A Phase 2 interventional study of 60-minute exercise and Insulin pump in Type 1 Diabetes, sponsored by Institut de Recherches Cliniques de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Institut de Recherches Cliniques de Montreal · Phase 2, Interventional, and Treatment
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas 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. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 37 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Institut de Recherches Cliniques de Montreal is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
Other: 60-minute exercise · Device: Insulin pump · Device: Dexcom G4 Platinum glucose sensor · Drug: Insulin · Other: Single-hormone closed-loop strategy
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
Other: 60-minute exercise · Device: Insulin pump · Device: Dexcom G4 Platinum glucose sensor · Drug: Insulin · Other: Single-hormone closed-loop strategy
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
Other: 60-minute exercise · Device: Insulin pump · Device: Dexcom G4 Platinum glucose sensor · Drug: Insulin · Other: Single-hormone closed-loop strategy
Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.
Patient's usual fast-acting insulin analog will be used.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Time frame: From 9:30 to 11:30 (120 minutes)
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
Time frame: From 8:00 to 10:50 (170 minutes)
Number of patients experiencing exercise-induced hypoglycemia requiring treatment
Time frame: From 9:30 to 10:30 (60 minutes)
Decremental area under the curve from the start of the exercise
Time frame: From 9:30 to 11:00 (90 minutes)
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
Time frame: From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent below 3.3 mmol/L
Time frame: From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent below 2.8 mmol/L
Time frame: From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent above 10 mmol/L
Time frame: From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent above 13.9 mmol/L
Time frame: From 9:30 to 10:30 (60 minutes)
Percentage of time of plasma glucose levels spent above 16.7 mmol/L
Time frame: From 9:30 to 10:30 (60 minutes)
Mean plasma glucose levels
Time frame: From 8:00 to 11:30 (210 minutes)
Standard deviation of glucose levels
Time frame: From 8:00 to 11:30 (210 minutes)
Coefficient of variation of glucose levels
Time frame: From 8:00 to 11:30 (210 minutes)
Mean time (minutes) to the first hypoglycemic event
Time frame: From 9:30 to 10:30 (60 minutes)
Plan to share: Undecided
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut de Recherches Cliniques de Montreal