Insulin-based Strategies to Prevent Hypoglycemia During Exercise

McGill University Health Centre/Research Institute of the McGill University Health Centre20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

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 2OTHER

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.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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.).

Locations (2)

Institut de recherches cliniques de Montréal

Montreal, Quebec, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

Decrease in glucose levels

Difference between glucose levels at the beginning of the exercise and the lowest glucose levels from the start of the exercise until the end of exercise