Suspending Basal Insulin Levels for Exercise in Adults With Type 1 Diabetes
|ClinicalTrials.gov Identifier: NCT03034798|
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
|Condition or disease|
|Type1 Diabetes Mellitus Physical Activity Hypoglycemia|
Written informed consent will be collected on the first day during the familiarization session from all individuals that wish to participate. A researcher will provide a brief explanation on how the continuous glucose monitor (CGM) works (Medtronic Inc., Canada) during the first visit to the laboratory. They will also describe how the CGM sensor insertion process will occur for those participants who have not worn one in the past. The participant will clean and sanitize the area and insert the CGM superficially in the skin themselves and connect the transmitter device to the sensor. The CGM will be worn for a total of 7 days and then removed by the participant and returned to the researcher to be downloaded. The sports armband will also be placed on the left upper arm and be worn continuously for 7 days. The principal student investigator (PSI) or principal investigator (PI) will provide all participants with information about the sports armband and place it on the skin immediately following. This device simply sits on the surface of the skin, but has a specific placement and activation and must be applied by the PSI or PI. Finally, during exercise visits, the Zephyr bioharness will be connected just below chest level and around the rib cage. This device is sits on top of the skin simply like an elastic band around the rib cage. The bioharness will only be worn during exercise visits and disconnected at the end of each activity.
Blood glucose levels will be monitored frequently during exercise using a Contour Link glucometer (Bayer, Canada). Participants will use personal lancing device for finger pokes, but the investigators will provide the glucometer and test strips. Each blood sugar check will be recorded in the data binder along with carbohydrate intake, any changes in basal rate or pump settings, and food intake. If blood glucose levels reach 3.9 mmol/L or less, participants will be asked to stop activity immediately and consume fast-acting carbohydrates (i.e. Dextrose tablets (Dex4, USA)). 15-minutes after ingestion of carbohydrates, blood glucose will be tested again before allowing the individual to return to activity safely. On the last day of testing, participants will be asked to return the CGM, sports armband, and bioharness to the research team. The data will later be uploaded and analyzed.
Patients will undergo a fitness assessment (maximal aerobic capacity) during visit 1 and perform 40-minutes of continuous (treadmill jogging) and 40-minutes of intermittent (calisthenics) high-intensity type exercises (visit 2 and 3). Upon entry to the laboratory, participants will be asked to check blood glucose levels using the glucometer provided. The first exercise session will consist of a 40-minute treadmill walk/jog at ~40-50% of VO2max. The second exercise session will include various aerobic and anaerobic activities including push-ups, plank, jumping jacks, high knees, etc. Regular finger capillary blood samples will be collected every 10-minutes during exercise. Once the exercise session is complete, participants will be asked to remain in the laboratory for 30-minutes for additional blood glucose measurements and to ensure hypoglycemic episodes do not occur post-exercise. Participants will be given the contour link glucometer to monitor glucose levels throughout the evening and night.
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||The Effects of Basal Insulin Suspension at the Start of Exercise on Blood Glucose Levels During Continuous vs. Circuit-based Exercise in Individuals With Type 1 Diabetes on CSII|
|Actual Study Start Date :||January 14, 2015|
|Actual Primary Completion Date :||July 28, 2016|
|Actual Study Completion Date :||July 28, 2016|
Type 1 Diabetes Exercisers
Participants performed 2 different forms of exercise of identical duration and similar total energy expenditure. One form was purely aerobic in nature and the other was intermittent, high-intensity exercise.
- Blood glucose concentrations [ Time Frame: Approximately 2 hours ]Whole blood glucose concentrations were measured using a handheld glucometer every 10-minutes before, during, and after both exercise conditions.
- Participants estimated blood glucose concentration [ Time Frame: 40-minutes during exercise and 10-minutes post-exercise ]Whole blood glucose concentrations were measured using a handheld glucometer and the values were blinded from participants during exercise. Participants were asked to estimate the change in glycemia every 10-minutes and actual measured blood glucose was revealed to participants post-exercise.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034798
|Principal Investigator:||Michael C Riddell, PhD||York University|