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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02189694
• Other study ID #: CLASS-08
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2014
• Last updated: September 1, 2014
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Research Ethic Board
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Single-hormone closed-loop strategy
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
• Dual-hormone closed-loop strategy
Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.
• Insulin pump therapy
Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal	Montreal Children's Hospital of the MUHC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time of glucose levels spent below 4.0 mmol/L.		Up to 8 hours	No
Secondary	Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L		Up to 8 hours	No
Secondary	Percentage of time of glucose levels spent below 3.5 mmol/L		Up to 8 hours	No
Secondary	Percentage of time of glucose levels spent below 3.3 mmol/L		Up to 8 hours	No
Secondary	Percentage of time of glucose levels spent above 8 mmol/L		Up to 8 hours	No
Secondary	Percentage of time of glucose levels spent above 10 mmol/L.		Up to 8 hours	No
Secondary	Area under the curve of glucose levels below 4.0 mmol/L		Up to 8 hours	No
Secondary	Area under the curve of glucose levels below 3.5 mmol/L		Up to 8 hours	No
Secondary	Area under the curve of glucose levels below 3.3 mmol/L		Up to 8 hours	No
Secondary	Area under the curve of glucose levels above 8.0 mmol/L		Up to 8 hours	No
Secondary	Area under the curve of glucose levels above 10.0 mmol/L.		Up to 8 hours	No
Secondary	Mean glucose levels.		Up to 8 hours	No
Secondary	Standard deviation of glucose levels	Measure of glucose variability.	Up to 8 hours	No
Secondary	Total insulin delivery		Up to 8 hours	No
Secondary	Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L		Up to 8 hours	No
Secondary	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	No