Personalized Hypoglycemia Outpatient Treatment - a Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Recumbent Exercise Bike to induce mild hypoglycemia
- Delaying food to induce mild hypoglycemia,
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov