Safety and Efficacy of Artificial Pancreas With and Without a Meal Detection Module on Glycemic Control in Adolescents With Type 1 Diabetes After a Missed Bolus

Diabetes Mellitus, Type 1 Clinical Trial

Official title:
An Open-label, Randomized, Three-way, Crossover Study to Assess the Safety and Efficacy of Closed-loop Delivery With and Without Meal Detection Module and Conventional Pump Therapy in Regulating Glucose Levels After a Missed Bolus in Adolescents With Type 1 Diabetes in Inpatient Settings

Status Completed

Clinical Trial Summary

Clinical Trial Description

Despite current treatments for type 1 diabetes, maintaining blood glucose levels within a good range is a difficult task. A primary source for poor glucose control in adolescents is skipping insulin boluses at mealtimes. Advances in glucose sensors have motivated the research towards closed-loop delivery systems to automatically regulate glucose levels. Closed-loop delivery (artificial pancreas) is composed of an insulin pump, a continuous glucose sensor and a dosing algorithm that calculates the insulin dose to infuse based on sensor readings. The performance of a closed-loop delivery after a missed bolus may be improved if the computer program that calculates the insulin is enhanced with a meal detection module. The meal detection module will automatically detect the meal (which had no bolus delivered), and signal the delivery of more insulin.

The aim of this study is to conduct a randomized, three-way, cross-over trial to compare the efficacy of closed-loop delivery, closed-loop delivery with a meal detection module, and conventional pump therapy. The study aims to compare these three interventions for 9 hours in adolescents with poorly controlled type 1 diabetes.

Each 9 hours will include two meals of different carbohydrate content, of which one will not have a carbohydrate-matched prandial bolus. This study will allow for the assessment of the safety and efficacy of closed-loop delivery with and without a meal detection module compared to conventional pump therapy in regulating post-prandial glycaemia.

The aim of this study is to assess the safety and efficacy of a closed-loop delivery with and without meal detection module compared to conventional pump therapy in regulating post-prandial glycemic levels after omission of a meal bolus.

The primary hypothesis is that closed-loop delivery with no meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.

The secondary hypotheses are:

1. Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to conventional pump therapy.

2. Closed-loop delivery with meal detection module will reduce the mean increase in postprandial glucose levels after a missed bolus compared to closed-loop delivery with no meal detection module. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02909829
Study type	Interventional
Source	McGill University
Contact
Status	Completed
Phase	N/A
Start date	October 31, 2017
Completion date	October 11, 2019

View Details

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