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

Plain Language Summary

Simplified for easier understanding

This study is testing whether a personalized approach to managing low blood sugar (hypoglycemia) in people with type 2 diabetes — using outpatient guidance rather than a hospital visit — is practical and effective. The focus is on people who take sulfonylureas or insulin, which are medications that can cause blood sugar to drop too low. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with type 2 diabetes - You have been taking a sulfonylurea (e.g., glipizide, glyburide) or any type of insulin for at least one month **You may NOT be eligible if...** - You have a different type of diabetes (e.g., type 1 diabetes) - You have a history of not being aware when your blood sugar drops too low (hypoglycemia unawareness) - You had a low blood sugar event (blood glucose below 3.9 mmol/L) within the past 24 hours before your scheduled study visit Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.