RecruitingType 1 DiabetesType 2 Diabetes

Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes

Eligible age

2–80 yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.

Sponsor: Medtronic MiniMed, Inc.

✓ 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 to read the language offered in the study materials.
✓ 4. Is willing to provide informed consent/assent for participation.
✓ 5. If participating in BGA FST, has adequate venous access as assessed by investigator or appropriate staff.
✓ 6. Is willing to perform fingerstick blood glucose measurements as needed.

✕ 1. Unable to consent due to a mental or intellectual disability.
✕ 2. Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.
✕ 3. Has had a hypoglycemic seizure within the past 6 months prior to screening visit.
✕ 4. Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
✕ 5. Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.
✕ 6. T2D: Has had hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
✕ 7. Has a history of a seizure disorder.
✕ 8. Has a central nervous system or cardiac disorder resulting in syncope.