New York, NY—The Leona M. and Harry B. Helmsley Charitable Trust today announced a new $5,025,099 grant to the Jaeb Center for Health Research Foundation to evaluate the efficacy of a virtual specialty clinic model for improving clinical and psychosocial outcomes for people with diabetes. This clinical trial will include remote onboarding of continuous glucose monitoring (CGM), insulin dosing support, and mental health support.

Largely due to geography, many people with diabetes in the U.S. lack access to an endocrinologist who can provide expert guidance that can lead to better outcomes. As a result, they may not have access to up-to-date advancements in devices that have been shown to be beneficial for people with diabetes CGM is proven to reduce average blood glucose levels, as well as severe hypoglycemia and diabetic ketoacidosis. Ensuring access to specialty care is possible with advances in diabetes care technology, and the goal of this study is to see if access to virtual specialty care that includes introduction to CGM can improve outcomes.

In January 2019, Helmsley funded the Jaeb Center’s pilot study to assess whether CGM could be successfully introduced outside of a clinic. Over three months, Certified Diabetes Care and Education Specialists (CDCESs) from Cecelia Health remotely onboarded 34 individuals who were new to CGM and received their diabetes care from their PCP. The results, presented at the 2020 International Conference on Advanced Technologies & Treatments for Diabetes and published in the Journal of the Endocrine Society, showed that every participant used CGM for the full study and the personalized support enabled them to improve their glycemic outcomes and quality of life.

The more robust study taking place at the Jaeb Center under the new grant will also include CGM-naïve individuals receiving diabetes care from their PCP but will engage 300 individuals with types 1 and 2 diabetes nationwide for six months. In addition to help with remote CGM onboarding, a virtual clinic team including CDCESs from Cecelia Health will provide insulin dosing advice. The team of Cecelia Health will be using the DreaMed Advisor Platform which will include a comprehensive data system that can pull information from CGM, SMBG, insulin pumps and connected insulin pens, visualized it for the healthcare provider and for the participants through web and mobile application as well as operate decision support algorithms to optimize insulin treatment plan for people with type 1/type 2 on insulin pumps or multiple daily injections therapy. To address the prevalence of mental health issues in people with diabetes, the virtual clinic team will include licensed psychologists and behavioral health coaches who can lend support to participants to address diabetes-related challenges. The study will evaluate CGM use over time, glycemic- and participant-reported outcomes, healthcare utilization and cost, use of decision support tools, and assess the need and impact of mental health services.

“Geography shouldn’t dictate outcomes, and the Virtual Specialty Clinic is an innovation that can improve outcomes for people with diabetes no matter where they live,” said David Panzirer, a Helmsley Trustee. “We’re hopeful that the data from this larger study will prove the value of VDiSC to commercial entities and health insurance companies in improving clinical and psychosocial outcomes for people with T1D.”

“CGM has advanced to where it should be considered part of the standard care for all adults and children with type 1 diabetes. This project will expand access to this technology to individuals who have not had the opportunity to use CGM,” said Roy W. Beck, MD, PhD, Executive Director of the Jaeb Center for Health Research.

In addition to Cecelia Health’s team of CDCESs, licensed psychologists and behavioral health coaches, subcontractors on the grant to Jaeb include DreaMed Diabetes, which will provide the data management and decision support software, and a national payer, which will help with the recruitment of participants from among its members and help with the analysis of data and health economics outcomes.

“We are thrilled to be involved in the evaluation of a Virtual Diabetes Specialty Clinic Model supported by Helmsley,” said Eran Atlas, CEO of DreaMed Diabetes.

“We’re looking forward to enhancing even further the significant improvements we empowered participants to achieve in their glycemic outcomes and quality of life in the pilot study,” said David Weingard, CEO and Founder of Cecelia Health.

This announcement follows the unveiling of findings from the Helmsley-funded Jaeb Center projects, CITY (CGM Intervention in Teens and Young Adults With Type 1 Diabetes) and WISDM (Wireless Innovation for Seniors With Diabetes Mellitus) studies, which showed that while CGM can improve outcomes, personalized support is needed to ensure that patients truly benefit. Aligning with Helmsley’s commitment to data sharing, results will be shared by the Jaeb Center within twelve months after trial conclusion, and by December 2022, at clinicaltrials.gov and vivli.org.

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About the 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 $2.5 billion for a wide range of charitable purposes. The Helmsley Type 1 Diabetes Program is the one of the largest private foundation funders of T1D in the nation focused on understanding the disease, developing better treatments, and improving care and access. For more information on Helmsley and its programs, visit helmsleytrust.org.

About the Jaeb Center for Health Research

The mission of the Jaeb Center for Health Research in Tampa, Florida is to expand scientific knowledge and improve public health by designing and conducting world-class clinical trials and epidemiologic research.  Established in 1993 as a freestanding, nonprofit coordinating center , the Jaeb Center’s focus is on projects involving eye disorders or diabetes. For more information, please visit www.jaeb.org. 

Contact:

Regina Palatini, rpalatini@helmsleytrust.org, 212.953.2879