Eversense® Non-adjunctive Use Post Approval Study
NA-PAS
A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively
1 other identifier
interventional
925
1 country
23
Brief Summary
This is a non-blinded, prospective, multi-center, single arm longitudinal cohort study (patient serving as their own control), to evaluate the effectiveness of diabetes with the Eversense CGM System non-adjunctively compared to self-monitoring of blood glucose (SMBG) using a blood glucose (BG) meter in participants with either Type 1 or Type 2 diabetes. Subjects will serve as their own control, with their baseline based on using SMBG to manage their diabetes for the first 6 months followed by using Eversense CGM System non-adjunctively for the second 6 months. Total follow-up duration is 12 months. The investigation will include both clinic visits and home use of Eversense CGM System. The nonadjunctive phase will have two sensors, up to 90-day duration, inserted sequentially. All care decisions specific to diabetes will be based on blood glucose (BG) values in the first phase and the Eversense CGM system values in the second phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Apr 2021
Longer than P75 for not_applicable diabetes
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
April 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedAugust 13, 2025
August 1, 2025
5 years
March 30, 2021
August 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events
Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events with SMBG use for 6 months compared to Eversense CGM system used non-adjunctively for 6 months
First 6 months (phase 1) compared to second 6 months (phase 2)
Study Arms (1)
Self monitoring of blood glucose, then CGM System
EXPERIMENTALAll participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months
Interventions
First phase: SMBG for 6 months
Second phase: CGM for 6 months
Eligibility Criteria
You may qualify if:
- Subject has diabetes
- Subject is ≥18 years of age
- Subject has a smartphone that is internet enabled
- Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
- Subjects is willing and able to provide written signed and dated informed consent
You may not qualify if:
- Subject is critically ill or hospitalized
- Prior use of CGM defined as:
- No more than 1 week of continuous CGM use in the last 6 months, and
- At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.
- Subject has a known contraindication to dexamethasone or dexamethasone acetate
- Subjects requiring intravenous mannitol or mannitol irrigation solutions
- Subject is on dialysis at the time of enrollment
- Female subjects who are pregnant, planning on becoming pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Senseonics, Inc.lead
Study Sites (23)
LA Universal Research Center, Inc.
Los Angeles, California, 90057, United States
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, 80113, United States
CMR of Greater New Haven
Hamden, Connecticut, 06517, United States
Chase Medical Research
Waterbury, Connecticut, 06708, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312, United States
MedCare Research
Miami, Florida, 33165, United States
Miami Lakes Clinical Trials INC
Miami Lakes, Florida, 33014, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Southern Maryland Medical Group
Camp Springs, Maryland, 20746, United States
Metro Detroit Endocrinology
Dearborn, Michigan, 48126, United States
Diabetes and Endocinology Specialists, Inc.
Chesterfield, Missouri, 63017, United States
Endocrine Associates of West Village
Long Island City, New York, 11101, United States
Physician's East Endocrinology
Greenville, North Carolina, 27834, United States
Superior Clinical Research
Smithfield, North Carolina, 27577, United States
AM Diabetes & Endocrinology
Bartlett, Tennessee, 38133, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78749, United States
Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
Clinical Research Solution Institute
Houston, Texas, 77095, United States
RGV Endocrine Center
McAllen, Texas, 78503, United States
Green Mountain Research Institute
Rutland, Vermont, 05701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2021
First Posted
April 8, 2021
Study Start
April 13, 2021
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
August 13, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share