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. 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 FreeStyle Libre flash glucose monitoring system is indicated for measuring interstitial fluid glucose levels in adults aged 18 years and older with diabetes mellitus. The IMMEDIATE study is a two-phased, cross-over study. This site is intended for Canadian Healthcare Professionals only.
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