Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT05951569
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.
Study:
NCT05951569
Study Brief:
Protocol Section:
NCT05951569