RecruitingNot ApplicableNCT07094529

Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study

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

Sponsor

Ottawa Hospital Research Institute

Enrollment

120 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes (T2DM)Hypoglycemia (Diabetic)

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

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria4

An individual who meets any of the following criteria will be excluded from participation in this study:
Diagnosed as another form of diabetes mellitus.
Has a history of hypoglycemia unawareness.
Had a hypoglycemia event, defined as capillary blood glucose \< 3.9 mmol/L within 24 hours prior to the study visit booking time.

Interventions

BEHAVIORALRecumbent 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.

BEHAVIORALDelaying 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.