Trial Outcomes & Findings for PRECISION Study: Multi-center Study of Performance of a Novel Implanted CGM System Using a Next Generation Transmitter and Algorithm (NCT NCT03251079)

Last Updated: 2024-02-12

Results Overview

The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for all paired Senseonics CGM System and reference glucose measurements through 90 days of Sensor use. MARD is defined as the average of absolute difference of paired Senseonics CGM System and reference glucose readings divided by the reference glucose reading (reference) for all reference glucose values, that is: MARD = ((SUM \| (Glucose)sensor - (Glucose)reference \| / (Glucose)reference ) / n ) x 100%, where n is the total number of CGM and reference glucose pairs after 90 days of sensor use (MARD is a percentage). Lower MARDs indicate higher (better) accuracy.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

90 days

Results posted on

2024-02-12

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitoring Device Continuous glucose monitoring system: Implanted with Senseonics Eversense® Continuous Glucose Monitoring (CGM) System (Eversense® CGM System).
Overall Study STARTED	36
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuous Glucose Monitoring Device Continuous glucose monitoring system: Implanted with Senseonics Eversense® Continuous Glucose Monitoring (CGM) System (Eversense® CGM System).
Overall Study Withdrawal by Subject	1

Baseline Characteristics

PRECISION Study: Multi-center Study of Performance of a Novel Implanted CGM System Using a Next Generation Transmitter and Algorithm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Glucose Monitoring Device n=35 Participants Senseonics continuous glucose monitoring system Continuous glucose monitoring system: Implanted continuous glucose monitoring system
Age, Continuous	51.6 years STANDARD_DEVIATION 15.7 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	32 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized More than One Race	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	4 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	31 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
Body Mass Index Class: Normal, Overweight, Obese	28.2 kg/m2 STANDARD_DEVIATION 5.4 • n=5 Participants
Dominant Hand: Right, Left Right	33 participants n=5 Participants
Dominant Hand: Right, Left Left	2 participants n=5 Participants
Diabetes Type: Type I, Type II Type I	25 Participants n=5 Participants
Diabetes Type: Type I, Type II Type II	10 Participants n=5 Participants
Years Since Diabetes Diagnosis	26.0 years STANDARD_DEVIATION 14.3 • n=5 Participants
Type of insulin therapy None	5 Participants n=5 Participants
Type of insulin therapy Multiple daily injections	11 Participants n=5 Participants
Type of insulin therapy Continuous insulin infusion pump	19 Participants n=5 Participants
History of ketoacidosis and hypoglycemia in past 6 months Ketoacidosis	0 Participants n=5 Participants
History of ketoacidosis and hypoglycemia in past 6 months Hypoglycemia	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring Device n=15170 Matched CGM and YSI pairs Continuous glucose monitoring system: Implanted with Senseonics Eversense® Continuous Glucose Monitoring (CGM) System (Eversense® CGM System).
Accuracy of CGM System Through 90 Days Post-Insertion (MARD for Paired CGM and Reference Glucose Measurements)	9.6 percent Interval 8.9 to 10.4

PRIMARY outcome

Timeframe: 90 days

Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 90 days post-insertion.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitoring Device n=35 Participants Continuous glucose monitoring system: Implanted with Senseonics Eversense® Continuous Glucose Monitoring (CGM) System (Eversense® CGM System).
Safety Endpoint	0 serious adverse events Interval 0.0 to 3.5

Adverse Events

Continuous Glucose Monitoring Device

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Continuous Glucose Monitoring Device n=35 participants at risk Continuous glucose monitoring system: Implanted with Senseonics Eversense® Continuous Glucose Monitoring (CGM) System (Eversense® CGM System).
Gastrointestinal disorders Other - Gastroenteritis	2.9% 1/35 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Endocrine disorders Hypoglycemic episode	2.9% 1/35 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Musculoskeletal and connective tissue disorders Other - Wound infection left foot, grade 4	2.9% 1/35 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)

Other adverse events

Other adverse events
Measure	Continuous Glucose Monitoring Device n=35 participants at risk Continuous glucose monitoring system: Implanted with Senseonics Eversense® Continuous Glucose Monitoring (CGM) System (Eversense® CGM System).
Respiratory, thoracic and mediastinal disorders Common Cold	11.4% 4/35 • Number of events 4 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Skin and subcutaneous tissue disorders Sensor Location Site - Pain/Discomfort	5.7% 2/35 • Number of events 2 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Respiratory, thoracic and mediastinal disorders Other - Upper Respiratory Infection	8.6% 3/35 • Number of events 3 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Nervous system disorders Headache	11.4% 4/35 • Number of events 5 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Respiratory, thoracic and mediastinal disorders Other - Pneumonia	2.9% 1/35 • Number of events 1 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Skin and subcutaneous tissue disorders Other - Pilonidal cyst	2.9% 1/35 • Number of events 1 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Skin and subcutaneous tissue disorders Other - Difficulty removing sensor	2.9% 1/35 • Number of events 2 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Skin and subcutaneous tissue disorders Adhesive Patch Location Site - Irritation including redness, excoriation or ulceration	2.9% 1/35 • Number of events 2 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Skin and subcutaneous tissue disorders Other - Darkening of skin at proximal end of sensor	2.9% 1/35 • Number of events 2 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Reproductive system and breast disorders Other - Vaginal Infection	2.9% 1/35 • Number of events 1 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
General disorders Other - Dental Caries	2.9% 1/35 • Number of events 1 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)
Musculoskeletal and connective tissue disorders Other - Arthritis	2.9% 1/35 • Number of events 1 • Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 days)

Additional Information

Katherine Tweden, PhD

Senseonics, Incorporated

Phone: 651.335.2205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60