Insulin-based Strategies to Prevent Hypoglycemia During Exercise

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2019-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Reduction of insulin basal rate 40 minutes prior to exercise

Group Type ACTIVE_COMPARATOR

Exercise 2

Intervention Type OTHER

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

Intervention Type DEVICE

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

Insulin

Intervention Type DRUG

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

Insulin pump

Intervention Type DEVICE

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

Reduction of insulin basal rate 90 minutes prior to exercise

Group Type ACTIVE_COMPARATOR

Exercise 1

Intervention Type OTHER

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.

Dexcom G4 Platinum

Intervention Type DEVICE

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

Insulin

Intervention Type DRUG

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

Insulin pump

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Dexcom G4 Platinum

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

Intervention Type DEVICE

Insulin

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

Intervention Type DRUG

Insulin pump

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

Intervention Type DEVICE

Eligibility Criteria

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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.).

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No