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Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study
Sponsor: Ottawa Hospital Research Institute
Summary
This study will offer two study interventions designed to bring on a mild low blood sugar (capillary blood glucose result 3.0 to 3.8 mmol/L), in order to study the effectiveness of each study participant's personal choice of treatment and first recheck time. The two study interventions that the participant can choose to complete (one or both interventions). Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities, and choose one of 4 capillary blood glucose recheck times.
Official title: The Feasibility of Personalized Hypoglycemia Outpatient Treatment for People Living With Type 2 Diabetes Mellitus
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-07-21
Completion Date
2027-06-30
Last Updated
2025-07-30
Healthy Volunteers
No
Interventions
Recumbent Exercise Bike to induce mild hypoglycemia
The participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia, determined by capillary blood glucose test result 3.0 to 3.8 mmmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.
Delaying food to induce mild hypoglycemia,
At the study visit, in front of the study nurse, the participant takes their usual clinical care dose of sulfonylurea or basal insulin. If the participant's usual clinical care includes insulin with a rapid-acting component, then its dose is reduced based on the study protocol. No food intake (water is allowed) until there is onset of mild hypoglycemia, determined by a capillary blood glucose test result 3.0 to 3.8 mmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.
Locations (1)
The Ottawa Hospital
Ottawa, Ontario, Canada