PRimary CarE PrAgmatic, Real World Experience for Automated Insulin Delivery (PREPARE 4 AID) in Patients with Diabetes
Keywords
Type 1 diabetes, type 2 diabetes, automated insulin delivery, CGM, diabetes technology, RCT
Types of Research
FDA clinical trial/Drug/Device
Summary
Automated Insulin Delivery (AID) systems hold tremendous promise to allow more people with insulin-requiring diabetes to achieve glycemic targets.1 This 13-week 2:1 randomized controlled trial aims to learn if an AID system (the iLet® Bionic Pancreas System) can safely improve blood sugar levels in adults with insulin-treated diabetes relative to routine diabetes care. Primary care patients will be randomized to one of two groups (AID or Routine Care (RC)). RC participants will have the opportunity to participate in a 13-week extension phase using the iLet. The primary outcome is HbA1c change at 13 weeks.
1. American Diabetes Association Professional Practice Committee; 7. Diabetes Technology: Standards of Care in Diabetes—2024. Diabetes Care 1 January 2024; 47 (Supplement_1): S126–S144. https://doi.org/10.2337/dc24-S007
Significance
The initiation of the iLet in a real-world setting, among a group of primary care providers with less experience with advanced diabetes technologies can bring this technology within reach of the majority of people with insulin-requiring diabetes, reducing barriers associated with geography, access, ethnicity, race, gender, language, and socioeconomic factors.
Impact
The iLet Bionic Pancreas - a fully automated insulin delivery system - allows more people with insulin-treated diabetes to achieve glycemic targets without requiring considerable patient and staff time. This trial will be the first to study initiation in patients with type 2 diabetes from diverse primary care settings.
Lessons Learned
Coming soon.
Presentations
Westfeldt E, Prince B, Huss K, Kramer E, Putman MS, Sabean A, Ashley A, Greaux E, Wiggins K, Ying J, Zheng H, Weissberg-Benchell J, Shapiro J, Kostiuk M, Oser TK, Oser J, Oser SM. PRimary CarE PrAgmatic, Real World Experience for Automated Insulin Delivery (PREPARE 4 AID) in Patients with Diabetes. 2024 North American Primary Care Research Group (NAPCRG) Annual Conference, Québec City, Québec, Canada | 20-24 November 2024. Also presented at the Colorado Pragmatic Research in Health Conference (COPRH Con), Aurora, CO | 4-5 June 2025.
