Patients in each setting will be randomized to one of two groups: 1) FGM using the Libre 1 flash glucose monitor (intervention) for six months followed by usual capillary blood glucose monitoring four times per day (current local standard of care) for six months; or 2) Capillary blood glucose monitoring four times per day first (current local standard of care), followed by FGM using the Libre 1 flash glucose monitor (intervention) for six months (Figure 2). Each patient will serve as their own control. During intervention treatment periods, participants will be required to scan their sensor at least pre and post meals, before bed and upon waking, and occasionally during the night. They should 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 to ensure all data is captured overnight.

            Both groups will receive intensive in-person or virtual group education about flash and capillary blood glucose monitoring at 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-minute in-person or virtual study visit at one month to assess how they have adapted to the FGM device and answer any questions. They will be asked to attend for approximately 30-minute in-person follow-up visits at three and six months.

After the 12 months follow up period (6 months intervention and cross over), all patients will enter a 6-month observation period during which they will be offered the opportunity to again use FGM (the Libre 1 flash glucose monitor) if they desire. Any insulin adjustments and dietary re-education or adjustment based on review will be undertaken as per local standard of care.