Personalized outpatient hypoglycemia treatment

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

This test tries whether adults with type 2 diabetes can safely treat mild low blood sugar by choosing how much quick carbohydrate to take and when to recheck their fingerstick.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT07094529 on ClinicalTrials.gov

What this trial studies

In this outpatient feasibility protocol at The Ottawa Hospital, adults with type 2 diabetes on insulin or sulfonylureas undergo supervised induction of mild hypoglycemia (capillary glucose 3.0–3.8 mmol/L) using either recumbent cycling or delayed food after taking their usual glucose-lowering medication. Participants choose one of four carbohydrate treatment doses (8, 16, 20, or 32 grams) and one of four recheck intervals (15, 20, 25, or 30 minutes) to test their preferred approach. Study staff monitor glucose and symptoms during and after the intervention to document glucose recovery and safety. The design is single-center and open-label, with participants able to complete one or both induction methods under nursing supervision.

Who should consider this trial

Good fit: Adults (≥18) with type 2 diabetes who have been taking insulin or a sulfonylurea for at least one month and who can give consent and attend an in-person visit are the intended participants.

Not a fit: People with other types of diabetes, with hypoglycemia unawareness, or who had a low blood sugar event within 24 hours before the visit are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could help personalize simple hypoglycemia treatment guidance so people avoid under- or overtreating mild low blood sugar.

How similar studies have performed: Guidelines and prior studies commonly recommend ~15–20 g of fast-acting carbohydrate and a ~15-minute recheck, but testing selectable carbohydrate doses and recheck timings in a supervised outpatient induction is relatively novel.

Eligibility criteria

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.

Where this trial is running

Ottawa, Ontario

• The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Cathy Sun, MD MSc — Ottawa Hospital Research Institute
• Study coordinator: Cathy Sun, MD MSc

Conditions Type 2 Diabetes; Hypoglycemia; hypoglycemia