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

A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes
• Intervention / Treatment: Device: Blood glucose meter; Device: Eversense CGM System

• Study Type: Interventional
• Enrollment (Estimated): 925
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90057
      • LA Universal Research Center, Inc.
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Denver Endocrinology, Diabetes & Thyroid Center
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • CMR of Greater New Haven
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research
  • Florida
    • Fort Lauderdale, Florida, United States, 33312
      • The Center for Diabetes and Endocrine Care
    • Miami, Florida, United States, 33165
      • MedCare Research
    • Miami Lakes, Florida, United States, 33014
      • Miami Lakes Clinical Trials INC
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
  • Illinois
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • Maryland
    • Camp Springs, Maryland, United States, 20746
      • Southern Maryland Medical Group
  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Metro Detroit Endocrinology
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Diabetes and Endocinology Specialists, Inc.
  • New York
    • Long Island City, New York, United States, 11101
      • Endocrine Associates of West Village
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Physician's East Endocrinology
    • Smithfield, North Carolina, United States, 27577
      • Superior Clinical Research
  • Tennessee
    • Bartlett, Tennessee, United States, 38133
      • AM Diabetes & Endocrinology
  • Texas
    • Austin, Texas, United States, 78749
      • Texas Diabetes and Endocrinology
    • Dallas, Texas, United States, 75235
      • Southwest Family Medicine Associates
    • Houston, Texas, United States, 77095
      • Clinical Research Solution Institute
    • McAllen, Texas, United States, 78503
      • RGV Endocrine Center
  • Vermont
    • Rutland, Vermont, United States, 05701
      • Green Mountain Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self monitoring of blood glucose, then CGM System; 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	Device: Blood glucose meter; First phase: SMBG for 6 months; Device: Eversense CGM System; Second phase: CGM for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events	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	First 6 months (phase 1) compared to second 6 months (phase 2)

Collaborators and Investigators

• Sponsor: Senseonics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 13, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Type 1 Diabetes
• Other Study ID Numbers: CTP-0039

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No