Insulin-based Strategies to Prevent Hypoglycemia During Exercise

Not Applicable

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Exercise 1; Other: Exercise 2; Device: Dexcom G4 Platinum; Drug: Insulin; Device: Insulin pump

• Registration Number: NCT03349489
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-11-17
• Study First Posted: 2017-11-21
• Status Verified: 2018-05
• Study Start: 2018-05-18
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reduction of insulin basal rate 90 minutes prior to exercise	Exercise 1	-
Reduction of insulin basal rate 40 minutes prior to exercise	Dexcom G4 Platinum	-
Reduction of insulin basal rate 40 minutes prior to exercise	Insulin pump	-
Reduction of insulin basal rate 90 minutes prior to exercise	Insulin	-
Reduction of insulin basal rate 40 minutes prior to exercise	Insulin	-
Reduction of insulin basal rate 90 minutes prior to exercise	Insulin pump	-
Reduction of insulin basal rate 40 minutes prior to exercise	Exercise 2	-
Reduction of insulin basal rate 90 minutes prior to exercise	Dexcom G4 Platinum	-

Primary Outcome Measures

Name	Time	Method
Decrease in glucose levels	60 minutes (exercise period)	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

Secondary Outcome Measures

Name	Time	Method
Area under the curve of glucose levels < 4 mmol/L	From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent between 4 and 10 mmol/L	From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent < 4 mmol/L	From the end of exercise period to 6:00 next morning (11 hours)
Total amount of carbohydrates needed to treat hypoglycemic events	From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent below 4 mmol/L	60 minutes (exercise period)
Percentage of time of glucose levels spent between 4-10 mmol/L	60 minutes (exercise period)
Muscle blood flow	60 minutes (exercise period)
Decremental area under the curve of glucose levels	60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L	60 minutes (exercise period)
Number of patients with an exercise-induced hypoglycemia < 3.5 mmol/L	60 minutes (exercise period)
Number of patients requiring an oral treatment for hypoglycemia	From the end of exercise period to 6:00 next morning (11 hours)
Total number of hypoglycemia episodes requiring treatment	From the end of exercise period to 6:00 next morning (11 hours)
Percentage of time of glucose levels spent > 10 mmol/L	From the end of exercise period to 6:00 next morning (11 hours)
Mean time (minutes) to the first hypoglycemic event	60 minutes (exercise period)
Amount of carbohydrates needed to treat a hypoglycemic event	60 minutes (exercise period)

Trial Locations

Locations (2)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

Institut de recherches cliniques de Montréal; 🇨🇦 Montréal, Quebec, Canada