The study design is open-label in which neither investigator nor study participants will be blinded to study treatment. After 16-weeks, participants initially assigned to DSME alone will cross-over to receive the intervention FGM device, while those initially randomized to using a FGM will continue using their device for an additional 16 weeks (Phase 2).
DSME sessions for both groups will consist of four individual in-clinic sessions and two telephone sessions. Participants randomized to the Control arm will receive 6 DSME sessions matched to time and location of the Intervention group. Welcome to flash glucose monitoring With the FreeStyle Libre 2 system, which measures glucose levels in people aged 4 years and older with diabetes. Participants randomized to the Intervention arm will receive a FreeStyle Libre FGM System, 1 training session on its proper use, and 6 DSME sessions. In Phase 1, participants will be randomized at a 1:1 ratio, stratified by use of glucagon-like peptide-1 receptor agonist to receive either a flash glucose monitor (FGM) + diabetes self-management education (DSME) (Intervention arm) or to DSME alone (Control arm). The IMMEDIATE study is a two-phased, cross-over study. Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM CANADA PRO
Although the FreeStyle Libre Pro system is approved for use in Canada.
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