Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

An Open-label, Randomized, Three-way, Multicenter Study to Compare the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Overnight Glucose Levels at Home in Adolescents and Adults With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01905020
• Other study ID #: CLASS-04
• Status: Completed
• Phase: Phase 2
• First received: July 12, 2013
• Last updated: October 18, 2014
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2014
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: research ethic committee
• 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 a out-patient study in adults and adolescents with type 1 diabetes.

The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.

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.

We aim to conduct a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Males and females aged = 12 years of old.

• Body mass index < 35

• Clinical diagnosis of type 1 diabetes for at least one year.

• The subject will have been on insulin pump therapy for at least 4 months.

• HbA1c < 12%.

• At least two visits with an endocrinology team in the past 1 year.

Exclusion Criteria:

• Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.

• Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

• A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.

• Ongoing pregnancy.

• Severe hypoglycemic episode within two weeks of screening.

• Current use of glucocorticoid medication (except low stable dose and inhaled therapy).

• Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..

• Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.

• Anticipating a significant change in treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.

• Failure to comply with team's recommendations.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Carbohydrate-rich meal
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
• Exercise
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.

Locations

Country	Name	City	State
Canada	Institut de recherches cliniques de Montréal	Montreal	Quebec
Canada	Montreal Children Hospital	Montreal	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Institut de Recherches Cliniques de Montreal	McGill University, Montreal Children's Hospital of the MUHC, Mount Sinai Hospital, New York

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time in target range	Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range. Target range is defined to be between 4.0 to 8.0 mmol/L	8 hours	No
Secondary	Percentage of time in target range for each night separately	Percentage of time for which glucose levels are in target range for each night separately. Target range is defined to be between 4.0 and 8.0 mmol/L.	8 hours	No
Secondary	Percentage of time in target range for the pooled data	Percentage of time for which glucose levels are in target range for the pooled data. Target range is defined to be between 4.0 to 8.0 mmol/L.	8 hours	No
Secondary	Percentage of time spent below 4.0 mmol/L	Percentage of time for which glucose levels are below 4.0 mmol/L.	8 hours	No
Secondary	Percentage of time spent below 3.3 mmol/L	Percentage of time for which glucose levels are spent below 3.3 mmol/L.	8 hours	No
Secondary	Area under the curve for glucose levels below 4.0 mmol/L		8 hours	No
Secondary	Area under the curve for glucose levels below 3.3 mmol/L		8 hours	No
Secondary	Percentage of time spent above 8.0 mmol/L	Percentage of time for which glucose levels are above 8.0 mmol/L	8 hours	No
Secondary	Percentage of time spent above 10.0 mmol/L	Percentage of time for which glucose levels are above 10.0 mmol/L.	8 hours	No
Secondary	Area under the curve for glucose levels spent above 8.0 mmol/L		8 hours	No
Secondary	Area under the curve for glucose levels spent above 10.0 mmol/L		8 hours	No
Secondary	Mean glucose levels		8 hours	No
Secondary	Standard deviation of glucose levels	Standard deviation of glucose levels as a measure of glucose variability.	8 hours	No
Secondary	Total insulin delivery		8 hours	No
Secondary	Number of subjects experiencing at least one hypoglycemic event requiring treatment		8 hours	No
Secondary	Number of hypoglycemic events requiring treatment		8 hours	No