Helmsley Charitable Trust Awards Over $12 Million to Projects Aimed at Helping People With Type 1 Diabetes Safely Incorporate Exercise Into Their Daily Lives

Today, The Leona M. and Harry B. Helmsley Charitable Trust announces seven new grants to support research aimed at helping people with type 1 diabetes (T1D) more safely incorporate exercise into their lives. This support, totaling more than $12 million, is a major stride forward in trying to build knowledge in this important area of unmet need for T1D.

Currently, people with T1D must use trial-and-error to keep their blood sugar under control when exercising, because the impact of exercise can be unpredictable. Technologies like continuous glucose monitors (CGMs) can help, but many people with T1D avoid exercise altogether because of the risk of low blood sugar during or after, which can be dangerous. More research and solutions are urgently needed to ease the burden of exercise with T1D management.

"Glycemic variability and exercise in T1D remains a challenge that current diabetes technology solutions are still not equipped to manage adequately, and available clinical guidelines are too complex or hard to follow in the real-world," said Deniz Dalton, a program officer in Helmsley's T1D Program. "The initial work with T1-DEXI data offers an incredible opportunity to expand research in this area. The wide range of projects we're funding will bring us closer to giving people with T1D the tools they need to manage exercise more easily and safely."

The T1D Exercise Initiative (T1-DEXI) data sets provide baseline information for the T1D community to move beyond trial-and-error. It is the largest observational exercise study in people with T1D, conducted by the Jaeb Center for Health Research (JCHR) in collaboration with other T1D investigators. The data sets are publicly available through Vivli, a data-sharing platform that hosts information on a variety of health conditions. Currently, T1-DEXI data is the most requested data set on the platform surpassing other data set requests to date.

Building on the learnings from the T1-DEXI data, Helmsley launched an RFP in late 2022 seeking research projects that can provide people with T1D, and their healthcare providers, practical management solutions for T1D and exercise. Projects will evaluate new education platforms and modules, diabetes device algorithm improvements, new insulins with automated insulin delivery systems, alternatives to carbohydrate intervention in managing exercise and T1D, and other factors that may impact exercise, such as menstruation.

The seven funded projects are:

• DiabetesWise for exercise
  A team led by Dessi Zaharieva, PhD and Korey Hood, PhD, at Stanford University will work to include education around exercise as an integral part of T1D management into the DiabetesWise platform for people with T1D. DiabetesWise provides unbranded and unbiased information for diabetes technologies, and the expansion to include exercise information will allow people with T1D to have easy access to evidence based information helping them improve their quality of life with exercise.
• Educational intervention to support Diabetes Guidance for Exercise (EDGE)
  Robin L. Gal, MSPH, CCRA at the Jaeb Center for Health Research in collaboration with Michael C. Riddell, PhD at York University and Michael Rickels, MD, MS, and Jorge Kamimoto, MD at the Perelman School of Medicine at the University of Pennsylvania will lead a remote study, that will seek to understand if easily accessible, evidence-based education can improve glycemic control for adults with T1D who exercise. Jaeb will develop the modular, multimedia, on-demand education and conduct a clinical study to evaluate its impact. Data from this study will help identify areas of improvement for current T1D exercise guidelines.
• Exercise-specific AID algorithm for T1D
  Yao Qin, PhD, at the University of California, Santa Barbara will lead a team including collaborators from Stanford University, Tidepool, and University of Trento to conduct a clinical trial to help people with T1D maintain their time in range during and after exercise with Automated Insulin Delivery (AID). Current systems are not designed to manage exercise well, and algorithms need to be adjusted to handle glucose variability that can occur with exercise. This project will design and evaluate an exercise-specific AID algorithm. If successful, it could enhance the FDA-cleared Tidepool Loop algorithm, making it more effective in handling exercise.
• Development of a personalized decision support tool using net insulin on board
  Rayhan A. Lal, MD. at Stanford University will lead a team including collaborators from CeADAR's team AI/Machine Learning researchers at University College Dublin under the leadership of Arsalan Shahid, PhD, MBA, and OpenAPS developer Dana Lewis to explore the incorporation of the net insulin-on-board concept and its relationship to exercise management for T1D. The project will also develop a prototype decision support tool to inform pre-exercise decision-making for people with T1D. The prototype will include net insulin on board education and simulations to understand the impact of different types of exercise on glucose outcomes in combination with user behaviors.
• Leveraging new ultra-rapid insulins with AID
  Robin L. Gal, MSPH, CCRA, at the Jaeb Center for Health Research in collaboration with Dr. Riddell, York University and Dr. Rickels, University of Pennsylvania will lead an in-clinic pilot study that will examine the safety and efficacy of new, ultra-rapid insulins (Affrezza and Lyumjev) for better management of exercise induced glucose levels in adults using AID.
• Whey protein to reduce risk of hypoglycemia during exercise with T1D
  Dale Morrison, PhD will lead a study at the University of Melbourne to test whether the use of whey protein, as an alternative to carbohydrate ingestion, during or after exercise will reduce the risk of hypoglycemia for people with T1D. The study will provide practical advice and a potentially cost-effective solution for people with T1D engaging in exercise.
• Impact of Menstruation on glycemic response and exercise
  A team led by Janet Snell-Bergeon, MPH, PhD, at the University of Colorado, Denver will study the impact of menstrual cycles and hormonal birth control on glycemic response and exercise for people with T1D. Additionally, the study will help understand how people can personalize insulin dosing to optimize glucose management during menstrual cycles.

About The Leona M. and Harry B. Helmsley Charitable Trust

The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $4 billion for a wide range of charitable purposes. The Helmsley Type 1 Diabetes (T1D) Program is the largest private foundation funder in the world with a focus on T1D, with more than $1 billion to date committed to transform the trajectory of the disease and to accelerate access to 21st century care, everywhere. For more information on Helmsley and its programs, visit helmsleytrust.org.