Springfield Clinic | Clinical Research Department
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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.
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Inclusion criteria
Exclusion criteria
Subject is critically ill or hospitalized
Prior use of CGM defined as:
Subject has a known contraindication to dexamethasone or dexamethasone acetate
Subjects requiring intravenous mannitol or mannitol irrigation solutions
Subject is on dialysis at the time of enrollment
Female subjects who are pregnant, planning on becoming pregnant or nursing
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Interventional model
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925 participants in 1 patient group
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Central trial contact
Katherine Tweden, PhD; Kathleen Davis
Data sourced from clinicaltrials.gov
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