About the study

This research study is testing an investigational automated insulin system that is worn only at night. It works with a continuous glucose monitor (CGM) to deliver small amounts of rapid-acting insulin under the skin during sleep. It does not replace long-acting, mealtime or daytime correction insulin. The system is investigational, which means the FDA has not cleared it for sale.

Taking part lasts about 8 weeks, including screening and a final visit: 7 days wearing a CGM with usual care, then three supervised nights using the study system at a place the study arranges (such as a clinic or hotel), then up to 45 nights using it at home, with a visit to the research site partway through. Participants also wear a study-provided smart ring and use study apps on a study-provided phone.

Taking part is voluntary. The research site explains the study, including its risks, before anyone decides to join. Participants are compensated for their time.

Sponsor: Luna Health, Inc. This website is operated on the sponsor’s behalf to help people find out whether they may qualify. It does not provide medical advice or care.

IRB approval number: pending.

Contact the study team: Sansum Diabetes Research Institute, (805) 682-7638.