Status:
UNKNOWN
Continuous Monitoring and Control of Hypoglycemia
Lead Sponsor:
DexCom, Inc.
Conditions:
Diabetes
Eligibility:
All Genders
2+ years
Brief Summary
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
Detailed Description
The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information...
Eligibility Criteria
Inclusion
- Naïve to real-time CGM
- Type 1 or insulin-requiring Type 2 diabetes
- ≥ 2 years old
Exclusion
- Use of RT-CGM, within the past 12 months
- 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
Key Trial Info
Start Date :
October 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
1388 Patients enrolled
Trial Details
Trial ID
NCT03340831
Start Date
October 20 2017
End Date
December 30 2023
Last Update
September 21 2021
Active Locations (25)
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1
Scripps Whittier Diabetes Institute
La Jolla, California, United States, 92037
2
Diabetes and Endocrine Associates
La Mesa, California, United States, 91942
3
Centre of Excellence in Diabetes and Endocrinology
Sacramento, California, United States, 95821
4
Mills-Peninsula Medical Center
San Mateo, California, United States, 94401