Diabetes MellitusPROMISENCT03808376
PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days
A study testing Continuous Glucose Monitoring System in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Senseonics, Inc. at 8 sites in United States.
Trial summary
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use. 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?
- Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 8 sitesUnited States
- Study dates
- 27 Dec 2018to 8 May 2020
- 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
- Adult subjects, age ≥18 years
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form and is willing to comply with protocol requirements
Who cannot join
- 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 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.
- 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.
Show all 17Show fewer
- Hematocrit <30% or >60%
- 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); glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotic for chronic infection (e.g. osteomyelitis, endocarditis)
- 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
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Atlanta Diabetes Care
Atlanta, Georgia, 30318
Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
John Muir Physician Network Clinical Research Center
Concord, California, 94520
AMCR Institute Inc.
Escondido, California, 92025
Rocky mountain Diabetes Center C/O Research Department
Idaho Falls, Idaho, 83404
Rainier Clinical Research Center
Renton, Washington, 98057
Clinical Trials of Texas
San Antonio, Texas, 78229
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Official title: PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use.
The investigation will also evaluate safety of the Eversense® 180 CGM System usage.
- 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
Also called Eversense CGM system
The Eversense® 180 CGM System
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring Device | Experimental | The Eversense® 180 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 Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements
The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM | (Glucose)sensor - (Glucose)reference | / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy.
Measured: 180 days
Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start27 Dec 2018
- Primary completion8 May 2020
- Study completion8 May 2020
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
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senseonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Satish Garg, MD, Principal investigator, Barbara Davis Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808376
- Sponsor's protocol ID
- CTP-0036
- Acronym
- PROMISE
- Status last verified
- Jul 2024
- First submitted
- 15 Jan 2019
- Last updated
- 20 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 Days
- ClinicalTrials.gov ID
- NCT03808376
- Acronym / sponsor ID
- PROMISE / CTP-0036
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Senseonics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Posted 20 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use.
The investigation will also evaluate safety of the Eversense® 180 CGM System usage.
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 SystemThe Eversense® 180 CGM System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects, age ≥18 years
- Clinically confirmed diagnosis of diabetes mellitus for ≥1 year
- Subject has signed an informed consent form and is willing to comply with protocol requirements
Key exclusion criteria (17 listed)
- 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 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.
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 SystemAlso: Eversense CGM systemThe Eversense® 180 CGM System | Device | Continuous Glucose Monitoring Device |
Primary outcome
Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements
Time frame: 180 days
The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM | (Glucose)sensor - (Glucose)reference | / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy.
Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events
Time frame: 180 days
Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
RecruitingPhase 2
CAlcium and VAsopressin Following Injury Early Resuscitation (CAVALIER) Trial
Trauma, Hemorrhage
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
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.
Satish Garg, MD principal investigator
Barbara Davis Center
8 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 8 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 3 inclusion and 17 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 20 Aug 2024). 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?
Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements (time frame: 180 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?
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 20 Aug 2024.