A Pilot Study to Assess Closed-loop Insulin Delivery to Regulate Glucose Levels in Children With Type 1 Diabetes in Outpatient Free-living Settings.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- McGill University
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Time in range
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female children between 2 and 13 years of age.
- •Clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment).
- •Using insulin pump therapy for at least 3 months
- •For participants aged 7-13 years: Total daily insulin dose ≤ 40 units and 0.5 ≥ units/kg/day. For participants aged 2-6 years: Total daily insulin dose [8, 40] units and 0.3 ≥ units/kg/day.
- •Most recent (in the last 6 months) HbA1c ≤ 12%.
Exclusion Criteria
- •Using Medtronic 670G automated insulin delivery system (since participant's basal rates and insulin-to-carbohydrate ratios may reflect the use of 670G; generally overestimated by 20%).
- •Severe hypoglycaemia or ketoacidosis episode ≤ two months before admission.
- •Medical illness or other issues likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Arms & Interventions
Insulin alone closed-loop
Insulin alone closed-loop algorithm in children with type 1 diabetes in a free-living study.
Intervention: Insulin-alone closed-loop (Other)
Outcomes
Primary Outcomes
Time in range
Time Frame: 40-hour intervention
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
Secondary Outcomes
- Specific nighttime time in range(40-hour intervention)
- Coefficient of variance of glucose levels and insulin delivery(40-hour intervention)
- Mean glucose levels(40-hour intervention)
- Specific time in range(40-hour intervention)
- Standard deviation of glucose levels and insulin delivery(40-hour intervention)
- Total insulin delivery(40-hour intervention)