Diabetes Mellitus, Type 1
Conditions
Keywords
Pediatric, Artificial Pancreas
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.
Interventions
OTHERInsulin-alone closed-loop
40-hour intervention period using the insulin-alone closed-loop system.
Sponsors
Eli Lilly and Company
McGill University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female children between 2 and 13 years of age. 2. Clinical diagnosis of type 1 diabetes mellitus (the diagnosis of type 1 diabetes is based on the investigator's judgment). 3. Using insulin pump therapy for at least 3 months 4. 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. 5. Most recent (in the last 6 months) HbA1c ≤ 12%.
Exclusion criteria
1. 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%). 2. Severe hypoglycaemia or ketoacidosis episode ≤ two months before admission. 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time in range | 40-hour intervention | Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Coefficient of variance of glucose levels and insulin delivery | 40-hour intervention | Coefficient of variance of glucose levels and insulin delivery. |
| Total insulin delivery | 40-hour intervention | Total amount of insulin delivered. |
| Standard deviation of glucose levels and insulin delivery | 40-hour intervention | Standard deviation of glucose levels and insulin delivery. |
Countries
Canada
Outcome results
None listed