Gainesville, Florida 32608

  • Diabetes

Purpose:

Evaluate safety of non-adjunctive CGM use in CGM naive participants.


Study summary:

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 (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.


Criteria:

Inclusion Criteria: - Naïve to real-time CGM - Type 1 or insulin-requiring Type 2 diabetes - ≥ 2 years old Exclusion Criteria: - 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


NCT ID:

NCT03340831


Primary Contact:

Study Director
David Price, MD
Dexcom-Medical Affairs

Stayce Beck, PhD, MPH
Phone: 8582036454
Email: stayce.beck@dexcom.com


Backup Contact:

Email: nelly.njeru@dexcom.com
Nelly Njeru
Phone: 8582036379


Location Contact:

Gainesville, Florida 32608
United States

Janey Adams
Email: janey.adams@peds.ufl.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2021

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