ACTIVE_NOT_RECRUITING

Eversense® Non-adjunctive Use Post Approval Study

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Conditions

DiabetesType 1 DiabetesType 2 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-13
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04836546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject has diabetes
  2. 2. Subject is ≥18 years of age
  3. 3. Subject has a smartphone that is internet enabled
  4. 4. Subject is able to comply with study protocol tasks and understand written and verbal instructions in the investigator's opinion
  5. 5. Subjects is willing and able to provide written signed and dated informed consent
  1. 1. Subject is critically ill or hospitalized
  2. 2. Prior use of CGM defined as:
  3. * No more than 1 week of continuous CGM use in the last 6 months, and
  4. * At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.
  5. 3. Subject has a known contraindication to dexamethasone or dexamethasone acetate
  6. 4. Subjects requiring intravenous mannitol or mannitol irrigation solutions
  7. 5. Subject is on dialysis at the time of enrollment
  8. 6. Female subjects who are pregnant, planning on becoming pregnant or nursing

Contacts and Locations

Study Locations (Sites)

LA Universal Research Center, Inc.
Los Angeles, California, 90057
United States
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, 80113
United States
CMR of Greater New Haven
Hamden, Connecticut, 06517
United States
Chase Medical Research
Waterbury, Connecticut, 06708
United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
United States
Miami Lakes Clinical Trials INC
Miami Lakes, Florida, 33014
United States
MedCare Research
Miami, Florida, 33165
United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Tandem Clinical Research
Marrero, Louisiana, 70072
United States
Southern Maryland Medical Group
Camp Springs, Maryland, 20746
United States
Metro Detroit Endocrinology
Dearborn, Michigan, 48126
United States
Diabetes and Endocinology Specialists, Inc.
Chesterfield, Missouri, 63017
United States
Endocrine Associates of West Village
Long Island City, New York, 11101
United States
Physician's East Endocrinology
Greenville, North Carolina, 27834
United States
Superior Clinical Research
Smithfield, North Carolina, 27577
United States
AM Diabetes & Endocrinology
Bartlett, Tennessee, 38133
United States
Texas Diabetes and Endocrinology
Austin, Texas, 78749
United States
Southwest Family Medicine Associates
Dallas, Texas, 75235
United States
Clinical Research Solution Institute
Houston, Texas, 77095
United States
RGV Endocrine Center
McAllen, Texas, 78503
United States
Green Mountain Research Institute
Rutland, Vermont, 05701
United States

Collaborators and Investigators

Sponsor: Senseonics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-13
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-04-13
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Type 1 Diabetes
  • Type 2 Diabetes

Additional Relevant MeSH Terms

  • Diabetes