Delaware law runs a volunteer study of diabetes care

The law provides for a study that tracks participants’ health and lets care teams use technology to guide their care. The study is for volunteer patients with diabetes and their physicians, working with physician-led care teams. The Secretary must select a technology company, and 400 to 500 volunteers must be recruited before the study is implemented. The law takes effect immediately. The study must be implemented 90 days after the Secretary selects a technology company and 400 to 500 volunteers have been recruited.

The Secretary must recruit volunteers, and care teams must make a health plan for each admitted patient. The study targets 400 to 500 volunteers with Type 2 diabetes and includes at least 200 similar patients whose identities are hidden for comparison. Patients must have an A1c result from 6.5% through 10.0% to be admitted. The Secretary must make a reasonable effort to recruit a group that reflects Delawareans with Type 2 diabetes. If fewer than 400 volunteers enroll, the Secretary may open the study to qualified volunteers and their physicians through health plans. Information used by the study must comply with federal health privacy law. Care teams compare participants’ health data every three months, and repeat laboratory tests every six months.

The Delaware Health Information Network must report study results, and the study ends unless lawmakers extend it. Reports go to the Secretary, Governor, and General Assembly. If results are significantly positive, the Secretary may end the study and expand the program. The first report is due six months after implementation, with further reports every six months. The study ends three years after implementation unless extended by law.