PORTLAND, Oregon — To help the estimated 1.45 million Americans living with type 1 diabetes better manage their blood sugar levels, Oregon Health & Science University is combining the power of an artificial intelligence-driven smartphone app with the support of human experts.
The Leona M. and Harry B. Helmsley Charitable Trust has awarded OHSU more than $4.3 million to support this work. Leading the project are OHSU biomedical engineer Peter G. Jacobs, Ph.D., and OHSU endocrinologist Leah M. Wilson, M.D., who are organizing a randomized clinical trial to evaluate the impact of using their enhanced app in concert with diabetes education specialists.
People with type 1 diabetes cannot regulate their own blood sugar levels, and so they must take the drug insulin throughout the day. Diabetes that isn’t controlled well can lead to serious complications, such as heart and kidney disease, nerve damage, vision and hearing loss, coma or even death.
To help those who manage type 1 diabetes by giving themselves insulin injections several times a day, Jacobs, Wilson and colleagues developed the DailyDose app, which uses an artificial intelligence, or AI, algorithm to evaluate blood sugar data, identify concerning trends and recommend steps to help patients keep their glucose levels within a healthy range.
During the last decade, federal approval of smaller, wearable technologies like continuous glucose monitors and automated insulin delivery systems have made type 1 diabetes management easier. But insulin delivery devices — which can cost thousands of dollars, depending on the model and insurance coverage — are out of financial reach for many patients. And while the number of diabetes apps have grown dramatically in recent years, none offer recommendations on how to modify insulin doses or behaviors like DailyDose.
Jacobs, Wilson and others published a 2020 study that showed their app’s recommendations largely matched those of physicians who specialize in diabetes care. In November 2022, the team published a follow-up study that found blood sugar levels significantly improved when people followed the app’s recommendations, but those who followed the app’s recommendations less often didn’t have similar benefits.
“Our recent study found that some people didn’t accept the recommended changes provided by the app because they didn’t understand how the recommendations would improve their glucose management, or because they mistakenly thought that making the recommended changes would negatively impact their health,” said Jacobs, an associate professor in the Department of Biomedical Engineering, OHSU School of Medicine.
“We also found that other barriers prevented some people from making changes to their glucose management,” Jacobs added. “For example, if you’re under a lot of stress or if you work multiple jobs, managing your glucose and taking the time to do something new can seem overwhelming or even impossible.”
To nudge more people toward acting on the app’s recommendations, the research team is taking a two-pronged approach: first, they’re updating the app so it uses new glucose forecasting algorithms and an improved user interface, which should make its recommendations more transparent and easier to understand; and, second, the app will connect those who aren’t able to improve their glucose control using the app alone with a diabetes educator or behavioral health clinician to help them overcome challenges that prevent them from making changes.
The clinical trial will first have participants use the DailyDose app, and only have them also receive coaching from a diabetes educator if necessary, because, while effective, one-on-one education can be costly and time-consuming. Researchers designed the approach to be affordable and scalable.
The multicenter clinical trial will follow a total of 93 people with type 1 diabetes for 38 weeks. After the first 12 weeks, study participants who do not benefit from using the app alone will also be connected with a diabetes educator or a psychologist. The OHSU team is also developing an online coaching platform that is designed to work with DailyDose to further help the diabetes educators and psychologists support the study participants.
“Some people struggling with glucose management may benefit from personalized coaching,” said Wilson, an assistant professor in the Department of Medicine, Division of Endocrinology, Diabetes and Clinical Nutrition, OHSU School of Medicine. “But, knowing that coaching is resource-intensive, our study will only offer it to those who need it. We call this combined approach app-based certified diabetes education therapy, or AB-CDE.”
The study will enroll participants beginning in 2024 through six institutions: Harold Schnitzer Diabetes Health Centerat OHSU, Joslin Diabetes Center at Harvard University, University of Southern California, University of California San Diego, Mount Sinai Hospital and Barbara Davis Center for Diabetes at the University of Colorado.
“Decision support, like that provided through the DailyDose app, greatly improves access to quality diabetes care, regardless of where people live,” said Sean Sullivan, Ph.D., a program officer at the Helmsley Charitable Trust. “For many, however, an app is simply not enough. This project will evaluate who benefits most from app-based decision support, and who might require the additional personal touch of a diabetes education and behavioral health specialist. Ultimately, we hope this project will improve care for all with type 1 diabetes, and make managing the disease in their daily lives easier.”
The new clinical study is being supported by the Leona M. and Harry B. Helmsley Charitable Trust. The study published in November 2022 was supported by the Leona M. and Harry B. Helmsley Charitable Trust, Oregon Medical Research Foundation (No. AEDCN0362) and the National Institute of Diabetes and Digestive and Kidney Diseases (grant 1R01DK120367).
In the interest of ensuring the integrity of our research and as part of our commitment to public transparency, OHSU actively regulates, tracks and manages relationships that our researchers may hold with entities outside of OHSU. In regards to this research, Jacobs has significant interest in Pacific Diabetes Technologies, Inc., a company that may have a commercial interest in the results of this research and technology. Review details of OHSU's conflict of interest program to find out more about how we manage these business relationships.
Related OHSU News stories:
- New algorithm uses artificial intelligence to help manage type 1 diabetes (June 12, 2020)
- Type 1 Diabetes Facts (JDRF)
- Diabetes (CDC)
- Jacobs Lab – Artificial Intelligence for Medical System Lab (OHSU)
- OHSU Harold Schnitzer Diabetes Health Center (OHSU)
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