Comparison of Flash Glucose Monitoring and Capillary Blood Glucose monitoring in children and youth with Type 1 diabetes in India

Patients ineach setting will be randomized to one of two groups: 1) FGM using the Libre 1 flashglucose monitor (intervention) for six months followed by usual capillary bloodglucose monitoring four times per day (current local standard of care) for sixmonths; or 2) Capillary blood glucose monitoring four times per day first (currentlocal standard of care), followed by FGM using the Libre 1 flash glucosemonitor (intervention) for six months (Figure 2). Each patient will serve astheir own control. During intervention treatmentperiods, participants will be required to scan their sensor at least pre andpost meals, before bed and upon waking, and occasionally during the night. Theyshould be educated not to wait longer than 8 hours between scans (overnight).Parents should be advised to scan their child’s Libre before they go to bed toensure all data is captured overnight.

Both groups will receive intensive in-personor virtual group education about flash and capillary blood glucose monitoringat the time of enrolment and at the time of crossover. During intervention treatment periods, patients(with parent/guardian as appropriate) will have approximately one 30-minutein-person or virtual study visit at one month to assess how they have adaptedto the FGM device and answer any questions. They will be asked to attend for approximately30-minute in-person follow-up visits at three and six months.

After the 12 months follow up period (6 monthsintervention and cross over), all patients will enter a 6-month observationperiod during which they will be offered the opportunity to again use FGM (the Libre1 flash glucose monitor) if they desire. Any insulin adjustments and dietary re-education or adjustmentbased on review will be undertaken as per local standard of care.