Clinical trial NCT02189694: Closed-loop Control of Overnight Glucose Levels (Artificial Pancreas) in Children With Type 1 Diabetes in a Diabetes Camp
Official title: An Open-label, Randomized, Three-way, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Pump Therapy in Regulating Overnight Glucose Levels in Children With Type 1 Diabetes in a Diabetes Camp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Hypoglycemia
Insulin
Glucagon
Closed-loop system
Artificial pancreas
Lead sponsor: Institut de Recherches Cliniques de Montreal
Sponsor class: OTHER
Collaborators: name: Montreal Children's Hospital of the MUHC
First posted: 2014-07-14
Enrollment: 33
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: Percentage of time of glucose levels spent below 4.0 mmol/L.
timeFrame: Up to 8 hours
Secondary outcomes:
measure: Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L
timeFrame: Up to 8 hours
measure: Percentage of time of glucose levels spent below 3.5 mmol/L
timeFrame: Up to 8 hours
measure: Percentage of time of glucose levels spent below 3.3 mmol/L
timeFrame: Up to 8 hours
measure: Percentage of time of glucose levels spent above 8 mmol/L
timeFrame: Up to 8 hours
measure: Percentage of time of glucose levels spent above 10 mmol/L.
timeFrame: Up to 8 hours
measure: Area under the curve of glucose levels below 4.0 mmol/L
timeFrame: Up to 8 hours
measure: Area under the curve of glucose levels below 3.5 mmol/L
timeFrame: Up to 8 hours
measure: Area under the curve of glucose levels below 3.3 mmol/L
timeFrame: Up to 8 hours
measure: Area under the curve of glucose levels above 8.0 mmol/L
timeFrame: Up to 8 hours
measure: Area under the curve of glucose levels above 10.0 mmol/L.
timeFrame: Up to 8 hours
measure: Mean glucose levels.
timeFrame: Up to 8 hours
measure: Standard deviation of glucose levels
timeFrame: Up to 8 hours
measure: Total insulin delivery
timeFrame: Up to 8 hours
measure: Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L
timeFrame: Up to 8 hours
measure: Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L
timeFrame: Up to 8 hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Institut de recherches cliniques de Montréal
state: Quebec
Study officials:
affiliation: Institut de recherches cliniques de Montréal
name: Rémi Rabasa-Lhoret, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haidar A, Legault L, Matteau-Pelletier L, Messier V, Dallaire M, Ladouceur M, Rabasa-Lhoret R. Outpatient overnight glucose control with dual-hormone artificial pancreas, single-hormone artificial pancreas, or conventional insulin pump therapy in children and adolescents with type 1 diabetes: an open-label, randomised controlled trial. Lancet Diabetes Endocrinol. 2015 Aug;3(8):595-604. doi: 10.1016/S2213-8587(15)00141-2. Epub 2015 Jun 8.