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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:

‣ Consent provided

⁃ Age \>= 18 years.

⁃ Diagnosed as type 2 diabetes mellitus.

⁃ Type 2 diabetes medications include at least one of the following for at least one month prior to entering the study: sulfonylurea or insulin of any type.

Locations
Other Locations
Canada
The Ottawa Hospital
RECRUITING
Ottawa
Contact Information
Primary
Cathy Sun, MD MSc
csun@toh.ca
613-738-8333
Time Frame
Start Date: 2025-07-21
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 120
Treatments
Experimental: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov