Assessing Closed-loop Insulin Delivery in Children With Type 1 Diabetes.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 1
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The pilot study aims to enroll 20 children participants with type 1 diabetes mellitus using insulin pump therapy. Each participant will undergo a 40-hour intervention period, with the possibility of being invited to a second 40-hour intervention period using the same system.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 2 years and 13 years
- Gender
- Both males and females
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 com...
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.
Tracking Information
- NCT #
- NCT04612257
- Collaborators
- Eli Lilly and Company
- Investigators
- Principal Investigator: Laurent Legault, MD Montreal Children's Hospital of the MUHC
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