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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UNKNOWN
1388 participants
OBSERVATIONAL
2017-10-20
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CGM/BGM Group
single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA).
Continuous Glucose Monitoring (CGM)
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)
Interventions
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Continuous Glucose Monitoring (CGM)
Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)
Eligibility Criteria
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Inclusion Criteria
* Type 1 or insulin-requiring Type 2 diabetes
* ≥ 2 years old
Exclusion Criteria
* Pregnancy
* Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy.
* Known (or suspected) significant allergy to medical grade adhesives
* Dialysis
2 Years
ALL
No
Sponsors
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DexCom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Price, MD
Role: STUDY_DIRECTOR
Dexcom-Medical Affairs
Locations
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Scripps Whittier Diabetes Institute
La Jolla, California, United States
Diabetes and Endocrine Associates
La Mesa, California, United States
Centre of Excellence in Diabetes and Endocrinology
Sacramento, California, United States
Mills-Peninsula Medical Center
San Mateo, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
University of Florida Pediatric Endocrinology
Gainesville, Florida, United States
Intervent Clinical Research Center
Pembroke Pines, Florida, United States
University of South Florida Clinical Research Center
Tampa, Florida, United States
Atlanta Diabetes
Atlanta, Georgia, United States
Rocky Mountain Diabetes Center
Idaho Falls, Idaho, United States
Northshore University Health System
Skokie, Illinois, United States
Iowa Diabetes & Endocrinology Research Center
Des Moines, Iowa, United States
Cotton O'Neil Clinical Research
Topeka, Kansas, United States
International Diabetes Research Center
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Methodist Physicians Clinic - Diabetes and Endocrine Specialists
Omaha, Nebraska, United States
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, United States
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology
Oklahoma City, Oklahoma, United States
Vanderbilt Eskind Diabetes Clinic
Nashville, Tennessee, United States
Amarillo Medical Specialists, LLP
Amarillo, Texas, United States
Texas Diabetes and Endocrine
Austin, Texas, United States
Research Institute of Dallas
Dallas, Texas, United States
Advanced Research Associates
Ogden, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PTL-901895
Identifier Type: -
Identifier Source: org_study_id
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