Recruiting

Hypoglycemia Treatments

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT07094529

Conditions

Type 2 Diabetes (T2DM)

Hypoglycemia (Diabetic)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Recumbent Exercise Bike to induce mild hypoglycemia

Delaying food to induce mild hypoglycemia,

Study Details

Brief 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.

Conditions

Type 2 Diabetes (T2DM)

Hypoglycemia (Diabetic)

Study ID

NCT07094529

Start date

Jul 21, 2025

Status verified date

Jul, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

1. Consent provided
2. Age >= 18 years.
3. Diagnosed as type 2 diabetes mellitus.
4. 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 Criteria:

  • An individual who meets any of the following criteria will be excluded from participation in this study:

1. Diagnosed as another form of diabetes mellitus.
2. Has a history of hypoglycemia unawareness.
3. Had a hypoglycemia event, defined as capillary blood glucose < 3.9 mmol/L within 24 hours prior to the study visit booking time.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

Primary outcome measure

  • To determine feasibility to recruit an average of 8 patients per month at the study site (The Ottawa Hospital Diabetes clinics) for study protocol performance. [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Cathy Sun, MD MSc

613-738-8333csun@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 7W9

Contacts

Cathy Sun, MD MSc

613-738-8333csun@toh.ca

Principal Investigator:

Cathy Sun, MD MSc

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jul 30, 2025

Last verified

Jul, 2025

Keywords

  • hypoglycemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-07-30.