Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
925 participants
INTERVENTIONAL
2021-04-13
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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
Blood glucose meter
First phase: SMBG for 6 months
Eversense CGM System
Second phase: CGM for 6 months
Interventions
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Blood glucose meter
First phase: SMBG for 6 months
Eversense CGM System
Second phase: CGM for 6 months
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Senseonics, Inc.
INDUSTRY
Responsible Party
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Locations
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LA Universal Research Center, Inc.
Los Angeles, California, United States
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, United States
CMR of Greater New Haven
Hamden, Connecticut, United States
Chase Medical Research
Waterbury, Connecticut, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
MedCare Research
Miami, Florida, United States
Miami Lakes Clinical Trials INC
Miami Lakes, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Springfield Clinic
Springfield, Illinois, United States
Tandem Clinical Research
Marrero, Louisiana, United States
Southern Maryland Medical Group
Camp Springs, Maryland, United States
Metro Detroit Endocrinology
Dearborn, Michigan, United States
Diabetes and Endocinology Specialists, Inc.
Chesterfield, Missouri, United States
Endocrine Associates of West Village
Long Island City, New York, United States
Physician's East Endocrinology
Greenville, North Carolina, United States
Superior Clinical Research
Smithfield, North Carolina, United States
AM Diabetes & Endocrinology
Bartlett, Tennessee, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Clinical Research Solution Institute
Houston, Texas, United States
RGV Endocrine Center
McAllen, Texas, United States
Green Mountain Research Institute
Rutland, Vermont, United States
Countries
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Other Identifiers
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CTP-0039
Identifier Type: -
Identifier Source: org_study_id
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