Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 4:26 PM
Study NCT ID:
NCT04612257
Status:
TERMINATED
Last Update Posted:
2023-07-12
First Post:
2020-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Closed-loop Insulin Delivery in Children With Type 1 Diabetes.
Sponsor:
McGill University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor has requested to end the study prematurely due to the accumulation of delays caused by COVID-19 as potential participants were hesitant to allow staff members into their homes or stay at the hospital per the study design.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: