Trial Outcomes & Findings for PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days (NCT NCT03808376)

Last Updated: 2024-08-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

208 participants

Primary outcome timeframe

180 days

Results posted on

2024-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitoring Device The Eversense® 180 CGM System Continuous Glucose Monitoring System: The Eversense® 180 CGM System
Overall Study STARTED	181
Overall Study Received SBA Sensor	43
Overall Study COMPLETED	171
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Continuous Glucose Monitoring Device The Eversense® 180 CGM System Continuous Glucose Monitoring System: The Eversense® 180 CGM System
Overall Study Withdrawal by Subject	10

Baseline Characteristics

PROMISE Study: An Evaluation of an Implantable Continuous Glucose Sensor up to 180 Days

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Eversense® 180 CGM System All Subject n=181 Participants All subjects inserted with a study sensor(s).
Age, Continuous	48.6 years STANDARD_DEVIATION 14.9 • n=99 Participants
Sex: Female, Male Female	96 Participants n=99 Participants
Sex: Female, Male Male	85 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	23 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants
Race (NIH/OMB) Asian	4 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	10 Participants n=99 Participants
Race (NIH/OMB) White	163 Participants n=99 Participants
Race (NIH/OMB) More than one race	2 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	181 Participants n=99 Participants
Body Mass Index Class Normal (<25 kg/m2)	28 Participants n=99 Participants
Body Mass Index Class Overweight (>25 and <30)	53 Participants n=99 Participants
Body Mass Index Class Obese (>30)	100 Participants n=99 Participants
Years since diabetes diagnosis	22.0 years STANDARD_DEVIATION 13.3 • n=99 Participants
Diabetes type Type 1	126 Participants n=99 Participants
Diabetes type Type 2	55 Participants n=99 Participants
Type of insulin therapy None (oral diabetes medications only)	16 Participants n=99 Participants
Type of insulin therapy Multiple daily injections	65 Participants n=99 Participants
Type of insulin therapy Continuous insulin infusion pump	92 Participants n=99 Participants
Type of insulin therapy Other (Basal only or 1 injection per day)	8 Participants n=99 Participants
History of ketoacidosis and hypoglycemia in past 6 months Ketoacidosis	0 Participants n=99 Participants
History of ketoacidosis and hypoglycemia in past 6 months Hypoglycemia	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: 180 days

Outcome measures

Outcome measures
Measure	The Eversense® 180 CGM System All Subject n=49613 Matched CGM and YSI pairs All subjects inserted with a study sensor	The Eversense® 180 CGM System SBA Subgroup n=12034 Matched CGM and YSI pairs Subjects inserted with Eversense® 180 CGM system with slightly modified indicator hydrogel containing sacrificial boronic acid (referred to as SBA Sensor).
Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements	9.1 percent Interval 8.7 to 9.5	8.5 percent Interval 8.0 to 9.0

PRIMARY outcome

Timeframe: 180 days

Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure.

Outcome measures

Outcome measures
Measure	The Eversense® 180 CGM System All Subject n=181 Participants All subjects inserted with a study sensor	The Eversense® 180 CGM System SBA Subgroup n=43 Participants Subjects inserted with Eversense® 180 CGM system with slightly modified indicator hydrogel containing sacrificial boronic acid (referred to as SBA Sensor).
Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events	0 serious adverse events Interval 0.0 to 2.0	0 serious adverse events Interval 0.0 to 8.2

Adverse Events

The Eversense® 180 CGM System All Subject Evaluation

Serious events: 7 serious events

Other events: 118 other events

Deaths: 0 deaths

The Eversense® 180 CGM System SBA Subgroup

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	The Eversense® 180 CGM System All Subject Evaluation n=181 participants at risk All subjects inserted with a study sensor.	The Eversense® 180 CGM System SBA Subgroup n=43 participants at risk Subjects inserted with Eversense® 180 CGM system with slightly modified indicator hydrogel containing sacrificial boronic acid (referred to as SBA Sensor).
Reproductive system and breast disorders Invasive lobular carcinoma	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Reproductive system and breast disorders Post-surgical staphylococcus infection in left breast	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Humerus Fracture	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Endocrine disorders hypoglycemic event	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Nervous system disorders Chronic behavioral issues	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Endocrine disorders Diabetic ketoacidosis event requiring hospitalization	0.55% 1/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders hiatal hernia	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Endocrine disorders hyperglycemia	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)

