Type 1 Diabetes Mellitus
Conditions
Keywords
Type 1 diabetes, Exercise, Hypoglycemia, Insulin pump
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.
Interventions
OTHERExercise 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.
OTHERExercise 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.
DEVICEDexcom G4 Platinum
The Dexcom G4 Platinum will be used to measure continuous glucose levels.
DRUGInsulin
Participant's usual fast-acting insulin analog will be used.
DEVICEInsulin pump
Participant's insulin pump will be used to infuse insulin.
Sponsors
Institut de Recherches Cliniques de Montreal
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Percentage of time of glucose levels spent between 4 and 10 mmol/L | 4 hours following end of exercise |
| Percentage of time of glucose levels spent < 4 mmol/L | 4 hours following end of exercise |
| Percentage of time of glucose levels spent below 4 mmol/L | 60 minutes (exercise period) |
| Decremental area under the curve of glucose levels | 60 minutes (exercise period) |
| Area under the curve of glucose levels < 4 mmol/L | 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 | 60 minutes (exercise period) |
| Total number of hypoglycemia episodes requiring treatment | 60 minutes (exercise period) |
| Percentage of time of glucose levels spent > 10 mmol/L | 60 minutes (exercise period) |
| Percentage of time of glucose levels spent between 4-10 mmol/L | 60 minutes (exercise period) |
| 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) |
| Muscle blood flow | 60 minutes (exercise period) |
| Total amount of carbohydrates needed to treat hypoglycemic events | 4 hours following end of exercise |
Countries
Canada
Contacts
Primary ContactSemah Tagougui
Backup ContactVirginie Messier
Outcome results
None listed