An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the community-derived OS-AID Loop System on adults with type 2 diabetes.
The study will include adults with type 2 diabetes in the United States, with a recruitment goal of a maximum of 100 participants. Data to be collected to address the study objective will include CGM metrics; HbA1c; insulin delivery data; carbohydrate data; activity data from HealthKit; self-reported adverse events (e.g., severe hypoglycemia, diabetic ketoacidosis, hospitalizations); self-reported device issues; and user experience/treatment satisfaction surveys. Follow-up data will be collected on a monthly basis as long as the study is continuing and participants are still using Loop.
Study Type
OBSERVATIONAL
Enrollment
8
The Loop System consists of an insulin pump and a Dexcom CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.
Jaeb Center for Health Research
Tampa, Florida, United States
Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
Number of DKA events and event outcomes. DKA events are defined as hospitalization with documentation of arterial blood pH \<7.30 or venous pH \<7.24 or serum bicarbonate (or CO2) \<15.
Time frame: Up to 3 months
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
Number of severe hypoglycemic events and event outcomes. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.
Time frame: Up to 3 months
Measure of Loop Safety by Self-Report of Hospitalization Events
Number of hospitalizations
Time frame: Up to 3 months
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