Eversense CGM for Diabetes
(NA-PAS Trial)
Recruiting in Palo Alto (17 mi)
+23 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Senseonics, Inc.
Must not be taking: Dexamethasone
Disqualifiers: Critically ill, Dialysis, Pregnant, others
Stay on Your Current Meds
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is evaluating whether a continuous glucose monitor may help people with diabetes better manage their blood sugar.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on comparing two methods of monitoring blood sugar, so you may not need to change your medications, but it's best to confirm with the trial organizers.
What data supports the effectiveness of the Eversense CGM System treatment for diabetes?
Research shows that the Eversense CGM System helps people with diabetes manage their blood sugar levels effectively. In studies, it provided accurate glucose readings and improved blood sugar control over time, with many users reporting positive experiences and requesting continued use.
12345Is the Eversense CGM System safe for use in humans?
The Eversense CGM System has been shown to be safe in humans, with studies reporting no serious adverse events related to the device or its insertion/removal procedures. It has been used successfully in both clinical trials and real-world settings for managing diabetes.
23467Eligibility Criteria
Adults with Type 1 or Type 2 diabetes who have never used a continuous glucose monitor (CGM) for more than one week in the last six months. Participants must own an internet-enabled smartphone and be able to follow study instructions. Critically ill patients, those on dialysis, pregnant or nursing women, and individuals with certain medical conditions are excluded.Inclusion Criteria
I am 18 years old or older.
I have diabetes.
Subjects is willing and able to provide written signed and dated informed consent
+11 more
Exclusion Criteria
I am critically ill or currently in the hospital.
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.
I am currently receiving dialysis.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline
Participants manage their diabetes using self-monitoring of blood glucose (SMBG) for 6 months
6 months
Regular clinic visits and home monitoring
Non-adjunctive CGM Use
Participants use the Eversense CGM System non-adjunctively for 6 months
6 months
Regular clinic visits and home monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing the Eversense CGM System's effectiveness compared to traditional blood glucose meter monitoring over a year. For the first six months, participants will use their usual blood glucose meters; for the next six months, they'll switch to using Eversense CGM non-adjunctively.
1Treatment groups
Experimental Treatment
Group I: Self monitoring of blood glucose, then CGM SystemExperimental Treatment2 Interventions
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
Eversense CGM System is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Eversense Continuous Glucose Monitoring System for:
- Continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days
🇪🇺 Approved in European Union as Eversense XL for:
- Continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 180 days
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
RGV Endocrine CenterMcAllen, TX
Endocrine Associates of West VillageLong Island City, NY
Chase Medical ResearchWaterbury, CT
Miami Lakes Clinical Trials INCMiami Lakes, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Senseonics, Inc.Lead Sponsor
References
First assessment of the performance of an implantable continuous glucose monitoring system through 180 days in a primarily adolescent population with type 1 diabetes. [2022]To investigate the performance of the Eversense XL implantable continuous glucose monitoring (CGM) system through 180 days in a primarily adolescent population with type 1 diabetes (T1D).
Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor. [2020]Background: The Eversense® Continuous Glucose Monitoring (CGM) System, with the first 90-day implantable sensor, received FDA (Food and Drug Administration) approval in June 2018. No real-world experience has been published. Methods: Deidentified sensor glucose (SG) data from August 1, 2018 to May 11, 2019 in the Eversense Data Management System (DMS) were analyzed for the first 205 patients who reached a 90-day wear period on the Eversense CGM system. The mean SG, standard deviation (SD), median interquartile range, coefficient of variation (CV), glucose measurement index (GMI), and percent and time in minutes across glucose ranges were computed for the 24-h time period, the nighttime (00:00-06:00), and by 30-day wear periods. Sensor accuracy, sensor reinsertion rate, transmitter wear time, and safety data were assessed. Results: Of the 205 patients, 129 identified as type 1, 18 as type 2, and 58 were unreported. Fifty were CGM naive, 112 had prior CGM experience, and 43 were unreported. The mean SG was 161.8 mg/dL, SD was 57.4 mg/dL, CV was 0.35, and GMI was 7.18%. Percent SG at <54 mg/dL was 1.2% (18 min), <70 mg/dL was 4.1% (59.7 min), time in range (≥70-180 mg/dL) was 62.3% (897.7 min), >180-250 mg/dL was 21.9% (315.8 min), and >250 mg/dL was 11.6% (166.7 min). Nighttime values were similar. The glucometric values were similar over 30-day time periods of the sensor wear. The mean absolute relative difference (SD) using 27,708 calibration paired points against home blood glucose meters was 11.2% (11.3%). The sensor reinsertion rate was 78.5%. The median transmitter wear time was 83.6%. There were no related serious adverse events. Conclusion: The Eversense real-world data showed promising glycemic results, sensor accuracy, and safety. These data suggest that the Eversense CGM system is a valuable tool for diabetes management.
Review of the Long-Term Implantable Senseonics Continuous Glucose Monitoring System and Other Continuous Glucose Monitoring Systems. [2021]The article published by Kevin Cowart in this issue of the Journal of Diabetes Science and Technology (JDST) is a detailed overview of the clinical trial data and analysis used to demonstrate the safety and effectiveness of the Eversense continuous glucose monitoring (CGM) System for regulatory approval and clinical acceptance. The article describes the published study results for safety, accuracy, reliability, ease of insertion/removal, adverse events, and ease of diabetes patient-use for controlling their glucose levels short and long term. The author nicely compares Eversense CGM System safety and performance with the short-term subcutaneous tissue CGM systems being commercialized by Dexcom, Medtronic Diabetes, and Abbott Diabetes. This comparison may help the clinician define which type of patient with diabetes might benefit the most from the long-term implantable CGM system. The majority of studied patients describe a positive experience managing their diabetes with the Eversense CGM System and request implantation of a new sensor 90 or 180 days later.
Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy. [2022]Continuous glucose monitoring (CGM) systems offer real-time data to facilitate diabetes management. The novel Eversense CGM has been approved in Europe and the US. The unique characteristics are the fully implantable sensor and the sensor life up to 180 days.
Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes. [2022]This real-world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180-day Eversense CGM System (Eversense) in patients with type 1 diabetes.
A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study. [2020]Background: A prior study (PRECISE II) demonstrated that an implantable continuous glucose monitoring (CGM) system (Eversense® CGM System) provided accurate glucose readings through the 90-day sensor life with a favorable safety profile in participants with type 1 or type 2 diabetes (T1D, T2D). This study was performed to further characterize the accuracy of the system. Methods: PRECISION was a prospective multicenter study that evaluated the accuracy and safety of Eversense among adults with T1D or T2D through 90 days (NCT02647905). Accuracy measures included percentage system agreement and mean absolute relative difference (MARD) between Eversense and Yellow Springs Instrument reference measurements from 40 to 400 mg/dL. The primary safety endpoint was incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days. An updated glucose calculation algorithm was also applied to the sensor data from the PRECISE II study to evaluate consistency of accuracy results. Results: Thirty-five participants received the CGM system. Eighty-five percent of CGM values were within 15/15% of reference and the MARD value against reference was 9.6% (95% confidence interval [CI]: 8.9-10.4). All sensors were functional through day 90. No device- or procedure-related SAEs occurred. Application of the updated algorithm to PRECISE II sensor data resulted in 87% of readings within 15/15% of reference and an MARD value against reference of 8.5% (95% CI: 8.0%-9.1%). Conclusions: PRECISION corroborated prior accuracy and safety findings of the Eversense CGM System through the 90-day sensor life. The updated algorithm improved accuracy of measurements in PRECISE II.
Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor over Multiple Sensor Insertion and Removal Cycles. [2021]The Eversense® Continuous Glucose Monitoring (CGM) System, with the first long-term, implantable glucose sensor, has been commercially available in Europe and South Africa since 2016 for adults with diabetes. The performance of the sensor over multiple, sequential 90- or 180-day cycles from either real-world experience or clinical studies has not been previously published. The Eversense Data Management System (DMS) was used to evaluate the accuracy of General Data Protection Regulation (GDPR)-compliant sensor glucose (SG) values against self-monitoring of blood glucose (SMBG) from June 2016 through August 2019 among patients with at least four sensor cycles from European and South African health care practices. Mean SG and associated measures of variability, glucose management indicator (GMI), and percent and time in various hypoglycemic, euglycemic, and hyperglycemic ranges were calculated for the 24-h time period over each cycle. In addition, transmitter wear time was evaluated across each sensor wear cycle. Among the 945 users included in the analysis, the mean absolute relative difference (standard deviation [SD]) using 152,206, 174,645, 206,024, and 172,587 calibration matched pairs against SMBG was 11.9% (3.6%), 11.5% (4.0%), 11.8% (4.7%), and 11.5% (4.1%) during the first four sensor cycles, respectively. Mean values of the CGM metrics over the first sensor cycle were 156.5 mg/dL for SG, 54.7 mg/dL for SD, 0.35 for coefficient of variation, and 7.04% for GMI. Percent SG at different glycemic ranges was as follows: <54 mg/dL was 1.1% (16 min), <70 mg/dL was 4.6% (66 min), ≥70-180 mg/dL (time in range) was 64.5% (929 min), >180-250 mg/dL was 22.8% (328 min), and >250 mg/dL was 8.1% (117 min). The median transmitter wear time over the first cycle was 83.2%. CGM metrics and wear time were similar over the subsequent three cycles. This real-world evaluation of adult patients with diabetes using the Eversense CGM System in the home setting demonstrated that the implantable sensor provides consistent stable accuracy and CGM metrics over multiple, sequential sensor cycles with no indication of degradation of sensor performance.