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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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.