Eversense® Non-adjunctive Use Post Approval Study

Diabetes Clinical Trial

— NA-PAS  

Official title:

A Post Approval Study to Evaluate the Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System Used Non-adjunctively

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04836546
• Other study ID #: CTP-0039
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Senseonics, Inc.
• Contact: Kathleen Davis
• Phone: 612-419-2965
• Email: kathleen.davis[@]senseonics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 925
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Device:
• Blood glucose meter
First phase: SMBG for 6 months
• Eversense CGM System
Second phase: CGM for 6 months

Locations

Country	Name	City	State
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Texas Diabetes and Endocrinology	Austin	Texas
United States	MODEL Clinical Research	Baltimore	Maryland
United States	AM Diabetes & Endocrinology	Bartlett	Tennessee
United States	Southern Maryland Medical Group	Camp Springs	Maryland
United States	Diabetes and Endocinology Specialists, Inc.	Chesterfield	Missouri
United States	Southwest Family Medicine Associates	Dallas	Texas
United States	Metro Detroit Endocrinology	Dearborn	Michigan
United States	Denver Endocrinology, Diabetes & Thyroid Center	Englewood	Colorado
United States	The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida
United States	Physician's East Endocrinology	Greenville	North Carolina
United States	CMR of Greater New Haven	Hamden	Connecticut
United States	Clinical Research Solution Institute	Houston	Texas
United States	Javara, Inc	Houston	Texas
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Endocrine Associates of West Village	Long Island City	New York
United States	LA Universal Research Center, Inc.	Los Angeles	California
United States	Tandem Clinical Research	Marrero	Louisiana
United States	RGV Endocrine Center	McAllen	Texas
United States	MedCare Research	Miami	Florida
United States	Miami Lakes Clinical Trials INC	Miami Lakes	Florida
United States	Green Mountain Research Institute	Rutland	Vermont
United States	Superior Clinical Research	Smithfield	North Carolina
United States	Springfield Clinic	Springfield	Illinois
United States	Chase Medical Research	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Senseonics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)