Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study
Recruiting · NCT07094529 · Interventional (participants receive a specific treatment) · Lead sponsor: Ottawa Hospital Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Delaying food to induce mild hypoglycemia,Recumbent Exercise Bike to induce mild hypoglycemia
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Consent provided
- Age \>= 18 years.
- Diagnosed as type 2 diabetes mellitus.
- 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:
- Diagnosed as another form of diabetes mellitus.
- Has a history of hypoglycemia unawareness.
- Had a hypoglycemia event, defined as capillary blood glucose \< 3.9 mmol/L within 24 hours prior to the study visit booking time.
Where it is running
1 location listed.
- The Ottawa Hospital - Ottawa, Ontario, Canada