Insulin-based Strategies to Prevent Hypoglycemia During Exercise

NCT ID: NCT02631265

Last Updated: 2017-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-09-30

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. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Reduction of insulin basal rate at the time of exercise

Group Type: ACTIVE_COMPARATOR

Exercise 1

Intervention Type: OTHER

Participants will be admitted at IRCM at 14:00. At 15:30, participant's insulin basal rate will be reduced by 80% and participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Reduction of insulin basal rate 20 minutes prior to exercise

Group Type: ACTIVE_COMPARATOR

Exercise 2

Intervention Type: OTHER

Participants will be admitted at IRCM at 14:00. At 15:10, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Reduction of insulin basal rate 40 minutes prior to exercise

Group Type: ACTIVE_COMPARATOR

Exercise 3

Intervention Type: OTHER

Participants will be admitted at IRCM at 14:00. At 14:50, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Interventions

Exercise 1

Participants will be admitted at IRCM at 14:00. At 15:30, participant's insulin basal rate will be reduced by 80% and participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Intervention Type: OTHER

Exercise 2

Participants will be admitted at IRCM at 14:00. At 15:10, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Intervention Type: OTHER

Exercise 3

Participants will be admitted at IRCM at 14:00. At 14:50, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Males and females ≥ 18 years of old.

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

3. The subject will have been on insulin pump therapy for at least 3 months.

4. Last (less than 2 months) HbA1c ≤ 12%.

Exclusion Criteria

1. 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.

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.).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Recherches Cliniques de Montreal

OTHER

Sponsor Role: lead

Responsible Party

Rémi Rabasa-Lhoret

Professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rémi Rabasa-Lhoret

Role: PRINCIPAL_INVESTIGATOR

Institut de recherches cliniques de Montréal

Locations

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

RIDE-1

Identifier Type: -

Identifier Source: org_study_id