Assessing Closed-loop Insulin Delivery in Children With Type 1 Diabetes.
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Other: Insulin-alone closed-loop
- Registration Number
- NCT04612257
- Lead Sponsor
- McGill University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 10
- 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%.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin alone closed-loop Insulin-alone closed-loop Insulin alone closed-loop algorithm in children with type 1 diabetes in a free-living study.
- Primary Outcome Measures
Name Time Method Time in range 40-hour intervention Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L).
- Secondary Outcome Measures
Name Time Method Specific nighttime time in range 40-hour intervention Percentage of time (00:00-6:00) of glucose levels spent a. below 3.9 mmol/L; b. between 3.9 and 7.8 mmol/L; c. between 3.9 and 10.0 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 10.0 mmol/L; g. above 13.9 mmol/L; h. above 16.7 mmol/L.
Coefficient of variance of glucose levels and insulin delivery 40-hour intervention Coefficient of variance of glucose levels and insulin delivery.
Mean glucose levels 40-hour intervention Mean glucose levels.
Specific time in range 40-hour intervention Percentage of time of glucose levels spent a. between 3.9 and 7.8 mmol/L; b. below 3.9 mmol/L; c. below 3.3 mmol/L; d. below 2.8 mmol/L; e. above 10.0 mmol/L; f. above 13.9 mmol/L; g. above 16.7 mmol/L.
Standard deviation of glucose levels and insulin delivery 40-hour intervention Standard deviation of glucose levels and insulin delivery.
Total insulin delivery 40-hour intervention Total amount of insulin delivered.
Trial Locations
- Locations (1)
McGill University Health Centre Research Institute
🇨🇦Montréal, Quebec, Canada