Welcome to our daily summary of type 1 diabetes (T1D) research highlights from the ADA’s 73rd Scientific Sessions! Each night, we will be posting summaries of notable sessions and presentations. Below are two relevant sessions from Sunday, June 23:
For the past several years, JDRF has placed an increasing priority on the discovery and development of novel markers and imaging techniques to better describe the T1D disease processes. Such tools will permit more efficient research and speed clinical studies by giving earlier and more precise measures of therapeutic effects on the key T1D disease parameters. This session highlighted the growing recognition of the critical role such markers will play in advancing T1D research and clinical studies.
JDRF-supported investigator Kevan Herold, M.D., professor of immunobiology and endocrinology at Yale University, reported on a retrospective analysis of the multiple anti-CD3 studies completed in T1D. While these study results have been unimpressive overall, it is clear that each study contained a group of participants who clearly benefited from the treatment based on changes in their C-peptide levels (called the responder subset). Some of the initial factors common among the responders were younger age, less time since diagnosis and differences in their immunological profiles. Building on this, Carla Greenbaum, M.D., director of the diabetes research program and director of clinical research at Benaroya Research Institute at Virginia Mason, reviewed data showing the significant variability of the disease progression among individuals. This variability makes it difficult to show benefits from a single therapy among a diverse group of participants, Greenbaum said.
Other presenters reported on their use of the JDRF-organized and funded nPOD program samples to begin homing in on new metabolic and immunologic markers that may prove valuable moving forward as important disease markers. The nPOD program continues to prove to be a unique and valuable resource for the T1D research community in ways not originally anticipated.
JDRF-NIH Artificial Pancreas Development Meeting
JDRF and the National Institutes of Health (NIH) organized this annual gathering bringing together all of the top thought leaders and researchers working to develop closed loop artificial pancreas (AP) systems. This year’s meeting featured a progress report from JDRF’s Vice President of Treat Therapies, Aaron Kowalski, Ph.D., followed by a number of panel discussions.
In his progress report, Dr. Kowalski asserted that the past year featured the most exciting advances yet for AP research. Some of the most tangible examples of progress over the last year include the U.S. Food and Drug Administration (FDA) issuing its guidance for outpatient AP trials, the first-ever FDA-JDRF-NIH artificial pancreas workshop, the approval of 16 new clinical studies, and the publication of 32 manuscripts and papers. And most notably for people with T1D, a dramatic increase in outpatient trials using AP technology reporting success. Dr. Kowalski highlighted an outpatient study conducted by Cambridge University in which adolescents used AP systems for three weeks, at home, without medical supervision. In addition to the data that showed success at keeping the participants’ glucose in range, perhaps the most exciting outcome were participant reports of “reassurance,” “peace of mind,” “confidence,” “safety,” “sleep,” “not being awakened by alarms,” and “not having to think about blood sugar.”
According to Dr. Kowalski, the next year should bring even more success stories as more and more outpatient trials move forward. Already, we are seeing more and more AP clinical trial participants sharing their stories and reporting on the life-changing experience of using this technology. JDRF has been at the forefront of this field for several years with its Artificial Pancreas Project and leadership of the JDRF/NIDDK Artificial Pancreas Consortium.
The first topic for the panel debate and discussion was on remote monitoring. There were several points made in support of the inclusion of remote monitoring with AP systems, most revolving around an added safety measure for a new technology. Some argued that remote monitoring should not be required since people currently do not have remote monitoring for their pumps and sensors. Use of remote monitoring has proven valuable during clinical studies to provide an added level of safety assurance and it was thought by some that once used in clinical studies it will become a regulatory requirement for approved products. It was noted that we live in a world increasing linked to remote monitoring and certainly parents with a child on an AP system would find added comfort in a remote monitoring capability.
The second topic presented was “Perspectives on Initial Closed-Loop Products for Day and Nighttime Use.” As recognized in the JDRF proposed plan for the development of AP systems, the initial AP systems limited by current technologies. Current sensor limitations and insulin limitations create real hurdles to fully closed loop systems as initial products. Night time lows is probably the biggest area of benefit from an initial AP system so having predictive low-glucose suspend capabilities will be a big advantage.
The third topic discussed was the challenges and benefits of AP system data standardization. With an increasing number of clinical studies being conducted on AP systems, some degree of standardization was recognized as a benefit to the field to facilitate cross study comparisons. In fact, some members of the JDRF AP Consortium have developed a white paper on recommendations for data standardization to speed advances to the field. Many stressed the need for full data sharing from all clinical studies, something already happening with all JDRF AP studies.
JDRF’s Aaron Kowalski closed the meeting with the observation that this year has been a critical tipping point in the advancement of AP systems development.