Diabetes Mellitus, Type 2
Conditions
Keywords
Loop, Type 2 Diabetes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases
Brief summary
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.
Detailed description
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.
Interventions
DEVICECommunity-Derived Open-Source Automated Insulin Delivery Loop System
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.
Sponsors
Embecta Medical
Tidepool Project
Jaeb Center for Health Research
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes * Age ≥18 years old * Currently using any version of Loop other than v3.0.0 or planning to start using any version of Loop other than v3.0.0 Loop within the next 30 days * Willing and able to provide informed consent and to complete surveys and provide the device data that are part of the protocol * Resident of the US * English speaking/reading * Access to email/phone
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events | Up to 3 months | 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. |
| Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events | Up to 3 months | 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. |
| Measure of Loop Safety by Self-Report of Hospitalization Events | Up to 3 months | Number of hospitalizations |
Other
| Measure | Time frame | Description |
|---|---|---|
| Loop T2D Baseline General Data Collection | Enrollment | Self-report participant's basic information. No scale provided, variable responses. |
| Loop T2D Follow-up Survey | Monthly up to 3 months | Self-report of participant's use of Loop and Loop related features. No scale provided, variable responses. |
| HbA1c | Enrollment, Monthly up to 3 months | Self-report |
Countries
United States
Outcome results
None listed