Insulin-based Strategies to Prevent Hypoglycemia During Exercise

McGill University

Status: Unknown

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Dexcom G4 Platinum; Device: Insulin pump; Drug: Insulin; Other: Exercise 2; Other: Exercise 1

Study type: Interventional

Funder types: Other

Identifiers

NCT03349489

RIDE-1 bis

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Reduction of insulin basal rate 40 minutes prior to exercise

Active Comparator group

Treatment:

Device: Dexcom G4 Platinum

Other: Exercise 2

Device: Insulin pump

Drug: Insulin

Reduction of insulin basal rate 90 minutes prior to exercise

Active Comparator group

Treatment:

Device: Dexcom G4 Platinum

Other: Exercise 1

Device: Insulin pump

Drug: Insulin