Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study (NCT07094529) | Clinical Trial Compass
RecruitingNot Applicable
Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study
Canada120 participantsStarted 2025-07-21
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To determine feasibility to recruit an average of 8 patients per month at the study site (The Ottawa Hospital Diabetes clinics) for study protocol performance.