Clinical trial NCT04836546: Eversense® Non-adjunctive Use Post Approval Study
Official title: A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Keywords: Type 1 Diabetes
Type 2 Diabetes
Lead sponsor: Senseonics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 925
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

1. Subject has diabetes
2. Subject is ≥18 years of age
3. Subject has a smartphone that is internet enabled
4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
5. Subjects is willing and able to provide written signed and dated informed consent

Exclusion Criteria:

1. Subject is critically ill or hospitalized
2. 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.
3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
5. Subject is on dialysis at the time of enrollment
6. Female subjects who are pregnant, planning on becoming pregnant or nursing

Primary outcomes:
measure: Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events
timeFrame: First 6 months (phase 1) compared to second 6 months (phase 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA Universal Research Center, Inc.
state: California
city: Englewood
country: United States
facility: Denver Endocrinology, Diabetes & Thyroid Center
state: Colorado
city: Hamden
country: United States
facility: CMR of Greater New Haven
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research
state: Connecticut
city: Fort Lauderdale
country: United States
facility: The Center for Diabetes and Endocrine Care
state: Florida
city: Miami Lakes
country: United States
facility: Miami Lakes Clinical Trials INC
state: Florida
city: Miami
country: United States
facility: MedCare Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: MODEL Clinical Research
state: Maryland
city: Camp Springs
country: United States
facility: Southern Maryland Medical Group
state: Maryland
city: Dearborn
country: United States
facility: Metro Detroit Endocrinology
state: Michigan
city: Chesterfield
country: United States
facility: Diabetes and Endocinology Specialists, Inc.
state: Missouri
city: Long Island City
country: United States
facility: Endocrine Associates of West Village
state: New York
city: Greenville
country: United States
facility: Physician's East Endocrinology
state: North Carolina
city: Smithfield
country: United States
facility: Superior Clinical Research
state: North Carolina
city: Bartlett
country: United States
facility: AM Diabetes & Endocrinology
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Houston
country: United States
facility: Clinical Research Solution Institute
state: Texas
city: Houston
country: United States
facility: Javara, Inc
state: Texas
city: McAllen
country: United States
facility: RGV Endocrine Center
state: Texas
city: Rutland
country: United States
facility: Green Mountain Research Institute
state: Vermont
Study officials:
References: