Continuous Glucose Monitoring for Diabetes
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Senseonics, Inc.
Must not be taking: Immunosuppressants, Chemotherapy, Anticoagulants, others
Disqualifiers: Severe hypoglycemia, Ketoacidosis, Gastroparesis, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing devices that monitor blood sugar levels in adults with diabetes and children with Type 1 Diabetes. The goal is to see how accurate and safe these devices are for managing diabetes. These devices allow people with diabetes to keep track of their blood glucose levels in near real-time.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant therapy, chemotherapy, anticoagulant/antithrombotic therapy (except aspirin), or antibiotics for chronic infection, you may not be eligible to participate.
What data supports the effectiveness of the Eversense CGM System for diabetes management?
The Eversense CGM System has shown promising results in managing diabetes by providing accurate and consistent glucose monitoring over multiple cycles, with a high percentage of time spent in the target glucose range and no serious adverse events reported. This system is valued for its long-term implantable sensor, which offers real-time data to help people with diabetes manage their condition effectively.
12345Is the Eversense Continuous Glucose Monitoring System safe for humans?
The Eversense Continuous Glucose Monitoring System has been shown to be safe in clinical trials, with no serious adverse events related to the device or its insertion/removal procedures reported. Real-world data also support its safety, making it a valuable tool for managing diabetes.
12367What makes the Eversense CGM System unique compared to other diabetes treatments?
The Eversense CGM System is unique because it features a fully implantable sensor that can last up to 180 days, providing continuous glucose monitoring without the need for frequent sensor replacements, unlike other CGM systems that require more frequent changes.
12457Eligibility Criteria
Adults and adolescents with diabetes (Type 1 or Type 2) can join this trial. Adults must have had diabetes for at least a year, while teens aged 14-17 need a confirmed diagnosis of Type 1 Diabetes for the same duration. Participants must consent to follow study rules. Those with certain health issues, drug abuse history, severe hypoglycemia, specific infections like hepatitis or HIV, allergies to anesthetics or glucocorticoids, recent heart problems, uncontrolled hypertension, or who are pregnant cannot join.Inclusion Criteria
I am a teenager with type 1 diabetes diagnosed over a year ago.
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.
I have been diagnosed with diabetes for at least a year.
+4 more
Exclusion Criteria
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
You have a condition that needs or may need a magnetic resonance imaging (MRI) scan.
I have a seizure disorder but have clearance from a neurologist to join the study.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants use the Eversense 524 CGM System and ROME CGM System to evaluate accuracy and safety
52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The Eversense CGM System is being tested for its accuracy and safety in monitoring blood sugar levels compared to standard glucose tests. This includes new features in the system designed to improve user experience. The study involves adults and some teenagers with diabetes and will compare readings from the device with traditional reference measurements.
1Treatment groups
Experimental Treatment
Group I: Continuous Glucose Monitoring DeviceExperimental Treatment1 Intervention
Eversense 524 CGM System and ROME CGM System.
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:
AMCR Institute Inc.Escondido, CA
Rocky Mountain Diabetes Center, LLC. (RMDC)Idaho Falls, ID
Clinical Trials of Texas, LLC. (CTT)San Antonio, TX
Rainier Clinical Research CenterRenton, WA
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Who Is Running the Clinical Trial?
Senseonics, Inc.Lead Sponsor
References
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.
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.
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.
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).
Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. [2023]Adverse events for continuous glucose monitors (CGMs) represent a significant issue for people with diabetes with 281 963 CGM adverse events occurring in 2022. The process to obtain adverse events and the US Food and Drug Administration (FDA) database that contains them are reviewed.
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.