Diabetes MellitusNCT05131139
Enhance Study: Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
A study testing Continuous Glucose Monitoring System in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Senseonics, Inc. at 4 sites in United States.
Trial summary
A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) and ROME CGM System with next generation feature… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Oct 2021to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects meeting all of the following inclusion criteria will be included in this study:
- Subjects ≥14 years of age
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year for adults 18 years and older
- Clinically confirmed diagnosis of type I diabetes mellitus for ≥1 year for adolescents 14 -17 years old
- Subject has signed an informed consent or assent form and parent/guardian has signed an informed consent, as applicable, and subject is willing to comply with protocol requirements.
Who cannot join
- Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure.
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months.
- Subjects with gastroparesis.
- Female subjects of childbearing capacity (defined as of child bearing age and as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
- A condition preventing or complicating the placement, operation, or removal of the sensor or wearing of transmitter, including upper extremity deformities or skin condition.
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- Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign PACs and PVCs allowed). Subjects with asymptomatic coronary artery disease (e.g., CABG, stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
- Hematocrit <38% or >60% at screening
- History of hepatitis B, hepatitis C, or HIV
- Current treatment for a seizure disorder unless written clearance by neurologist to participate in study.
- History of adrenal insufficiency
- Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); topical glucocorticoids over sensor site only; antibiotic for chronic infection (e.g., osteomyelitis, endocarditis)
- For subjects inserted with the ROME CGM System: A condition requiring or likely to require magnetic resonance imaging (MRI)
- Known topical or local anesthetic allergy
- Known allergy to glucocorticoids
- Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion
- Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
- The presence of any other active implanted device (as defined further in protocol)
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
AMCR Institute Inc.
Escondido, California, 92025
Timothy Bailey, MD, 877-567-2627, tbailey@amcrinstitute.com
- Recruiting
Rocky Mountain Diabetes Center, LLC. (RMDC)
Idaho Falls, Idaho, 83404
Mark Sulik, 208-523-1122, mark@idahomed.com
Joseph Rogers, 208-523-1122, joseph.rogers@idahomed.com
- Recruiting
Rainier Clinical Research Center
Renton, Washington, 98057
Ronald Brazg, MD, 425-251-1720 ext. 313, rbrazg@rainier-research.com
Tina Mitchell, 425-251-1720, tmitchell@rainer-research.com
- Recruiting
Clinical Trials of Texas, LLC. (CTT)
San Antonio, Texas, 78229
Shelbie Martin, 210-949-0122 ext. 161
Sierra Wilson, 210-949-0122 ext. 208, swilson@cttexas.com
About this study
Official title: Enhance Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) and ROME CGM System with next generation feature enhancements compared to reference glucose measurements in adults 18 years of age and older with diabetes. The investigation will also evaluate safety of the Eversense 524 CGM System and ROME CGM System usage. Additionally, the safety and accuracy of the Eversense 524 CGM System will be evaluated in the pediatric population ages 14-17 with Type 1 Diabetes Mellitus.
- Being tested
- Continuous Glucose Monitoring 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.
Continuous Glucose Monitoring SystemDevice
Eversense 524 CGM System and ROME CGM System.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring Device | Experimental | Eversense 524 CGM System and ROME CGM System. Receives: Device: Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System.
The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements through 365 days post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively.
Measured: 365 days
Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System.
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start20 Oct 2021
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senseonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131139
- Sponsor's protocol ID
- CTP-0041
- Status last verified
- Apr 2023
- First submitted
- 10 Nov 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bailey TS, Liljenquist DR, Denham DS, Brazg RL, Ioacara S, Masciotti J, Ghosh-Dastidar S, Tweden KS, Kaufman FR. Evaluation of Accuracy and Safety of the 365-Day Implantable Eversense Continuous Glucose Monitoring System: The ENHANCE Study. Diabetes Technol Ther. 2025 May;27(5):407-411. doi: 10.1089/dia.2024.0592. Epub 2025 Jan 27.
PubMed 39869118
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhance Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System With Enhanced Features
- ClinicalTrials.gov ID
- NCT05131139
- Acronym / sponsor ID
- CTP-0041
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Senseonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Prospective, Multicenter Evaluation of Accuracy and Safety of the Eversense CGM System with Enhanced Features. The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 CGM System) and ROME CGM System with next generation feature enhancements compared to reference glucose measurements in adults 18 years of age and older with diabetes. The investigation will also evaluate safety of the Eversense 524 CGM System and ROME CGM System usage. Additionally, the safety and accuracy of the Eversense 524 CGM System will be evaluated in the pediatric population ages 14-17 with Type 1 Diabetes Mellitus.
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 | Experimental | Device: Continuous Glucose Monitoring SystemEversense 524 CGM System and ROME CGM System. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects ≥14 years of age
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year for adults 18 years and older
- Clinically confirmed diagnosis of type I diabetes mellitus for ≥1 year for adolescents 14 -17 years old
- Subject has signed an informed consent or assent form and parent/guardian has signed an informed consent, as applicable, and subject is willing to comply with protocol requirements.
Key exclusion criteria (18 listed)
- Subjects meeting any of the following exclusion criteria at the time of screening will be excluded from this study:
- History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure.
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months.
- Subjects with gastroparesis.
- Female subjects of childbearing capacity (defined as of child bearing age and as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study.
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 |
|---|---|---|
| Continuous Glucose Monitoring SystemEversense 524 CGM System and ROME CGM System. | Device | Continuous Glucose Monitoring Device |
Primary outcome
Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System.
Time frame: 365 days
The effectiveness measure will be mean absolute relative difference (MARD) for paired sensor and reference measurements through 365 days post-insertion for reference glucose values from 40-400 mg/dL. Effectiveness measures will be evaluated descriptively.
Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System.
Time frame: 365 days
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Derived from this study: PubMed 39869118Bailey TS, Liljenquist DR, Denham DS, Brazg RL, Ioacara S, Masciotti J, Ghosh-Dastidar S, Tweden KS, Kaufman FR. Evaluation of Accuracy and Safety of the 365-Day Implantable Eversense Continuous Glucose Monitoring System: The ENHANCE Study. Diabetes Technol Ther. 2025 May;27(5):407-411. doi: 10.1089/dia.2024.0592. Epub 2025 Jan 27.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring System in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Senseonics, Inc. at 4 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 5 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maggie Lewis (667-218-3309, maggie.lewis@senseonics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System. (time frame: 365 days). 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 NCT05131139, which also lists 1 linked publication.
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 26 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.