18 and older, any sex, with Diabetes Mellitus or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.Primary· up to 27 months
The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of \< 4%.
Infection
Group
Value
95% CI
Continuous Glucose Monitoring Device
5
Secondary procedure to remove sensor
Group
Value
95% CI
Continuous Glucose Monitoring Device
24
Procedure-related adverse event of at least moderate severity
Group
Value
95% CI
Continuous Glucose Monitoring Device
15
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting.Primary· Baseline and Month 12
The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion.
Baseline
Group
Value
95% CI
Baseline Time in Range
62.9
± 18.3
Month 12
Group
Value
95% CI
Baseline Time in Range
62.4
± 20.1
The Additional Effectiveness Endpoint of Average Hours of Use Per DaySecondary· up to 27 months
Group
Value
95% CI
Continuous Glucose Monitoring Device
19
± 7
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From BaselineSecondary· Baseline, Month 6, Month 12, Month 18, and Month 24
Baseline
Group
Value
95% CI
Continuous Glucose Monitoring Device
0
± 0
6-month
Group
Value
95% CI
Continuous Glucose Monitoring Device
-0.16
± 1.04
12-month
Group
Value
95% CI
Continuous Glucose Monitoring Device
-0.14
± 0.96
18-month
Group
Value
95% CI
Continuous Glucose Monitoring Device
-0.10
± 0.96
24-month
Group
Value
95% CI
Continuous Glucose Monitoring Device
0.06
± 1.31
Patient Satisfaction With CGM System Use (CGM-SAT Scale)Secondary· up to 27 months
CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM.
Day 180
Group
Value
95% CI
Continuous Glucose Monitoring Device
4.0
± 0.5
Day 360
Group
Value
95% CI
Continuous Glucose Monitoring Device
4.1
± 0.5
Day 720
Group
Value
95% CI
Continuous Glucose Monitoring Device
4.1
± 0.5
Patient Reported Diabetes Distress Scale (DDS)Secondary· Screening, Day 180, Day 360, and Day 720
The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes.
Screening
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.9
± 0.8
Day 180
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.7
± 0.7
Day 360
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.7
± 0.7
Day 720
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.7
± 0.7
Success Rate of Insertion Procedures: Overall and by HCP ExperienceSecondary· up to 27 months
Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions.
First 3 procedures
Group
Value
95% CI
Continuous Glucose Monitoring Device
100
>3 procedures done
Group
Value
95% CI
Continuous Glucose Monitoring Device
99.8
Overall
Group
Value
95% CI
Continuous Glucose Monitoring Device
99.8
Success Rate of Removal Procedures: Overall and by HCP ExperienceSecondary· up to 27 months
Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals.
First 3 procedures
Group
Value
95% CI
Continuous Glucose Monitoring Device
96.1
>3 procedures done
Group
Value
95% CI
Continuous Glucose Monitoring Device
98.7
Overall
Group
Value
95% CI
Continuous Glucose Monitoring Device
98.4
Rate of Insertion Procedures With Serious Adverse EventsSecondary· up to 27 months
Group
Value
95% CI
Continuous Glucose Monitoring Device
1
Rate of Removal Procedures With Serious Adverse EventsSecondary· up to 27 months
Group
Value
95% CI
Continuous Glucose Monitoring Device
0
HCP Feedback Questionnaire Regarding InsertionSecondary· up to 27 Months
The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.
The insertion procedure was easy
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.1
± 0.4
The labeling for use of the blunt dissector and the insertion tool are easy to understand
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.1
± 0.4
The blunt dissector and insertion tool are easy to use
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.1
± 0.3
The training was reflective of what I encountered during the insertion procedure
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.2
± 0.5
HCP Feedback Questionnaire Regarding RemovalSecondary· up to 27 Months
The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree.
The removal procedure was easy
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.5
± 0.8
The instructions and labeling for the removal were easy to understand
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.2
± 0.5
The clamp was easy to use to remove the sensor
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.5
± 0.7
The training was reflective of what I encountered during the removal procedure
Group
Value
95% CI
Continuous Glucose Monitoring Device
1.4
± 0.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were reported from enrollment until study participation completion (approximately 27 months). Adverse events were followed until resolution, AE had stabilized, or the study had been completed. All AEs were adjudicated by CEC members..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Continuous Glucose Monitoring Device
Serious: 21/273 (8%)
Deaths: 0/273
Serious adverse events (19 terms)
Reaction
System
Continuous Glucose Monitor…
Hypoglycemic episode
Endocrine disorders
—
Diabetic Ketoacidosis
Endocrine disorders
—
Congestive heart failure exacerbation
Cardiac disorders
—
Depression requiring hospitalization
Psychiatric disorders
—
Appendicitis
Gastrointestinal disorders
—
Fracture of tibia and fibula
Musculoskeletal and connective tissue disorders
—
Hypoglycemia w/acute metabolic encephalopathy
Endocrine disorders
—
Acute stroke with ataxia
Nervous system disorders
—
Cellulitis, bilateral lower extremity
Skin and subcutaneous tissue disorders
—
Foot infection, left
Musculoskeletal and connective tissue disorders
—
Subdural hemorrhage
Nervous system disorders
—
Subarachnoid hemorrhage
Nervous system disorders
—
COVID-19 infection
Respiratory, thoracic and mediastinal disorders
—
Acute renal failure
Renal and urinary disorders
—
Acute on chronic systolic heart failure
Cardiac disorders
—
Hyperglycemic hyperosmolar nonketotic
Endocrine disorders
—
Sepsis
Infections and infestations
—
Infection, Sensor insertion site
Infections and infestations
—
Myxedema crisis
Endocrine disorders
—
Other adverse events (206 terms — click to expand)
A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Senseonics, Inc.
Last refreshed: 12 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03908125.