To investigate the effect of intermittent-scanning CGM (isCGM) together with structured education focused on the utilization of the trend arrow to prevent hypoglycemia in patients with type 1 diabetes mellitus, we planned a crossover study comparing FreeStyle Libre and self-monitoring of blood glucose (SMBG).
The ISCHIA study is a multicenter, prospective, open-label, randomized crossover study of patients with type 1 diabetes mellitus to compare isCGM and SMBG. The Intervention arm uses isCGM together with structured education to prevent hypoglycemia and SMBG 3 times a day or more. The control arm uses SMBG 3 times a day or more and retrospective CGM whose results are masked for the study participants. The study includes 28-day run-in period, 84-days sequence 1, 28-day washout period, and 84-day sequence 2. Participants were randomly assigned to Group A (Intervention/ Control) or Group B (Control / Intervention) in a 1:1 ratio. The primary endpoint is the time spent in hypoglycemia (<70 mg/ dL) per day (hour/day) between the Intervention arm and Control arm. The secondary endpoints include other CGM metrics, the quality of life (QOL), patients’ adherence and cost-effectiveness.
The study was launched on March 15, 2019 at 8 institutes.
This study will be the first randomized crossover study of patients with type 1 diabetes mellitus evaluating the effect of the usage of isCGM together with structured education to prevent hypoglycemia in Japan. (jRCT: jRCT1052180075)