Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07094529

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

Led by Ottawa Hospital Research Institute · Updated on 2025-07-30

120

Participants Needed

1

Research Sites

25 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study personalized outpatient treatments for mild low blood sugar (hypoglycemia) in people living with type 2 diabetes. The trial evaluates two interventions designed to induce mild hypoglycemia, allowing participants to choose their preferred treatment and timing for blood sugar rechecks. It focuses on the feasibility of recruiting participants and understanding how personalized treatment choices affect hypoglycemia resolution. Participants can choose one or both interventions. The first involves riding a recumbent exercise bike at their desired speed until mild hypoglycemia develops, defined by a blood glucose level between 3.0 and 3.8 mmol/L. The second involves delaying food intake after taking their prescribed diabetes medications (sulfonylurea or insulin) under nurse supervision until mild hypoglycemia occurs. After hypoglycemia onset, participants select one of four carbohydrate treatment amounts (8, 16, 20, or 32 grams) and one of four blood glucose recheck times (15, 20, 25, or 30 minutes). During the study visit, participants will be monitored closely while exercising or after medication intake to detect mild hypoglycemia. Data on distance traveled on the bike and blood glucose levels will be recorded. Researchers will track feasibility of recruitment over 12 months and assess how well personalized treatment choices resolve hypoglycemia. The trial involves multiple visits with blood glucose testing and monitoring, with participant safety carefully observed throughout the study period.

CONDITIONS

Brief Title

Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consent provided
  • Age 18 years or older
  • Diagnosed with type 2 diabetes mellitus
  • Using sulfonylurea or insulin medication for at least one month prior to the study
Not Eligible

You will not qualify if you...

  • Diagnosed with any form of diabetes other than type 2
  • History of hypoglycemia unawareness
  • Had a hypoglycemia event (blood glucose below 3.9 mmol/L) within 24 hours before the study visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - Single study visits per intervention

Participants complete one or both study interventions: riding a recumbent exercise bike until mild hypoglycemia occurs or delaying food intake after taking their usual medication under nurse supervision until mild hypoglycemia occurs. Participants choose their carbohydrate treatment amount and blood glucose recheck time based on personal preference.

1 visit (in-person) per chosen intervention

Trial Site Locations

Total: 1 location

1

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 7W9

Actively Recruiting

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Research Team

C

Cathy Sun, MD MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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