NCT07094529

Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study

The Feasibility of Personalized Hypoglycemia Outpatient Treatment for People Living With Type 2 Diabetes Mellitus

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The two study interventions that the participant can choose to complete (one or both interventions): Study intervention A: Ride a recumbent exercise bike at participant's own desired speed, until onset of capillary blood glucose showing mild low blood glucose (hypoglycemia). Study intervention B: Delay food intake after the participant brings and takes their routine clinical care prescribed medication(s) that decrease the blood glucose level. The participant brings in their medication(s) including sulfonylurea or insulin(s) as applicable to the study visit. In front of the study nurse, the participant takes these medication(s) at the same dose or reduced dose as defined in the study protocol. The participant is monitored until capillary blood glucose reaches the mild low blood glucose (hypoglycemia) level of 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.

Conditions

• Type 2 Diabetes (T2DM)
• Hypoglycemia (Diabetic)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-21
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: Canada