Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas
Brief summary
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise. The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.
Detailed description
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon. We aim to conduct a randomized two-way cross-over trial comparing single-hormone closed-loop strategy and dual-hormone closed-loop strategy to compare the two interventions during exercise periods in adults with type 1 diabetes. A moderate intensity exercise will be performed for 60 minutes at 60% of the maximum oxygen consumption (VO2max). A high intensity exercise will be 40 minutes of interval training. The interval training will be preceded by a 10 minutes warm-up and followed by a 10 minutes cool down.
Interventions
OTHER60-minute exercise
Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max. Patients will be discharged at 20:00.
OTHER40-minute interval exercise
Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 40-minute interval exercise. Patients will be discharged at 20:00.
Sponsors
Société Francophone du Diabète
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females ≥ 18 years of old. * Clinical diagnosis of type 1 diabetes for at least one year. * The subject will have been on insulin pump therapy for at least 3 months. * Last (less than 3 months) HbA1c ≤ 12%.
Exclusion criteria
* Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator. * Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery. * Ongoing pregnancy. * Severe hypoglycemic episode within two weeks of screening. * 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). * Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc). * Problems with venous access
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients experiencing exercise-induced hypoglycemia requiring dextrose infusion (< 3.3 mmol/L symptomatic or < 3.0 mmol/L regardless of symptoms). | 18:00 hours to 19:30 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve of plasma glucose levels < 4 mmol/L | 15:30 hours to 19:30 hours | — |
| Percentage of time of plasma glucose levels < 4 mmol/L | 15:30 hours to 19:30 hours | — |
| Number of patients with an exercise-induced hypoglycemia < 3.9 mmol/L | 15:30 hours to 19:30 hours | — |
| Decrease in glucose levels during each exercise | 18:00 to 19:30 hours or 18:00 to 19:10 depending on the exercise performed | Difference between glucose levels at the beginning of the exercise and the lowest glucose level from the start of the exercise until 30 minutes after exercise). |
| Percentage of time-in-target defined as between 4 and 10 mmol/L | 15:30 hours to 19:30 hours | — |
| Mean time (minutes) to the first hypoglycemic event during the exercise period | 18:00 to 19:00 | — |
| The amount of dextrose infused | 15:30 to 19:30 | — |
| Decremental area under the curve from the start of the exercise for 90 minutes. | 18:00 to 19:30 | — |
Countries
Canada
Outcome results
None listed