Eversense® Non-adjunctive Use Post Approval Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood glucose meter: First phase: SMBG for 6 months

Eversense CGM System: Second phase: CGM for 6 months

Study summary

This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.

Eligibility

Primary outcome measure(s)

• Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events — First 6 months (phase 1) compared to second 6 months (phase 2)
  Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events with SMBG use for 6 months compared to Eversense CGM system used non-adjunctively for 6 months

Trial sites (23)

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