Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study (PHOT)

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Type 2 Diabetes (T2DM); Hypoglycemia (Diabetic)

Treatments: Behavioral: Recumbent Exercise Bike to induce mild hypoglycemia; Behavioral: Delaying food to induce mild hypoglycemia,

Study type: Interventional

Funder types: Other

Identifiers

NCT07094529

20250297-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Recumbent Exercise Bike to induce mild hypoglycemia

Experimental group

Description:

The participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia.

Treatment:

Behavioral: Recumbent Exercise Bike to induce mild hypoglycemia

Delaying food to induce mild hypoglycemia

Experimental group

Description:

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.

Treatment:

Behavioral: Delaying food to induce mild hypoglycemia,