Diabetes MellitusPASNCT03908125

Post Approval Study of the Eversense® Continuous Glucose Monitoring

A study testing Eversense® CGM System in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Senseonics, Inc. at 17 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What is being tested?: Eversense® CGM System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 273 participants
Where: 17 sitesUnited States
Study dates: 19 Mar 2019to 1 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has diabetes
Subject is greater than 18 years of age

Who cannot join

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

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Albany Medical College
Albany, New York, 12206
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
Texas Diabetes and Endocrinology
Austin, Texas, 78731
MODEL Clinical research
Baltimore, Maryland, 21204
AM Diabetes & Endocrinology
Bartlett, Tennessee, 38133
Diabetes and Endocrinology Specialists, Inc.
Chesterfield, Missouri, 63017
Clinical Research Solution, LLC
Cypress, Texas, 77433
Metro Detroit Endocrinology Center
Dearborn, Michigan, 48126
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, 80113
Diabetes & Endocrinology Consultants of Pennsylvania, LLC
Feasterville, Pennsylvania, 19053
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
Physicians East
Greenville, North Carolina, 27834
Javara, Inc
Houston, Texas, 77095
Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center
Newport Beach, California, 92663
Diabetes and Glandular Disease Clinic
San Antonio, Texas, 78229
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System

Read the detailed description

The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days.

The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PAS study will provide safety and effectiveness data up to 27 months of repeated use.

Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Being tested: Eversense® CGM System
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Eversense® CGM SystemDevice
Continuous Glucose monitoring device

Study groups in NCT03908125
Study group	Role	What they receive
Continuous Glucose Monitoring Device	Other	Commercial Continuous Glucose Monitoring Device Receives: Device: Eversense® CGM System

What is being measured

The primary outcome is the main question the study is designed to answer.

The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of < 4%.
Measured: up to 27 months
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.
Measured: Baseline and Month 12

Secondary outcomes (11)

The Additional Effectiveness Endpoint of Average Hours of Use Per Day
Measured: up to 27 months
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline
Measured: Baseline, Month 6, Month 12, Month 18, and Month 24
Patient Satisfaction With CGM System Use (CGM-SAT Scale)
CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM.
Measured: up to 27 months
Patient Reported Diabetes Distress Scale (DDS)
The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes.
Measured: Screening, Day 180, Day 360, and Day 720
Success Rate of Insertion Procedures: Overall and by HCP Experience
Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions.
Measured: up to 27 months
Success Rate of Removal Procedures: Overall and by HCP Experience
Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals.
Measured: up to 27 months
Rate of Insertion Procedures With Serious Adverse Events
Measured: up to 27 months
Rate of Removal Procedures With Serious Adverse Events
Measured: up to 27 months
HCP Feedback Questionnaire Regarding Insertion
The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.
Measured: up to 27 Months
HCP Feedback Questionnaire Regarding Removal
The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.
Measured: up to 27 Months
Residual Dexamethasone Level in Explanted Sensors
The residual dexamethasone (DXA) content in Sensors was analyzed after removal.
Measured: up to 27 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 20191 Feb 2024

First posted9 Apr 2019
Study start19 Mar 2019
Primary completion1 Feb 2024
Study completion1 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 273 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03908125
Sponsor's protocol ID: CTP-0034
Acronym: PAS
Status last verified: Mar 2025
First submitted: 22 Mar 2019
Last updated: 12 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System
ClinicalTrials.gov ID: NCT03908125
Acronym / sponsor ID: PAS / CTP-0034
Conditions: Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 273 participants (actual)
Lead sponsor: Senseonics, Inc.Industry (pharma, biotech, devices)
Study start: 19 Mar 2019 (actual)
Primary completion: 1 Feb 2024 (actual)
Study completion: 1 Feb 2024 (actual)
First posted: 9 Apr 2019 (actual)
Results: Posted 12 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The PROMISE study demonstrated safety and accuracy of the CGM system up to 180 days. This PAS study will provide safety and effectiveness data up to 27 months of repeated use.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Continuous Glucose Monitoring Device	Other	Device: Eversense® CGM SystemCommercial Continuous Glucose Monitoring Device

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject has diabetes
Subject is greater than 18 years of age

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Eversense® CGM SystemContinuous Glucose monitoring device	Device	Continuous Glucose Monitoring Device

Primary outcome

The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
Time frame: up to 27 months
The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of < 4%.
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.
Time frame: Baseline and Month 12
The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.

11 secondary outcomes

The Additional Effectiveness Endpoint of Average Hours of Use Per Day
Time frame: up to 27 months
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline
Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24
Patient Satisfaction With CGM System Use (CGM-SAT Scale)
Time frame: up to 27 months
Patient Reported Diabetes Distress Scale (DDS)
Time frame: Screening, Day 180, Day 360, and Day 720
Success Rate of Insertion Procedures: Overall and by HCP Experience
Time frame: up to 27 months
Success Rate of Removal Procedures: Overall and by HCP Experience
Time frame: up to 27 months
Rate of Insertion Procedures With Serious Adverse Events
Time frame: up to 27 months
Rate of Removal Procedures With Serious Adverse Events
Time frame: up to 27 months
HCP Feedback Questionnaire Regarding Insertion
Time frame: up to 27 Months
HCP Feedback Questionnaire Regarding Removal
Time frame: up to 27 Months
Residual Dexamethasone Level in Explanted Sensors
Time frame: up to 27 months

Results and safety

Results posted to the registry on 12 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Glucose Monitoring Device	273	173

Primary outcome: The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.

Time frame: up to 27 months. Count of units. Unit: Sensor cycle

Measure	Continuous Glucose Monitoring Device n = 273
Infection	5
Secondary procedure to remove sensor	24
Procedure-related adverse event of at least moderate severity	15

Primary outcome: The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.

Time frame: Baseline and Month 12. Mean (Standard Deviation). Unit: % time in range

Measure	Baseline Time in Range n = 273
Baseline	62.9 (18.3)
Month 12	62.4 (20.1)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuous Glucose Monitoring Device	21 of 273 (7.7%)	115 of 273 (42.1%)	0 of 273

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kathleen Davis study director

Senseonics, Inc.

17 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Eversense® CGM System in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Senseonics, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. (time frame: up to 27 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03908125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.