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

April 11, 2024 updated by: Senseonics, Inc.

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

925

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90057
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Denver Endocrinology, Diabetes & Thyroid Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lori Gerard, MD
        • Sub-Investigator:
          • Linda Buckley, MD
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Recruiting
        • CMR of Greater New Haven
        • Contact:
        • Principal Investigator:
          • Joseph Soufer, MD
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Chase Medical Research
        • Principal Investigator:
          • Joseph Soufer, MD
        • Contact:
    • Florida
      • Fort Lauderdale, Florida, United States, 33312
      • Miami, Florida, United States, 33165
        • Recruiting
        • MedCare Research
        • Contact:
        • Principal Investigator:
          • Adalberto Aguilera, MD
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Miami Lakes Clinical Trials INC
        • Contact:
        • Principal Investigator:
          • Barry M Kotler, MD
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Atlanta Diabetes Associates
        • Contact:
        • Principal Investigator:
          • Bruce Bode, MD
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Rocky Mountain Clinical Research
        • Contact:
        • Principal Investigator:
          • David Liljenquist, MD
    • Illinois
      • Springfield, Illinois, United States, 62702
    • Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Withdrawn
        • MODEL Clinical Research
      • Camp Springs, Maryland, United States, 20746
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Metro Detroit Endocrinology
        • Contact:
        • Principal Investigator:
          • Ayman Elkadry, MD
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • Diabetes and Endocinology Specialists, Inc.
        • Contact:
          • Suzette Christopher, CRC
          • Phone Number: 226 314-469-6224
          • Email: metabnet@aol.com
        • Principal Investigator:
          • Ralph Oiknine, MD
    • New York
      • Long Island City, New York, United States, 11101
        • Recruiting
        • Endocrine Associates of West Village
        • Principal Investigator:
          • Anastasios Manessis
        • Contact:
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Physician's East Endocrinology
        • Principal Investigator:
          • Mark Warren, MD
        • Contact:
      • Smithfield, North Carolina, United States, 27577
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • Recruiting
        • AM Diabetes & Endocrinology
        • Principal Investigator:
          • Kashif Latif, MD
        • Contact:
        • Contact:
    • Texas
      • Austin, Texas, United States, 78749
        • Recruiting
        • Texas Diabetes and Endocrinology
        • Principal Investigator:
          • Jean Chen, MD
        • Contact:
        • Contact:
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Southwest Family Medicine Associates
        • Contact:
        • Principal Investigator:
          • Chrisette Dharma, MD
      • Houston, Texas, United States, 77095
        • Withdrawn
        • Javara, Inc
      • Houston, Texas, United States, 77095
        • Recruiting
        • Clinical Research Solution Institute
        • Principal Investigator:
          • Rakesh Patel, MD
        • Contact:
      • McAllen, Texas, United States, 78503
        • Recruiting
        • RGV Endocrine Center
        • Contact:
        • Principal Investigator:
          • Gloria Ortiz
        • Sub-Investigator:
          • Claudia Maldanado
    • Vermont
      • Rutland, Vermont, United States, 05701
        • Recruiting
        • Green Mountain Research Institute
        • Contact:
        • Principal Investigator:
          • Hurtado, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
First 6 months (phase 1) compared to second 6 months (phase 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senseonics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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