Eversense® Non-adjunctive Use Post Approval Study (NA-PAS)

Senseonics

Status: Enrolling

Conditions: Diabetes

Treatments: Device: Blood glucose meter; Device: Eversense CGM System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04836546

CTP-0039

Details and patient eligibility

About

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.

Enrollment: 925 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has diabetes
2. Subject is ≥18 years of age
3. Subject has a smartphone that is internet enabled
4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
5. Subjects is willing and able to provide written signed and dated informed consent

Exclusion criteria

1. Subject is critically ill or hospitalized

2. Prior use of CGM defined as:

   • No more than 1 week of continuous CGM use in the last 6 months, and
   • At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.

3. Subject has a known contraindication to dexamethasone or dexamethasone acetate

4. Subjects requiring intravenous mannitol or mannitol irrigation solutions

5. Subject is on dialysis at the time of enrollment

6. Female subjects who are pregnant, planning on becoming pregnant or nursing

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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925 participants in 1 patient group

Self monitoring of blood glucose, then CGM System

Experimental group

Description:

All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months

Treatment:

Device: Eversense CGM System

Device: Blood glucose meter