The Loop 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 Loop DIY automated insulin delivery system.

Detailed Description
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The study will include both adults and youth in the United States, with a recruitment goal of at least 300-1,250 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 psychosocial and user experience/treatment satisfaction surveys. Online forms will allow participants to report weekly device issues and serious adverse events including severe hypoglycemia, diabetic ketoacidosis, and hospitalizations. General data updates will be obtained after three, six, and 12 months (and every six months thereafter if study participation continues). A fingerstick blood sample will be collected for HbA1c measurement after three months for cohort A and after six and 12 months for both cohorts. Quality-of-life/psychosocial and treatment satisfaction questionnaires will be completed after six and 12 months; new users also will complete questionnaires after 3 months. Virtual focus groups will be completed within the first three months of starting Loop and at 12 months.

Official Title
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An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Loop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes Currently have, or have ordered, the hardware devices necessary to use Loop Currently use Loop or have plans to start using Loop for insulin delivery Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data and complete questionnaires that are part of the protocol Resident of U.S. Exclusion Criteria: None
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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Individuals who have not started Loop or who have been on Loop fewer than 7 days at the time of enrollment. | Device: Loop<br>* The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic 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.<br>|
| Cohort B<br>Participants who have been using Loop 7 or more days at the time of enrollment. | Device: Loop<br>* The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic 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.<br>|

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 on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider. | 6 Months | 
| Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events | Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. 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. | 6 Months | 
| Measure of Loop Safety by Self-Report of Hospitalization Events | Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey. | 6 Months | 

Secondary 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 on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider. | 12 Months | 
| Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events | Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. 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. | 12 Months | 
| Measure of Loop Safety by Self-Report of Hospitalization Events | Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Loop, RileyLink, Type 1 Diabetes