Eversense® Continuous Glucose Monitor (CGM): A Post-Approval Study to Evaluate the Safety and Effectiveness of the Eversense® CGM System Used Non-Adjunctively (without another meter to compare)
Eversense® Continuous Glucose Monitor (CGM): A Post-Approval Study
Protocol Number: CTP-0039
Sponsor: Senseonics™
This clinical trial is for those who haven’t used another CGM recently* and routinely check blood sugars. It can also be a great option for those who have trouble getting test strips covered or would like to try a CGM but it is not covered by insurance.
The system consists of:
- Glucose Sensor, (approximately 3.5 mm x 18.3 mm length (Inserted under the skin in the triceps area of either arm)
- Battery-powered external Transmitter (Worn externally over sensor-placed with an adhesive patch) The transmitter vibrates to signal highs or lows.
- Mobile Medical Application (MMA) available on Android or iOS smartphone or smartwatch which will display glucose information.
Summary of Study Details:
During the study, you will have 4 visits to our office and 2 telephone calls in between visits over the course of 52 weeks.
The first 6 months, participants will simply test their blood sugars as usual with a study supplied glucometer & test strips. At the 3 month mark, we conduct a brief office visit to download your glucometer. At the 6 month mark, one (1)-6month/180-day sensor is inserted and linked to your smartphone. After 6 months, you will return to the office and the sensor is removed.
General Eligibility Criteria
Must have a smart phone that can download the Eversense App and be able to use the App
*Must NOT have used any other CGM for >1 week in the past 6 months; >4 weeks in the past 12 months and/or >12 weeks in the past 3 years.
Compensation: Participants will be compensated up to $750 for study completion.
If interested in learning more, please contact our Research Coordinator, Jamie Sigg, RD,CDCES, CRC at (303) 321-2644 x 214