Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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