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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Institut de Recherches Cliniques de Montreal
Sponsor:
Collaborator:
Société Francophone du Diabète
Information provided by (Responsible Party):
Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier:
NCT01930110
First received: August 23, 2013
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Other: 60-minute exercise
Other: 40-minute interval exercise
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Institut de Recherches Cliniques de Montreal:

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). [ Time Frame: 18:00 hours to 19:30 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in glucose levels during each exercise [ Time Frame: 18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed ] [ Designated as safety issue: No ]
    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 [ Time Frame: 15:30 hours to 19:30 hours ] [ Designated as safety issue: No ]
  • Percentage of time of plasma glucose levels < 4 mmol/L [ Time Frame: 15:30 hours to 19:30 hours ] [ Designated as safety issue: No ]
  • Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L [ Time Frame: 15:30 hours to 19:30 hours ] [ Designated as safety issue: No ]
  • Decremental area under the curve from the start of the exercise for 90 minutes. [ Time Frame: 18:00 to 19:30 ] [ Designated as safety issue: No ]
  • Percentage of time-in-target defined as between 4 and 10 mmol/L [ Time Frame: 15:30 hours to 19:30 hours ] [ Designated as safety issue: No ]
  • Mean time (minutes) to the first hypoglycemic event during the exercise period [ Time Frame: 18:00 to 19:00 ] [ Designated as safety issue: No ]
  • The amount of dextrose infused [ Time Frame: 15:30 to 19:30 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: April 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single-hormone closed-loop system
In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels
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.
Other: 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.
Active Comparator: Dual-hormone closed-loop system
In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels
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.
Other: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930110

Contacts
Contact: Virginie Messier 514-987-5500 ext 3227 virginie.messier@ircm.qc.ca

Locations
Canada, Quebec
Institut de recherches cliniques de Montréal Recruiting
Montreal, Quebec, Canada, H2W 1R7
Contact: Virginie Messier, MsC    514-987-5500 ext 3227      
Sponsors and Collaborators
Institut de Recherches Cliniques de Montreal
Société Francophone du Diabète
Investigators
Principal Investigator: Rémi Rabasa-Lhoret, MD, PhD Institut de recherches cliniques de Montréal
  More Information

No publications provided

Responsible Party: Rémi Rabasa-Lhoret, Associate professor of Medicine, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT01930110     History of Changes
Other Study ID Numbers: CLASS-06
Study First Received: August 23, 2013
Last Updated: April 8, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Institut de Recherches Cliniques de Montreal:
Type 1 diabetes
Hypoglycemia
Insulin
Glucagon
Closed-loop system
Artificial pancreas

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014