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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Other: Insulin-alone closed-loop


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin alone closed-loop<br>Insulin alone closed-loop algorithm in children with type 1 diabetes in a free-living study. | Other: Insulin-alone closed-loop<br>* 40-hour intervention period using the insulin-alone closed-loop system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in range | Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L). | 40-hour intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific time in range | 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. | 40-hour intervention | 
| Specific nighttime time in range | 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. | 40-hour intervention | 
| Mean glucose levels | Mean glucose levels. | 40-hour intervention | 
| Standard deviation of glucose levels and insulin delivery | Standard deviation of glucose levels and insulin delivery. | 40-hour intervention | 
| Coefficient of variance of glucose levels and insulin delivery | Coefficient of variance of glucose levels and insulin delivery. | 40-hour intervention | 
| Total insulin delivery | Total amount of insulin delivered. | 40-hour intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, Artificial Pancreas