Loop T2D Observational Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Observational Study of Adults With Type 2 Diabetes Using the Community-Derived Open-Source Automated Insulin Delivery Loop System

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Community-Derived Open-Source Automated Insulin Delivery Loop System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Community-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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 3 months | 
| Measure of Loop Safety by Self-Report of Hospitalization Events | Number of hospitalizations | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loop, Type 2 Diabetes, Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Autoimmune Diseases, Immune System Diseases