Medtronic MiniMed, Inc.
This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.
The study is a multi-center, prospective single-arm design without controls for adult and pediatric subjects with T1D or T2D. The study is anticipated to last approximately 24 months from first investigational center initiation to study completion (last subject, last visit completed). The subject's participation from study enrollment to study exit is approximately up to 46 days (including replacement sensor wear and repeat office procedures if needed).
Inclusion Criteria: 1. Age 2-80 years at time of screening. 2. Has a clinical diagnosis of diabetes as stipulated according to the following age group: 1. Age 2-10 years: Has a clinical diagnosis of T1D or T2D as determined via medical record/ source documentation by an individual qualified to make a medical diagnosis. 2. Age 11-80 years: Has a clinical diagnosis of T1D or T2D for 6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis. 3. Subject or parent(s)/ guardian(s)/ caregiver(s) is/are literate and able t…
Disposable Sensor (MMT-5600XNG and MMT-5600X) - labeled as DS5K and referred to as Unity