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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

60-minute exercise

40-minute interval exercise

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Single-hormone closed-loop system

Dual-hormone closed-loop system

Arm Description

In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels

In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels

Outcomes

Primary Outcome Measures

The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).

Secondary Outcome Measures

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).

Area under the curve of plasma glucose levels < 4 mmol/L

Percentage of time of plasma glucose levels < 4 mmol/L

Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L

Decremental area under the curve from the start of the exercise for 90 minutes.

Percentage of time-in-target defined as between 4 and 10 mmol/L

Mean time (minutes) to the first hypoglycemic event during the exercise period

The amount of dextrose infused

Full Information

NCT ID

NCT01930110

First Posted

August 23, 2013

Last Updated

May 1, 2015

Sponsor

Institut de Recherches Cliniques de Montreal

Collaborators

Société Francophone du Diabète

1. Study Identification

Unique Protocol Identification Number

NCT01930110

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

April 2014 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institut de Recherches Cliniques de Montreal

Collaborators

Société Francophone du Diabète

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single-hormone closed-loop system

Arm Type

Active Comparator

Arm Description

In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels

Arm Title

Dual-hormone closed-loop system

Arm Type

Active Comparator

Arm Description

In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels

Intervention Type

Other

Intervention Name(s)

60-minute exercise

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

40-minute interval exercise

Intervention Description

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.

Primary Outcome Measure Information:

Title

The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms).

Time Frame

18:00 hours to 19:30 hours

Secondary Outcome Measure Information:

Title

Decrease in glucose levels during each exercise

Description

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).

Time Frame

18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed

Title

Area under the curve of plasma glucose levels < 4 mmol/L

Time Frame

15:30 hours to 19:30 hours

Title

Percentage of time of plasma glucose levels < 4 mmol/L

Time Frame

15:30 hours to 19:30 hours

Title

Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L

Time Frame

15:30 hours to 19:30 hours

Title

Decremental area under the curve from the start of the exercise for 90 minutes.

Time Frame

18:00 to 19:30

Title

Percentage of time-in-target defined as between 4 and 10 mmol/L

Time Frame

15:30 hours to 19:30 hours

Title

Mean time (minutes) to the first hypoglycemic event during the exercise period

Time Frame

18:00 to 19:00

Title

The amount of dextrose infused

Time Frame

15:30 to 19:30

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rémi Rabasa-Lhoret, MD, PhD

Organizational Affiliation

Institut de recherches cliniques de Montréal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de recherches cliniques de Montréal

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1R7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

27704167

Citation

Taleb N, Emami A, Suppere C, Messier V, Legault L, Ladouceur M, Chiasson JL, Haidar A, Rabasa-Lhoret R. Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. Diabetologia. 2016 Dec;59(12):2561-2571. doi: 10.1007/s00125-016-4107-0. Epub 2016 Oct 4.

Results Reference

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

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