NCT04612257

Assessing Closed-loop Insulin Delivery in Children With Type 1 Diabetes.

A Pilot Study to Assess Closed-loop Insulin Delivery to Regulate Glucose Levels in Children With Type 1 Diabetes in Outpatient Free-living Settings.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 2 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial is to assess the safety of our insulin dosing algorithm in children with type 1 diabetes in a free-living study.

Detailed description

This is a preliminary pilot study to generate data to optimize an insulin dosing algorithm to regulate glucose levels in children with type 1 diabetes. There will be up to two 40-hour test in outpatient settings, in which we will assess an insulin dosing algorithm. The two tests will allow us to compare different tunings in the same patient (this allows easier interpretation of the data). For example, if in a specific participant, the dosing algorithm reduced insulin delivery at night to avoid low blood glucose levesl but led to a rebound increase in glucose levels, then a second visit with a slightly different target range will help answer this question. The objective of this clinical trial is to assess the safety of our algorithm in children with type 1 diabetes in a free-living study.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
OTHER	Insulin-alone closed-loop	40-hour intervention period using the insulin-alone closed-loop system.

Timeline

• Start date: 2019-06-18
• Primary completion: 2022-06-13
• Completion: 2022-06-13
• First posted: 2020-11-02
• Last updated: 2023-07-12

Locations

1 site across 1 country: Canada