Continuous Monitoring and Control of Hypoglycemia

Clinical Trial ID: NCT03340831

Description

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

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

  • Start Date

    2017-10-20

  • Last Updated

    2019-05-22

  • Sponsor

    DexCom, Inc.

  • Condition Name

    Diabetes

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