Assessing the effectiveness of a 3-month day-and-night home closed-loop control combined with pump suspend feature compared with sensor-augmented pump therapy in youths and adults with suboptimally controlled type 1 diabetes: a randomised parallel study protocol

Abstract

Introduction: Despite therapeutic advances, many individuals with type 1 diabetes are unable to achieve tight glycaemic target without increasing the risk of hypoglycaemia. The objective of this study is to determine the effectiveness of a 3-month day-and-night home closed-loop glucose control combined with a pump suspend feature, compared with sensor-augmented insulin pump therapy in youths and adults with suboptimally controlled type 1 diabetes.

Methods and analysis: The study adopts an open-label, multi-centre, multi-national (UK and USA), randomised, single-period, parallel design and aims for 84 randomised patients. Participants are youths (6-21 years) or adults (>21 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) ≥7.5% (58 mmol/mol) and ≤10% (86 mmol/mol)). Following a 4-week run-in period, eligible participants will be randomised to a 3-month use of automated closed-loop insulin delivery combined with pump suspend feature or to sensor-augmented insulin pump therapy. Analyses will be conducted on an intention-to-treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3-month free-living phase. Secondary outcomes include HbA1c at 3 months, mean glucose, time spent below and above target; time with glucose levels <3.5 and <2.8 mmol/L; area under the curve when sensor glucose is <3.5 mmol/L, time with glucose levels >16.7 mmol/L, glucose variability; total, basal and bolus insulin dose and change in body weight. Participants' and their families' perception in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be evaluated.

Ethics and dissemination: Ethics/institutional review board approval has been obtained. Before screening, all participants/guardians will be provided with oral and written information about the trial. The study will be disseminated by peer-reviewed publications and conference presentations.

Trial registration number: NCT02523131; Pre-results.

Keywords: artificial pancreas; closed-loop; type 1 diabetes.

Conflict of interest statement

Competing interests: SH serves as a consultant for Novo-Nordisk and for the ONSET group and reports having received speaker/training honoraria from Medtronic. MLE reports having received speaker honoraria from Abbott Diabetes Care, Novo Nordisk and Animas and serving on advisory panels for Novo Nordisk, Abbott Diabetes Care, Medtronic, Roche and Cellnovo. RH reports having received speaker honoraria from Eli Lilly, Novo Nordisk and Astra Zeneca; serving on advisory panel for Eli Lilly and Novo Nordisk; receiving license fees from BBraun and Medtronic and having served as a consultant to BBraun. MEW has received license fees from Becton Dickinson and has served as a consultant to Beckton Dickinson. MT reports having received speaker honoraria from Novo Nordisk and Medtronic. RH and MEW report patent patents and patent applications. LL reports having received speaker honoraria from Minimed Medtronic, Animas, Sanofi and Novo Nordisk and serving on advisory panel for Animas Minimed Medtronic and Novo Nordisk. VNS had received speaking fees from the Dexcom Inc. VNS employer received research funding from T1D Exchange and Sanofi. LB, HT, JMA, JE, VH, JS, SB, PC, MB, JL, DE, CLA, FC, AC, MLE, DBD, CK and RMB declare no competing financial interests exist.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1

Study flow chart. CGM, continuous glucose monitoring; HbA1c, glycated haemoglobin.

Figure 2

Closed-loop system prototype. (A) Components of the FlorenceM closed-loop system consist of a continuous glucose monitoring (CGM) transmitter with Enlite 3 sensor, an insulin pump (modified 640G pump) integrated with the CGM receiver and a mobile phone running the control algorithm. (B) A photo of a participant (obtained with consent) using the closed-loop system.