in young adults with type 1 diabetes. METHODS: Glycemic and psychological outcomes were evaluated in 39 young adults (mean age 21.08, diabetes duration 11.7 years, mean glycated hemoglobin 8.46 %, 41 % female) from March 2022 to October 2023. Participants were randomly assigned (1:1) to a 12-week cognitive behavioral sleep and circadian condition (n = 21) or a time-balanced attention control condition (n = 18). Data were collected using continuous glucose monitors, research-grade actigraphy, and daily sleep surveys at baseline, post-intervention, and 3-month follow-up. RESULTS: The cognitive behavioral sleep and circadian intervention condition showed significant improvements in glycemic outcomes, with reductions in the coefficient of variation and mean amplitude of glucose excursions three months post-intervention. It also resulted in decreased diabetes distress at both time points, unlike the Attention Control group, which had minimal changes. CONCLUSIONS: Future research should confirm these preliminary findings in larger, more diverse samples with varied intervention lengths and a longer-term follow-up.

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