Continuous Monitoring and Control of Hypoglycemia

Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management

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.

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