Recruiting

Insulin Strategies

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT03349489

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

Exercise 1

Exercise 2

Dexcom G4 Platinum

Insulin

Insulin pump

Study Details

Brief summary:

It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. The objective of this study will be to compare the efficacy of two strategies to prevent exercise-induced hypoglycemia during a 60-minute exercise at moderate intensity: 1) reduce insulin basal rate 40 minutes prior to exercise; 2) reduce insulin basal rate 90 minutes prior to exercise.

Conditions

Type 1 Diabetes Mellitus

Study ID

NCT03349489

Start date

May 18, 2018

Status verified date

May, 2018

Completion date

Jan, 2019

Anticipated

Primary completion date

Jan, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Males and females ≥ 14 years of old.
2. Clinical diagnosis of type 1 diabetes for at least two years.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. Last (less than 2 months) HbA1c ≤ 10%.

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
2. Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Abnormal blood panel and/or anemia.
4. Ongoing pregnancy.
5. Severe hypoglycemic episode within two weeks of screening.
6. 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).
7. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Reduction of insulin basal rate 40 minutes prior to exercise

active comparator: Reduction of insulin basal rate 90 minutes prior to exercise

Interventions

Exercise 1

Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.

Exercise 2

Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.

Dexcom G4 Platinum

The Dexcom G4 Platinum will be used to measure continuous glucose levels.

Insulin

Participant's usual fast-acting insulin analog will be used.

Insulin pump

Participant's insulin pump will be used to infuse insulin.

Primary outcome measure

  • Decrease in glucose levels [ Time Frame: 60 minutes (exercise period) ]

Central Contacts and Locations

Central contacts

Semah Tagougui

514-987-5500semah.tagougui@ircm.qc.ca

Virginie Messier

514-987-5500virginie.messier@ircm.qc.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Laurent Legault

laurent.legault@muhc.mcgill.ca

Institut de recherches cliniques de Montréal

Recruiting

Montréal, Quebec, Canada, H2W 1R7

Contacts

Semah Tagougui

semah.tagougui@ircm.qc.ca

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

May 22, 2018

Last verified

May, 2018

Keywords

  • Type 1 diabetes
  • Exercise
  • Hypoglycemia
  • Insulin pump

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2018-05-22.