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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Recumbent Exercise Bike to induce mild hypoglycemia
BehavioralThe participant rides the recumbent exercise bike at their preferred speed and records the distance travelled until there is onset of mild hypoglycemia, determined by capillary blood glucose test result 3.0 to 3.8 mmmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.
Delaying food to induce mild hypoglycemia,
BehavioralAt the study visit, in front of the study nurse, the participant takes their usual clinical care dose of sulfonylurea or basal insulin. If the participant's usual clinical care includes insulin with a rapid-acting component, then its dose is reduced based on the study protocol. No food intake (water is allowed) until there is onset of mild hypoglycemia, determined by a capillary blood glucose test result 3.0 to 3.8 mmol/L. Based on each participant's own experience with hypoglycemia treatment or their preferences, the participant can choose one of 4 simple carbohydrate treatment quantities: 8 grams, 16 grams, 20 grams, 32 grams The participant can choose one of 4 capillary blood glucose recheck times: 15 minutes, 20 minutes, 25 minutes, 30 minutes.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Recumbent Exercise Bike to induce mild hypoglycemiaExperimental treatment 1 intervention
Group B: Delaying food to induce mild hypoglycemiaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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.
Average number of patients recruited per month is determined by 60 patients (the target recruitment number) for each study intervention, divided by the number of months that it took to complete the recruitment.
Time frame
12 monthsSecondary outcomes
1
To assess the percentage hypoglycemia resolution for people living with type 2 diabetes based on their personalized choice of treatment and first recheck time.
Percentage hypoglycemia resolution with respect to grams of simple carbohydrates that participant chose, and first recheck time that participant preferred.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov