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| Name | Class |
|---|---|
| Embecta Medical | UNKNOWN |
| Tidepool Project | UNKNOWN |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-Derived Open-Source Automated Insulin Delivery Loop System | Device | 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. |
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Loop T2D Baseline General Data Collection | Self-report participant's basic information. No scale provided, variable responses. | Enrollment |
| Loop T2D Follow-up Survey | Self-report of participant's use of Loop and Loop related features. No scale provided, variable responses. |
Inclusion Criteria:
Exclusion Criteria:
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Individuals with type 2 diabetes using the community-derived open-source automated insulin delivery Loop system.
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Bauza, PhD, MPH | Jaeb Center for Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaeb Center for Health Research | Tampa | Florida | 33647 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33226840 | Result | Lum JW, Bailey RJ, Barnes-Lomen V, Naranjo D, Hood KK, Lal RA, Arbiter B, Brown AS, DeSalvo DJ, Pettus J, Calhoun P, Beck RW. A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System. Diabetes Technol Ther. 2021 May;23(5):367-375. doi: 10.1089/dia.2020.0535. Epub 2021 Apr 12. | |
| 38386434 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 11, 2024 | |
| Reset | Aug 9, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 11, 2024 | Aug 9, 2024 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
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| Monthly up to 3 months |
| HbA1c | Self-report | Enrollment, Monthly up to 3 months |
| Bauza C, Kanapka LG, Greene E, Lal RA, Arbiter B, Beck RW. Use of the Community-Derived Open-Source Automated Insulin Delivery Loop System in Type 2 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):494-497. doi: 10.1089/dia.2023.0569. Epub 2024 Apr 8. |