NA-PAS: Eversense® Non-adjunctive Use Post Approval Study

Sponsor

Senseonics, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04836546

Collaborator

(none)

925

Enrollment

Locations

Arm

59.6

Anticipated Duration (Months)

57.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Device: Blood glucose meter Device: Eversense CGM System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

925 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 13, 2021

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self monitoring of blood glucose, then CGM System All 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	Device: Blood glucose meter First phase: SMBG for 6 months Device: Eversense CGM System Second phase: CGM for 6 months

Arm

Intervention/Treatment

Experimental: Self monitoring of blood glucose, then CGM System

All 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

Device: Blood glucose meter

First phase: SMBG for 6 months

Device: Eversense CGM System

Second phase: CGM for 6 months

Outcome Measures

Primary Outcome Measures

Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events [First 6 months (phase 1) compared to second 6 months (phase 2)]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LA Universal Research Center, Inc.	Los Angeles	California	United States	90057
2	Denver Endocrinology, Diabetes & Thyroid Center	Englewood	Colorado	United States	80113
3	CMR of Greater New Haven	Hamden	Connecticut	United States	06517
4	Chase Medical Research	Waterbury	Connecticut	United States	06708
5	The Center for Diabetes and Endocrine Care	Fort Lauderdale	Florida	United States	33312
6	Miami Lakes Clinical Trials INC	Miami Lakes	Florida	United States	33014
7	MedCare Research	Miami	Florida	United States	33165
8	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
9	Rocky Mountain Clinical Research	Idaho Falls	Idaho	United States	83404
10	MODEL Clinical Research	Baltimore	Maryland	United States	21204
11	Southern Maryland Medical Group	Camp Springs	Maryland	United States	20746
12	Metro Detroit Endocrinology	Dearborn	Michigan	United States	48126
13	Diabetes and Endocinology Specialists, Inc.	Chesterfield	Missouri	United States	63017
14	Southwest Family Medicine Associates	Dallas	Texas	United States	75235
15	Javara, Inc	Houston	Texas	United States	77095
16	Green Mountain Research Institute	Rutland	Vermont	United States	05701

Sponsors and Collaborators

Senseonics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Senseonics, Inc.

ClinicalTrials.gov Identifier:

NCT04836546

Other Study ID Numbers:

CTP-0039

First Posted:

Apr 8, 2021

Last Update Posted:

Jun 16, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Senseonics, Inc.

Type 1 Diabetes

Type 2 Diabetes

Study Results

No Results Posted as of Jun 16, 2022