BMJ open · 2023
Efficacy and safety of Android artificial pancreas system use at home among adults with type 1 diabetes mellitus in China: protocol of a 26-week, free-living, randomised, open-label, two-arm, two-phase, crossover trial.
Протокол клинического исследованияСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Lei Mengyun, Lin Beisi, Ling Ping, Liu Zhigu, Yang Daizhi, Deng Hongrong, Yang Xubin, Lv Jing, Xu Wen, Yan Jinhua
Аннотация
INTRODUCTION: Do-it-yourself artificial pancreas system (DIY APS) is built using commercially available insulin pump, continuous glucose monitoring (CGM) and an open-source algorithm. Compared with commercial products, DIY systems are affordable, allow personalised settings and provide updated algorithms, making them a more promising therapy for most patients with type 1 diabetes mellitus (T1DM). Many small and self-reported observational studies have found that their real-world use was associated with potential metabolic and psychological benefits. However, rigorous-designed studies are urgently needed to confirm its efficacy and safety.
METHODS AND ANALYSIS: In this 26-week randomised, open-label, two-arm, two-phase, crossover trial, participants aged 18-75 years, with T1DM and glycated haemoglobin (HbA1c) 7-11%, will use AndroidAPS during one 12-week period and sensor-augmented pump during another 12-week period. This study will recruit at least 24 randomised participants. AndroidAPS consists of three components: (1) real-time CGM; (2) insulin pump; (3) AndroidAPS algorithm implemented in Android smartphone. The primary endpoint is time in range (3.9-10.0 mmol/L) derived from CGM. The main secondary endpoints include percentage of sensor glucose values below, within and above target range; mean sensor glucose value; measures of glycaemic variability and centralised HbA1c. Safety endpoints mainly include the frequency of hypoglycaemia events, diabetic ketoacidosis and other serious adverse events.
ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University. There will be verbal and written information regarding the trial given to each participant. The study will be disseminated through peer-reviewed publications and conference presentations.
OVERALL STATUS: Recruiting.
STUDY START: 11 February 2023.
PRIMARY COMPLETION: 31 July 2024.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05726461).
METHODS AND ANALYSIS: In this 26-week randomised, open-label, two-arm, two-phase, crossover trial, participants aged 18-75 years, with T1DM and glycated haemoglobin (HbA1c) 7-11%, will use AndroidAPS during one 12-week period and sensor-augmented pump during another 12-week period. This study will recruit at least 24 randomised participants. AndroidAPS consists of three components: (1) real-time CGM; (2) insulin pump; (3) AndroidAPS algorithm implemented in Android smartphone. The primary endpoint is time in range (3.9-10.0 mmol/L) derived from CGM. The main secondary endpoints include percentage of sensor glucose values below, within and above target range; mean sensor glucose value; measures of glycaemic variability and centralised HbA1c. Safety endpoints mainly include the frequency of hypoglycaemia events, diabetic ketoacidosis and other serious adverse events.
ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University. There will be verbal and written information regarding the trial given to each participant. The study will be disseminated through peer-reviewed publications and conference presentations.
OVERALL STATUS: Recruiting.
STUDY START: 11 February 2023.
PRIMARY COMPLETION: 31 July 2024.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05726461).