Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

An Open-label, Randomized, Cross-over Study to Compare the Efficacy of Single-hormone Closed-loop Strategy and Dual-hormone Closed-loop Strategy at Regulating Glucose Levels During Continuous Exercise and Interval Exercise in Adults With Type-1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01930110
• Other study ID #: CLASS-06
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2013
• Last updated: May 1, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: Institut de Recherches Cliniques de Montreal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review 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 hormones: insulin and glucagon.

The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise.

The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.

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 hormones: insulin and glucagon.

We aim to conduct a randomized two-way cross-over trial comparing single-hormone closed-loop strategy and dual-hormone closed-loop strategy to compare the two interventions during exercise periods in adults with type 1 diabetes. A moderate intensity exercise will be performed for 60 minutes at 60% of the maximum oxygen consumption (VO2max). A high intensity exercise will be 40 minutes of interval training. The interval training will be preceded by a 10 minutes warm-up and followed by a 10 minutes cool down.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females = 18 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.

• Last (less than 3 months) HbA1c = 12%.

Exclusion Criteria:

• Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.

• Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.

• Ongoing pregnancy.

• Severe hypoglycemic episode within two weeks of screening.

• Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).

• Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).

• Problems with venous access

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:
• 60-minute exercise
Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max. Patients will be discharged at 20:00.
• 40-minute interval exercise
Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 40-minute interval exercise. Patients will be discharged at 20:00.

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	Société Francophone du Diabète

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).		18:00 hours to 19:30 hours	No
Secondary	Decrease in glucose levels during each exercise	Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until 30 minutes after exercise).	18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed	No
Secondary	Area under the curve of plasma glucose levels < 4 mmol/L		15:30 hours to 19:30 hours	No
Secondary	Percentage of time of plasma glucose levels < 4 mmol/L		15:30 hours to 19:30 hours	No
Secondary	Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L		15:30 hours to 19:30 hours	No
Secondary	Decremental area under the curve from the start of the exercise for 90 minutes.		18:00 to 19:30	No
Secondary	Percentage of time-in-target defined as between 4 and 10 mmol/L		15:30 hours to 19:30 hours	No
Secondary	Mean time (minutes) to the first hypoglycemic event during the exercise period		18:00 to 19:00	No
Secondary	The amount of dextrose infused		15:30 to 19:30	No