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The Feasibility of Personalized Hypoglycemia Outpatient Treatment for People Living With Type 2 Diabetes Mellitus
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.
The two study interventions that the participant can choose to complete (one or both interventions): Study intervention A: Ride a recumbent exercise bike at participant's own desired speed, until onset of capillary blood glucose showing mild low blood glucose (hypoglycemia). Study intervention B: Delay food intake after the participant brings and takes their routine clinical care prescribed medication(s) that decrease the blood glucose level. The participant brings in their medication(s) including sulfonylurea or insulin(s) as applicable to the study visit. In front of the study nurse, the participant takes these medication(s) at the same dose or reduced dose as defined in the study protocol. The participant is monitored until capillary blood glucose reaches the mild low blood glucose (hypoglycemia) level of 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The Ottawa Hospital
Ottawa, Ontario, Canada
Start Date
July 21, 2025
Primary Completion Date
December 31, 2026
Completion Date
June 30, 2027
Last Updated
July 30, 2025
120
ESTIMATED participants
Recumbent Exercise Bike to induce mild hypoglycemia
BEHAVIORAL
Delaying food to induce mild hypoglycemia,
BEHAVIORAL
Lead Sponsor
Ottawa Hospital Research Institute
NCT07064486
NCT07144670
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05974020