Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

July 21, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

June 30, 2027

Conditions
Type 2 Diabetes (T2DM)Hypoglycemia (Diabetic)
Interventions
BEHAVIORAL

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."

BEHAVIORAL

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."

Trial Locations (1)

K1H 7W9

RECRUITING

The Ottawa Hospital, Ottawa

All Listed Sponsors
lead

Ottawa Hospital Research Institute

OTHER