180
Participants
Start Date
August 15, 2022
Primary Completion Date
August 15, 2027
Study Completion Date
August 15, 2027
Libre 2
"The unblinded FreeStyle Libre 2 CGM will be placed every two weeks during months 0-12 for the CGM Cohort. Patients will be taught to insert the sensor themselves.~They will be given a 1 month supply at each monthly clinic visit and extra sensors in case a sensor falls out early. Patients will be given SMBG test strips to test capillary glucose for confirmation of any CGM glucose level \<=60mg/dl. They will keep track of the number of times this is necessary. Patients will return used sensors at each clinic visit. The study team will upload the data to a study website. Patients and care providers will have access to unblinded sensor data for clinical use."
Device for SMBG and Libre Pro
"A glucose meter and sufficient teststrips for fingerpoke glucose monitoring 3x/day will be provided for months 1-6. This is standard-of-care in Uganda. Glucose meters will be downloaded monthly in clinic as per usual clinical practice.~DeviceBlinded CGM device: Libre Pro (blinded data collection device, not an intervention) The blinded FreeStyle Libre Pro CGM will be inserted at each monthly clinic visit to provide control data, months 0-6 for the Control Group. They will return all used sensors at each clinic visit. The study team will upload the data to a study website. Neither patients nor the local research teams will have access to the blinded sensor data for clinical use until the end of months 0-6 so as not to influence standard diabetes management. They will instead rely on SMBG values as per usual routine.~After the first 6 months they will receive Libre 2 CGM systems as described above for the intervention group."
RECRUITING
University of Minnesota, Minneapolis
University of Minnesota
OTHER