Developing a multicomponent intervention to increase glucose time in range in adolescents and young adults with type 1 diabetes: An optimisation trial to screen continuous glucose monitoring, sleep extension, healthier snacking and values-guided self-management intervention components

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-21 DOI:10.1016/j.cct.2025.107864

Sara E. Styles , Jillian J. Haszard , Shelley Rose , Barbara C. Galland , Esko J. Wiltshire , Martin I. de Bock , Miriama Ketu-McKenzie , Anna Campbell , Jenny Rayns , Ruth Thomson , Jessica Wong , Craig A. Jefferies , Carmel E. Smart , Benjamin J. Wheeler

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引用次数: 0

Abstract

Aim

The study aimed to identify active intervention components to improve glucose sensor time in range (TIR; 70–180 mg/dL [3.9–10.0 mmol/L]) by ≥5 % among adolescents and young adults (13 to 20 yrs) with type 1 diabetes and above recommended glycated haemoglobin (HbA1c ≥ 7.5 % [≥ 58 mmol/mol]), regardless of current insulin therapy.

Methods

The 6-week optimisation trial used a 2⁴ factorial experiment to estimate the main effects and interactions of the following candidate intervention components on TIR: real-time continuous glucose monitoring (CGM) technology, sleep extension, healthier snacking support, and values-guided self-management. Twenty-one participants, mean (SD) age 16.1 (2.4) years, were randomised to one of 16 experimental conditions.

Results

The main effects, as measured by the mean difference (95 % CI) in TIR from baseline to 4 weeks, were: CGM, 3.3 (−8.8, 15.4) percentage points; sleep extension, −7.2 (−19.0, 4.6) percentage points; snacking support, 0.9 (−11.8, 13.5) percentage points; values-guided self-management, 6.1 (−7.5, 19.7) percentage points.

Conclusions

The values-guided self-management was the only ‘active’ component. Conclusions about the less impactful intervention components are limited due to disruptions in research activities from the COVID-19 pandemic. Future work will address other candidate intervention components.

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开发一种多组分干预措施，以增加青少年和年轻1型糖尿病患者的血糖时间范围：一项筛选连续血糖监测、延长睡眠、健康饮食和价值观指导的自我管理干预成分的优化试验。

目的：研究旨在确定有效干预成分，以改善血糖传感器时间范围(TIR；70-180 mg/dL[3.9-10.0 mmol/L])降低≥5 %推荐糖化血红蛋白（HbA1c ≥ 7.5 %[≥58 mmol/mol]），无论目前的胰岛素治疗。方法：为期6周的优化试验采用24因子实验来评估以下候选干预成分对TIR的主要影响和相互作用：实时连续血糖监测（CGM）技术、睡眠延长、健康零食支持和价值观引导的自我管理。21名参与者，平均（SD）年龄16.1（2.4）岁，随机分配到16个实验条件之一。结果：从基线到4 周，TIR的平均差异（95 % CI）测量的主要效果为：CGM， 3.3（-8.8, 15.4）个百分点；睡眠延长，-7.2（-19.0,4.6）个百分点；支持吃零食，0.9（-11.8,13.5）个百分点；价值观导向的自我管理，6.1%（-7.5,19.7）个百分点。结论：价值观导向的自我管理是唯一的“主动”成分。由于COVID-19大流行对研究活动的干扰，关于影响较小的干预成分的结论有限。未来的工作将解决其他候选干预成分。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.