Johnson & Johnson’s experimental pump automatically calculated and delivered the correct amount of insulin diabetic patients needed to control their blood sugar at night without their intervention, an early-stage study found.
The research involving 20 adults with Type 1 diabetes focused on the 9 p.m. to 7 a.m. period, when episodes of low blood sugar called hypoglycemia can be particularly dangerous. The study presented today at the American Diabetes Association’s annual meeting in Chicago found patients’ blood sugar was in the recommended range for more than 90 percent of the night.
The results are another step toward automating insulin delivery for diabetic patients who don’t naturally produce enough of the hormone to convert their blood sugar to energy. Typically, patients must test their blood repeatedly during the day with finger sticks or a glucose monitor, then inject themselves with the hormone using a needle or an insulin pump.
“Avoiding hypoglycemia during the overnight period is a primary concern for people with diabetes,” said Ramakrishna Venugopalan, director of research and development at J&J’s division that’s developing the device, called Animas. “Maintaining safe glucose levels during this time frame is crucial in helping to not only achieve better control, but also helps ease worry throughout the night.”
The system from J&J’s Animas division uses a computer algorithm and readings from a continuous glucose monitor to calculate the amount of insulin a patient will need to ensure their blood sugar remains in a safe range. Fewer than half the volunteers had their levels drop into dangerous territory, when complications including seizures, loss of consciousness and death can occur. No unexpected safety issues arose.
“We are feeling very confident with the data we have gotten so far in understanding the capabilities of the algorithm, the risks associated with it and the features we want,” said Venugopalan, in a telephone interview.
The study was conducted during a closely monitored overnight visit using machines built for the clinical trial process. Animas has received approval to conduct a third feasibility study of its approach to look for any flaws before it begins trials that will allow patients to live at home for weeks or months with the automated system, Venugopalan said.
About 5 percent of the 25.8 million Americans with diabetes have the Type 1 form, where the body doesn’t produce insulin. The condition is typically diagnosed in children and young adults. Patients rely on regular injections of insulin, which is used to covert blood sugar into energy.