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PAS: Post Approval Study of the Eversense® Continuous Glucose Monitoring

Sponsor
Senseonics, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03908125
Collaborator
(none)
273
Enrollment
17
Locations
1
Arm
47.4
Anticipated Duration (Months)
16.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Eversense® CGM system
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
273 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System
Actual Study Start Date :
Mar 19, 2019
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Continuous Glucose Monitoring Device

Device: Eversense® CGM system
Continuous Glucose monitoring device that lasts up to 90 days

Outcome Measures

Primary Outcome Measures

  1. Incidence of procedure-related adverse events [12 months]

    The primary safety endpoint is the Incidence of the composite of infection, secondary procedures to remove the sensor, or procedure-related adverse events of at least moderate severity

  2. Time in Range [12 months]

    The primary effectiveness endpoint is Time in Range, which is defined as glucose values between 70mg/dL and 180 mg/dL, at 12 months post first sensor insertion compared to first month post first sensor insertion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Subject has diabetes

  2. Subject is greater than 18 years of age

Exclusion Criteria:

  1. Subject is critically ill or hospitalized

  2. Subject has a known contraindication to dexamethasone or dexamethasone acetate

  3. Subjects requiring intravenous mannitol or mannitol irrigation solutions

  4. Female subjects who are pregnant, planning on becoming pregnant or nursing

  5. Subjects on hybrid closed loop systems or closed loop systems

  6. Subjects on other CGM systems

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center Newport Beach California United States 92663
2 Denver Endocrinology, Diabetes & Thyroid Center Englewood Colorado United States 80113
3 The Center for Diabetes and Endocrine Care Fort Lauderdale Florida United States 33312
4 Atlanta Diabetes Associates Atlanta Georgia United States 30318
5 MODEL Clinical research Baltimore Maryland United States 21204
6 Metro Detroit Endocrinology Center Dearborn Michigan United States 48126
7 Diabetes and Endocrinology Specialists, Inc. Chesterfield Missouri United States 63017
8 Albany Medical College Albany New York United States 12206
9 Physicians East Greenville North Carolina United States 27834
10 Wilmington Health/PMG Wilmington North Carolina United States 28401
11 Diabetes & Endocrinology Consultants of Pennsylvania, LLC Feasterville Pennsylvania United States 19053
12 AM Diabetes & Endocrinology Bartlett Tennessee United States 38133
13 Texas Diabetes and Endocrinology Austin Texas United States 78731
14 Clinical Research Solution, LLC Cypress Texas United States 77433
15 Javara, Inc. Houston Texas United States 77095
16 Diabetes and Glandular Disease Clinic San Antonio Texas United States 78229
17 Consano Clinical Research, Diabetes and Metabolism Specialists Shavano Park Texas United States 78231

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:
NCT03908125
Other Study ID Numbers:
  • CTP-0034
First Posted:
Apr 9, 2019
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Apr 1, 2022