(Amanda Mills, CDC.gov)
2 May 2019. A device to rescue people with diabetes experiencing low blood sugar is being developed by an Indiana company and Purdue University pharmacy lab. The technology is funded by a 2-year, Small Business Innovation Research, or SBIR grant of up to $1.4 million from National Institute of Diabetes and Digestive and Kidney Diseases, part of National Institutes of Health.
The device is designed to help people with hypoglycemia, a condition encountered often by people with diabetes, whose blood glucose levels fall too low. Diabetes is a chronic disorder where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for at least 90 percent of all diabetes cases, the pancreas produces some but not enough insulin, or the body cannot process insulin.
People with diabetes need to regularly measure their blood glucose level and take insulin to bring that level down to a safe range. If due to miscalculation or other reasons too much insulin is injected, hypoglycemia occurs where that level falls to an unsafe level. When that happens, symptoms occur like sweating, shaking, irregular heartbeat, and fatigue. If left untreated, more serious symptoms can occur such as confusion, seizures, or loss of consciousness.
Treatment of hypoglycemia can be a simple intake of high-sugar food or drink, as well as tablets and gels, but continued episodes may require a more direct therapy. That therapy uses glucagon, a hormone produced in the pancreas that works with insulin to keep blood glucose levels in a safe range. Rescue kits with glucagon are available, but require mixing dried glucagon in a syringe and injecting the person with hypoglycemia. Those steps are often difficult to perform in a hypoglycemic state, for both individuals and caregivers.
The team of Purdue University pharmacy professor Elizabeth Topp in West Lafayette, Indiana and the company Monon Bioventures in Indianapolis are developing an easy-to-use hypoglycemia rescue kit. Current rescue kits use dried glucagon, since the hormone in its natural state is unstable and poorly soluble. Topp’s lab at Purdue studies the stability of protein compounds, and developed a synthetic and more stable derivative of the hormone called phospho-glucagon that reverts to natural glucagon in the body.
Monon Bioventures provides the business and technical infrastructure for academic life science labs to convert their discoveries into marketable products. For this task, Monon proposes creating a hypoglycemia rescue kit with ready-to-use phospho-glucagons from Topp’s lab. The SBIR grant to Monon funds preclinical development of a hypoglycemia rescue kit that allows users to immediately inject or inhale the synthetic glucagon. The project’s final deliverable is an assessment of the product’s long-term stability, chemical activity in the body, and safety.
The company received a fast-track award from NIH to develop the rescue kit. SBIR grants are usually divided between phase 1 awards that first determine the technical and commercial feasibility of the technology, and phase 2 to create a prototype, or for biomedical applications, complete preclinical testing. Topp’s lab already conducted tests of phospho-glucagons with lab animals, enabling the single fast-track award to Monon combining the 2 phases, but still requiring achievement of performance milestones.
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