T1D Exchange Presents Data on New Form of Glucagon “Rescue” Treatment for Severe Hypoglycemia

At global ATTD conference, scientists also share new insight on severe hypoglycemia in older adults with type 1 diabetes – an emerging challenge as patients live longer

PARIS, February 18, 2015 – Research from T1D Exchange scientists presented at the Advanced Technologies & Treatments for Diabetes (ATTD) international conference heralds a new approach to glucagon delivery for “rescue” treatment for diabetes-related severe hypoglycemia. Researchers also presented data that sheds light on individuals with type 1 diabetes perhaps most at risk for this potentially fatal complication– the elderly.

Preliminary clinical trial data have demonstrated that a new, user-friendly, needle-free nasal glucagon delivery system is as effective as the traditional injected form of glucagon. Known as Glucagon Nasal Powder and developed by Locemia Solutions it represents a major step in advancing a treatment that has been largely unchanged for roughly 25 years.

“For type 1 patients and the network of people who touch their lives, the risk of severe hypoglycemia is a daily fear compounded by the anxiety of using a needle and possibly fumbling a complicated treatment under intense pressure, such as in the throes of a seizure or heading toward a coma,” said lead investigator Michael R. Rickels, MD, MS, associate professor of medicine at the University of Pennsylvania Perelman School of Medicine. “This is a potentially life-changing advance, clinically and statistically equal to its predecessor, while providing confidence and peace of mind in its ease of use and benefits to all.”

Mild hypoglycemia, generally defined as a blood sugar below 70 mg/dL, is common in individuals who use insulin. In some of these cases, hypoglycemia becomes severe, requiring emergency medical treatment from a third party. The risk increases with duration of diabetes (see more below).

Rapid treatment of severe hypoglycemia has long been dependent on emergency medical services or on caregivers using a glucagon kit that involves reconstituting the medicine prior to injection. Aside from the fear associated with the use of needles by non-medical personnel, the delivery process is subject to human error, often leading to sub-optimal use of an otherwise effective medication, dangerous delays in treatment and use of costly emergency medical services, according to T1D Exchange.

Glucagon Nasal Powder was borne of a call to action from type 1 diabetes patients to modernize injected glucagon. T1D Exchange conducted online surveys of its T1D community Glu to document current glucagon use practices with insulin users and those who touch their lives; that data was presented to the FDA. Through funding provided by Locemia Solutions and The Leona M. and Harry B. Helmsley Charitable Trust, T1D Exchange helped design & conduct two multi-site pivotal clinical studies to evaluate Locemia’s simpler glucagon delivery technology, which will ultimately be administered by caregivers to insulin users in distress.

“This research illustrates the true benefit of the T1D Exchange model in fostering a potential revolution in clinical care of type 1 diabetes,” said Dana Ball, executive director and co-founder of T1D Exchange, a Boston-based nonprofit. Its mission is to accelerate the R&D process via a patient-centric research model that fosters collaboration among patients, physicians, researchers and industry, with a goal of improving care, health outcomes and quality of life.

“Glucagon Nasal Powder is an exciting development, first because it provides a potentially simpler solution for treating severe hypoglycemia for the community of those who may be called upon to perform rescue treatment. Second, it proves that innovative collaborations can circumvent challenges to advancing medical research,” he added.

According to Ball, T1D Exchange is changing the paradigm, by engaging all stakeholders – patients, clinicians, scientists and industry – at the outset, empowering them to fill the knowledge gap and change the way discoveries are made and the disease is treated.

Severe Hypoglycemia in Older Adults: An Under-recognized Problem
T1D Exchange researchers at ATTD also presented findings regarding severe hypoglycemia in older adults, a burgeoning problem identified early on via the T1D Exchange Registry, which has collected clinical and research data from more than 26,000 type 1 diabetes patients.

In the new study, which sought to identify risk factors for severe hypoglycemia in this population, the investigators collected data from 100 individuals with type 1 diabetes over age 60 who have had the disease for at least 20 years and experienced an episode of severe hypoglycemia in the last year. Data were also collected from an age-matched group of 100 type 1 patients who had not experienced severe hypoglycemia in the past three years. The investigators found that tight glycemic control did not explain the high rate of severe hypoglycemia in this group. Rather, “an ominous combination of hypoglycemia unawareness and high glucose variability increased the severe hypoglycemia risk,” they noted.

“Advances in treatment of type 1 diabetes and better disease control are contributing to improved health outcomes for older patients. We are beginning to understand how the disease manifests over a longer lifespan, and this vulnerable population needs special attention,” said Irl B. Hirsch, MD, professor of medicine and Diabetes Treatment and Teaching Chair at the University of Washington School of Medicine. “Unfortunately, many patients with Medicare don’t always have access to the best care and treatment options.”

The researchers noted that patients who’d experienced severe hypoglycemia in the last year spent approximately an hour a day in the hypoglycemic range and were largely unaware – despite more frequent self-blood testing of glucose levels (six times per day on average).

This builds on the early T1D Exchange Registry data that had shown the incidence of seizure and loss of consciousness due to severe hypoglycemia in older adults was significantly more frequent than previously understood.

“Not only is this age group at the greatest risk for severe hypoglycemia requiring emergency intervention, but they also experience the most barriers to obtaining needed test strips and continuous glucose monitoring devices,” added Hirsch. “We hope that these results will lead to more evidence-based research with Medicare patients so that we can help relieve the hypoglycemia burden.”

This study was also supported by the Leona M. and Harry B. Helmsley Charitable Trust.

Abstracts are available upon request. Full manuscripts of both studies are forthcoming.

About T1D Exchange
T1D Exchange, the first program of Unitio, was founded on the premise that finding faster, better therapies for type 1 diabetes (T1D) requires a research model as multi-faceted as the disease itself. T1D Exchange acts as a convener of the thousands of people working to improve patient outcomes already—by connecting them to one another and to the patient community at large. Drawing on decades of research and data that have come before, T1D Exchange aims to be the translational engine that enables the entire T1D ecosystem to collaborate in truly novel ways via the integration of a Clinic Network, Clinic Registry, Biobank, and the online patient/caregiver community, Glu.

About Locemia Solutions
Locemia Solutions is a privately held, specialty diabetes-focused pharmaceutical company committed to bringing innovation to severe hypoglycemia rescue through simple needle-free and injection-free glucagon delivery. Successful severe hypoglycemia rescue requires a community of supporters empowered to perform rescue treatment with confidence. The company is dedicated to driving awareness of the importance of hypoglycemia education, discussion, and preparedness. Locemia wants everyone to be able to help anyone who uses insulin—quickly and easily—deal with severe low blood sugar. Find out more at www.locemia.com.

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 nonprofits and other mission-aligned organizations in health, selected place-based initiatives, and education and human services. Since 2008, when the Trust began its active grantmaking, it has committed more than $1 billion. The Helmsley Type 1 Diabetes Program is the largest private foundation funder of T1D focused on understanding the disease, developing better treatments and improving care and access. For more information, visit www.helmsleytrust.org.