Other adverse events

Additional Information

Vice President, Clinical Sciences

Senseonics

Phone: 301-515-7260

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	The Eversense® 180 CGM System All Subject Evaluation n=181 participants at risk All subjects inserted with a study sensor.	The Eversense® 180 CGM System SBA Subgroup n=43 participants at risk Subjects inserted with Eversense® 180 CGM system with slightly modified indicator hydrogel containing sacrificial boronic acid (referred to as SBA Sensor).
Skin and subcutaneous tissue disorders Skin irritation, adhesive patch location (including erythema, pruritus, rash, contact dermatitis)	5.0% 9/181 • Number of events 13 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	4.7% 2/43 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Skin irritation, not device related (including abrasion, laceration, redness, tear, rash, contact de	3.9% 7/181 • Number of events 8 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Hypopigmentation	1.7% 3/181 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Infection (not related)	2.2% 4/181 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Skin atrophy	2.2% 4/181 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Skin cancer (left forearm, scalp, ear, nose)	1.7% 3/181 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Infection (insertion/removal site, under adhesive patch)	1.7% 3/181 • Number of events 3 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Contact dermatitis/Rash (drape adhesive, heat related)	1.7% 3/181 • Number of events 3 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Burn	1.1% 2/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Erythema, insertion site	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Skin and subcutaneous tissue disorders Seroma, removal site	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	15.5% 28/181 • Number of events 31 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	16.3% 7/43 • Number of events 8 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Respiratory, thoracic and mediastinal disorders Bronchitis	3.3% 6/181 • Number of events 7 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	7.0% 3/43 • Number of events 3 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Respiratory, thoracic and mediastinal disorders Influenzas	3.3% 6/181 • Number of events 6 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	11.6% 5/43 • Number of events 5 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Respiratory, thoracic and mediastinal disorders Chest congestion	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Respiratory, thoracic and mediastinal disorders Cough	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Respiratory, thoracic and mediastinal disorders Pneumonia	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Cardiac disorders Chest pain with tachycardia, dizziness	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Vascular disorders Lower extremity edema, bilateral	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Cardiac disorders Sinus tachycardia	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Gastrointestinal disorders Nausea/Vomiting	3.9% 7/181 • Number of events 7 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	7.0% 3/43 • Number of events 3 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Gastrointestinal disorders Abdominal pain/discomfort	1.1% 2/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Gastrointestinal disorders Diarrhea	1.1% 2/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Gastrointestinal disorders Gastroenteritis	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Nervous system disorders Headache (1 w/ dizziness)	11.0% 20/181 • Number of events 31 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	9.3% 4/43 • Number of events 5 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Nervous system disorders Pain	5.0% 9/181 • Number of events 10 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	7.0% 3/43 • Number of events 3 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Nervous system disorders Migraine with nausea	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Nervous system disorders Arm Numbness	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Nervous system disorders Tremor	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Pain (back, forehead, hand, neck, etc. )	3.9% 7/181 • Number of events 8 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Muscle/Connective tissue injury	3.3% 6/181 • Number of events 6 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	4.7% 2/43 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Bone Fracture	2.2% 4/181 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	4.7% 2/43 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Sprain	2.2% 4/181 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Arthritis/Osteoarthritis	1.1% 2/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 12 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Carpal tunnel	1.1% 2/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	4.7% 2/43 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Trigger finger	1.1% 2/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Musculoskeletal and connective tissue disorders Puncture wound, right foot	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Renal and urinary disorders UTI	2.8% 5/181 • Number of events 5 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	4.7% 2/43 • Number of events 3 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders HSV flare	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Infections and infestations Vaginal candidiasis	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Endocrine disorders Hyperglycemia/DKA	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Endocrine disorders Hypoglycemic episode	1.1% 2/181 • Number of events 3 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Endocrine disorders Hyperthyroidism	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Blood and lymphatic system disorders Bruising	7.2% 13/181 • Number of events 22 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	14.0% 6/43 • Number of events 9 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Blood and lymphatic system disorders Bleeding	1.7% 3/181 • Number of events 3 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Blood and lymphatic system disorders Iron Deficiency	1.1% 2/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	4.7% 2/43 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Blood and lymphatic system disorders Ecchymosis, IV site	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Fever	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Antibiotic allergy	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Food/Drink allergy	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Seasonal allergy	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Dental work/issues	4.4% 8/181 • Number of events 8 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Eye disorders Cataract	2.2% 4/181 • Number of events 6 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Ear and labyrinth disorders Otitis media	2.2% 4/181 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Infections and infestations Sinus infection	2.2% 4/181 • Number of events 4 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Infections and infestations Pharyngitis	0.55% 1/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Eye disorders Retinopathy	1.1% 2/181 • Number of events 2 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Infections and infestations Cold sores	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
Eye disorders Corneal ulcer	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Lipoplasty, lower extremities	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Bariatric surgery	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Malaise	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Thumb tip cut off, right	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	0.00% 0/43 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
General disorders Steristrips did not hold, replaced	0.55% 1/181 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)	2.3% 1/43 • Number of events 1 • Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)