Assessing the efficacy, safety and utility of 6-month day-and-night automated closed-loop insulin delivery under free-living conditions compared with insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, multicentre, multinational, single-period, randomised, parallel group study protocol.

ABSTRACT: INTRODUCTION:Closed-loop systems titrate insulin based on sensor glucose levels, providing novel means to reduce the risk of hypoglycaemia while improving glycaemic control. We will assess effectiveness of 6-month day-and-night closed-loop insulin delivery compared with usual care (conventional or sensor-augmented pump therapy) in children and adolescents with type 1 diabetes. METHODS AND ANALYSIS:The trial adopts an open-label, multicentre, multinational (UK and USA), randomised, single-period, parallel design. Participants (n=130) are children and adolescents (aged ?6?and <19 years) with type 1 diabetes for at least 1?year, and insulin pump use for at least 3 months with suboptimal glycaemic control (glycated haemoglobin ?58?mmol/mol (7.5%) and ?86?mmol/mol (10%)). After a 2-3?week run-in period, participants will be randomised to 6-month use of hybrid closed-loop insulin delivery, or to usual care. Analyses will be conducted on an intention-to-treat basis. The primary outcome is glycated haemoglobin at 6 months. Other key endpoints include time in the target glucose range (3.9-10?mmol/L, 70-180?mg/dL), mean sensor glucose and time spent above and below target. Secondary outcomes include SD and coefficient of variation of sensor glucose levels, time with sensor glucose levels <3.5?mmol/L (63?mg/dL) and <3.0?mmol/L (54?mg/dL), area under the curve of glucose <3.5?mmol/L (63?mg/dL), time with glucose levels >16.7?mmol/L (300?mg/dL), area under the curve of glucose >10.0?mmol/L (180?mg/dL), total, basal and bolus insulin dose, body mass index z-score and blood pressure. Cognitive, emotional and behavioural characteristics of participants and caregivers and their responses to the closed-loop and clinical trial will be assessed. An incremental cost-effectiveness ratio for closed-loop will be estimated. ETHICS AND DISSEMINATION:Cambridge South Research Ethics Committee and Jaeb Center for Health Research Institutional Review Office approved the study. The findings will be disseminated by peer-review publications and conference presentations. TRIAL REGISTRATION NUMBER:NCT02925299; Pre-results.

SUBMITTER: Musolino G 

PROVIDER: S-EPMC6561428 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature