Post Approval Study of the Eversense® Continuous Glucose Monitoring (PAS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03908125 |
Recruitment Status :
Recruiting
First Posted : April 9, 2019
Last Update Posted : July 29, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 | Device: Eversense® CGM system | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System |
Actual Study Start Date : | March 19, 2019 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | March 2023 |

Arm | Intervention/treatment |
---|---|
Continuous Glucose Monitoring Device |
Device: Eversense® CGM system
Continuous Glucose monitoring device that lasts up to 90 days |
- Incidence of procedure-related adverse events [ Time Frame: 12 months ]The primary safety endpoint is the Incidence of the composite of infection, secondary procedures to remove the sensor, or procedure-related adverse events of at least moderate severity
- Time in Range [ Time Frame: 12 months ]The primary effectiveness endpoint is Time in Range, which is defined as glucose values between 70mg/dL and 180 mg/dL, at 12 months post first sensor insertion compared to first month post first sensor insertion

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject has diabetes
- Subject is greater than 18 years of age
Exclusion Criteria:
- Subject is critically ill or hospitalized
- Subject has a known contraindication to dexamethasone or dexamethasone acetate
- Subjects requiring intravenous mannitol or mannitol irrigation solutions
- Female subjects who are pregnant, planning on becoming pregnant or nursing
- Subjects on hybrid closed loop systems or closed loop systems
- Subjects on other CGM systems

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908125
Contact: Katherine Tweden, PhD | 2406242602 | Katherine.tweden@senseonics.com | |
Contact: Maggie Lewis | maggies.lewis@senseonics.com |
United States, California | |
Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center | Recruiting |
Newport Beach, California, United States, 92663 | |
Contact: Valerie Wolf 949-764-8065 valerie.wolf@hoag.org | |
Principal Investigator: David Ahn, MD | |
United States, Colorado | |
Denver Endocrinology, Diabetes & Thyroid Center | Active, not recruiting |
Englewood, Colorado, United States, 80113 | |
United States, Florida | |
The Center for Diabetes and Endocrine Care | Active, not recruiting |
Fort Lauderdale, Florida, United States, 33312 | |
United States, Maryland | |
MODEL Clinical research | Recruiting |
Baltimore, Maryland, United States, 21204 | |
Contact: Karen Klein 410-828-7417 ext 119 | |
Principal Investigator: Phil Levin, MD | |
United States, Michigan | |
Metro Detroit Endocrinology Center | Active, not recruiting |
Dearborn, Michigan, United States, 48126 | |
United States, Missouri | |
Diabetes and Endocrinology Specialists, Inc. | Recruiting |
Chesterfield, Missouri, United States, 63017 | |
Contact: Suzette Christopher 314-469-6224 ext 226 | |
Principal Investigator: Ralph Oiknine, MD | |
United States, New York | |
Albany Medical College | Recruiting |
Albany, New York, United States, 12206 | |
Contact: Kevin Feisthamel feisthk@amc.edu | |
Principal Investigator: Robert Busch | |
United States, North Carolina | |
Physicians East | Recruiting |
Greenville, North Carolina, United States, 27834 | |
Contact: Kirsten Taylor 252-413-6299 Ktaylor@physicianseast.com | |
Principal Investigator: Mark Warren, MD | |
Wilmington Health/PMG | Recruiting |
Wilmington, North Carolina, United States, 28401 | |
Contact: Brittany Hayes Savoca bhayes@pmg-research.com | |
Principal Investigator: Michael Favorito, MD | |
United States, Pennsylvania | |
Diabetes & Endocrinology Consultants of Pennsylvania, LLC | Recruiting |
Feasterville, Pennsylvania, United States, 19053 | |
Contact: Nancy Ward 215-953-6804 | |
Principal Investigator: Alan Schorr, DO | |
United States, Tennessee | |
AM Diabetes & Endocrinology | Active, not recruiting |
Bartlett, Tennessee, United States, 38133 | |
United States, Texas | |
Texas Diabetes and Endocrinology | Active, not recruiting |
Austin, Texas, United States, 78731 | |
Javara, Inc. | Recruiting |
Houston, Texas, United States, 77095 | |
Contact: Tegan Mead 346-235-0311 | |
Principal Investigator: Rakesh Patel, MD | |
Diabetes and Glandular Disease Clinic | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Terri Ryan terri.ryan@dgdclinic.com | |
Principal Investigator: Mark Kipnes, MD | |
Consano Clinical Research, Diabetes and Metabolism Specialists | Recruiting |
Shavano Park, Texas, United States, 78231 | |
Contact: Gregory Danet 210-896-7772 | |
Principal Investigator: Michelle Welch |
Responsible Party: | Senseonics, Inc. |
ClinicalTrials.gov Identifier: | NCT03908125 |
Other Study ID Numbers: |
CTP-0034 |
First Posted: | April 9, 2019 Key Record Dates |
Last Update Posted: | July 29, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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.: | Yes |
Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |