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Eversense® Non-adjunctive Use Post Approval Study (NA-PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04836546
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : June 16, 2022
Sponsor:
Information provided by (Responsible Party):
Senseonics, Inc.

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 13, 2021
Estimated Primary Completion Date : March 31, 2026
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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




Primary Outcome Measures :
  1. Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836546


Contacts
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Contact: Pamela Mann, RN 240-778-6164 pamela.mann@senseonics.com
Contact: Katherine Tweden, PhD katherine.tweden@senseonics.com

Locations
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United States, California
LA Universal Research Center, Inc. Recruiting
Los Angeles, California, United States, 90057
Contact: Maximo Tacuchi    213-359-9091    drmaxt@launiresearch.com   
Contact: Tatyana Palmer       TatyanaCRC10@launiresearch.com   
Principal Investigator: Bruce Torkan, MD         
United States, Colorado
Denver Endocrinology, Diabetes & Thyroid Center Recruiting
Englewood, Colorado, United States, 80113
Contact: Stacey Mitchell, CRC    303-321-2644    Stacey.Mitchell@denverendocenter.com   
Contact: Amanda Hang, CRC    3033212644 ext 214    Amanda@denverendocenter.com   
Principal Investigator: Lori Gerard, MD         
Sub-Investigator: Linda Buckley, MD         
United States, Connecticut
CMR of Greater New Haven Recruiting
Hamden, Connecticut, United States, 06517
Contact: Melissa Capasso    203-490-2077    mcapasso@chasemr.com   
Principal Investigator: Joseph Soufer, MD         
Chase Medical Research Recruiting
Waterbury, Connecticut, United States, 06708
Contact: Amanda Aliu    203-721-6040    aaliu@chasemr.com   
Principal Investigator: Joseph Soufer, MD         
United States, Florida
The Center for Diabetes and Endocrine Care Recruiting
Fort Lauderdale, Florida, United States, 33312
Contact: Carrie-Ann Silvia    954-963-7191 ext 243    csilvia@diabetes-endocare.com   
Contact: Maria Martin    954-963-7100 ext 236    mmartin@diabetes-endocare.com   
Principal Investigator: Sam Lerman, MD         
Miami Lakes Clinical Trials INC Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Nayribis Vargas, BS    305-621-8051    nvargas@sunctrials.com   
Principal Investigator: Barry M Kotler, MD         
MedCare Research Recruiting
Miami, Florida, United States, 33165
Contact: Daniela Urra       durra@medcareresearch.com   
Principal Investigator: Adalberto Aguilera, MD         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Betsy Childs    404-355-4393    bchilds@atlantadiabetes.com   
Principal Investigator: Bruce Bode, MD         
United States, Idaho
Rocky Mountain Clinical Research Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: William Hardee    208-522-6005    william.hardee@idahomed.com   
Principal Investigator: David Liljenquist, MD         
United States, Maryland
MODEL Clinical Research Withdrawn
Baltimore, Maryland, United States, 21204
Southern Maryland Medical Group Recruiting
Camp Springs, Maryland, United States, 20746
Contact: Iluyomade Adeusi    301-312-0575    luyomade@marylandresearchcenters.com   
United States, Michigan
Metro Detroit Endocrinology Recruiting
Dearborn, Michigan, United States, 48126
Contact: Ahmad Ghamlouche, BS    313-203-5300 ext 3050    Ahmad1mdec@gmail.com   
Principal Investigator: Ayman Elkadry, MD         
United States, Missouri
Diabetes and Endocinology Specialists, Inc. Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Suzette Christopher, CRC    314-469-6224 ext 226    metabnet@aol.com   
Principal Investigator: Ralph Oiknine, MD         
United States, Texas
Southwest Family Medicine Associates Recruiting
Dallas, Texas, United States, 75235
Contact: Lashonda Brown    469-893-1242    lashonda@southwestfamilymed.com   
Principal Investigator: Chrisette Dharma, MD         
Javara, Inc Withdrawn
Houston, Texas, United States, 77095
United States, Vermont
Green Mountain Research Institute Recruiting
Rutland, Vermont, United States, 05701
Contact: Desiree Delgado Chamorro    802-855-8368    desiree@greenmountainresearch.org   
Principal Investigator: Hurtado, MD         
Sponsors and Collaborators
Senseonics, Inc.
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Responsible Party: Senseonics, Inc.
ClinicalTrials.gov Identifier: NCT04836546    
Other Study ID Numbers: CTP-0039
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Senseonics, Inc.:
Type 1 Diabetes
Type 2 Diabetes