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

Phase 2

Completed

Conditions: Type 1 Diabetes

Interventions: Device: Dual-hormone closed-loop strategy
Device: Single-hormone closed-loop strategy
Device: Insulin pump therapy

Registration Number: NCT02189694

Lead Sponsor: Institut de Recherches Cliniques de Montreal

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

Status: COMPLETED

Sex: All

Target Recruitment: 33

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dual-hormone closed-loop strategy	Dual-hormone closed-loop strategy	Glucose levels will be controlled by dual-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by dual-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor readings will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses. Pumps' parameters will then be changed manually to implement the computer generated recommendations.
Single-hormone closed-loop strategy	Single-hormone closed-loop strategy	Glucose levels will be controlled by single-hormone closed-loop strategy for 3 consecutive nights. A member of the research team will be present at the diabetic camp to ensure protocol implementation and patient's safety. Glucose levels will be controlled by single-hormone closed-loop strategy between 22:00 until 7:00 next morning. Glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pump's parameters will then be changed manually to implement the computer generated recommendations.
Insulin pump therapy	Insulin pump therapy	Glucose levels will be controlled for 3 consecutive nights using insulin pump therapy. Subjects will carry on with their normal conventional insulin pump therapy and will be allowed to freely implement therapeutic adjustments..

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
Percentage of time of glucose levels spent below 3.3 mmol/L	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

Trial Locations

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