Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp

Phase 2

Completed

Brief Summary: Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in children with type 1 diabetes in a diabetes camp.

The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia

Detailed Description: Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp.

Recruitment & Eligibility

Inclusion Criteria

Males or females between the 8 and 17 years of old.
Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months.
HbA1c ≤ 11.0%.

Exclusion Criteria

Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
Severe hypoglycemic episode within two weeks of inclusion in the study. A severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit.
Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable.
Known or suspected allergy to the trial products.
Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).

Primary Outcome Measures

Name	Time	Method
Percentage of time of glucose levels spent below 4.0 mmol/L.	Up to 8 hours

Secondary Outcome Measures

Name	Time	Method
Area under the curve of glucose levels below 4.0 mmol/L	Up to 8 hours
Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L	Up to 8 hours
Percentage of time of glucose levels spent above 10 mmol/L.	Up to 8 hours
Area under the curve of glucose levels above 8.0 mmol/L	Up to 8 hours
Total insulin delivery	Up to 8 hours
Standard deviation of glucose levels	Up to 8 hours	Measure of glucose variability.
Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L	Up to 8 hours
Percentage of time of glucose levels spent below 3.5 mmol/L	Up to 8 hours
Percentage of time of glucose levels spent above 8 mmol/L	Up to 8 hours
Area under the curve of glucose levels below 3.5 mmol/L	Up to 8 hours
Area under the curve of glucose levels below 3.3 mmol/L	Up to 8 hours
Mean glucose levels.	Up to 8 hours
Area under the curve of glucose levels above 10.0 mmol/L.	Up to 8 hours
Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L	Up to 8 hours
Percentage of time of glucose levels spent below 3.3 mmol/L	Up to 8 hours

Locations (1): Institut de recherches cliniques de Montréal
🇨🇦
Montreal, Quebec, Canada
Institut de recherches cliniques de Montréal
🇨🇦Montreal, Quebec, Canada