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The artificial pancreas -- a device which monitors blood glucose in patients with type 1 diabetes and then automatically adjusts levels of insulin entering the body -- is likely to be available by 2018, conclude authors of a paper in Diabetologia (the journal of the European Association for the Study of Diabetes). Issues such as speed of action of the forms of insulin used, reliability, convenience and accuracy of glucose monitors plus cybersecurity to protect devices from hacking, are among the issues that are being addressed.
1.5 million people in the United States have Type 1 diabetes. The amount of insulin they need at any given moment is always changing — day to day, hour to hour, even minute to minute. Insulin is the hormone that allows your body’s cells to absorb glucose, the gasoline that makes cells go. No insulin, no life.
Three of these academic competitors — Hovorka, Kovatchev and Phillip — have already partnered with companies to commercialize their efforts. Hovorka and Phillip are with Medtronic, the current industry leader in diabetes technology; Kovatchev is with a startup named TypeZero Technologies.
Another competitor Damiano founded a “public benefit” corporation in October, the kind normally used to run transit systems and utilities. The firm, Beta Bionics, quickly secured $5 million in funding from Eli Lilly and Co., the pharmaceutical giant. Damiano serves as CEO but remains a professor at Boston University, where he continues to seek research grants from NIH.
“Diabetes management, especially with children, is a challenge,” Michael Alan Wood, MD, associate professor of pediatrics and clinical director of the pediatric diabetes program at the University of Michigan Medical School in Ann Arbor, said during a press conference at the Endocrine Society Annual Meeting. “The MiniMed 670G system may provide means to address and improve glycemic control in some patients living with type 1 diabetes.” The MiniMed 670G system (Medtronic), the first hybrid closed-loop system for type 1 diabetes, was approved by the FDA in October 2016 and launched in the United States in June 2017. The system features Medtronic’s SmartGuard HCL technology and Guardian Sensor 3, the only FDA-approved insulin pump that enables personalized and automated delivery of basal insulin. Blood glucose is also monitored using the Contour Next Link 2.4 blood glucose monitoring system (Ascensia Diabetes Care). The MiniMed system is not FDA approved for children aged 14 years or younger.
In a single-arm study, Wood and colleagues analyzed data from 105 children aged 7 to 13 years with type 1 diabetes (mean age, 11 years; 49 girls; mean BMI, 19.1 kg/m²; mean diabetes duration, 5.6 years; mean baseline HbA1c, 7.9%). All participants were using insulin pump therapy for at least 5 months at eight U.S. sites and one site in Israel. Following an in-clinic evaluation, children used the MiniMed system in open-loop, manual mode for 2 weeks, followed by closed-loop, automatic mode for 3 months. Study endpoints were change in HbA1c from baseline to 3 months and reports of severe hypoglycemia and DKA. Additionally, researchers compared data for the cohort with data from similar trials involving 30 adolescents aged 14 to 21 years and 94 adults aged 22 to 75 years. From baseline to 3 months, HbA1c improved from a mean of 7.9% to 7.5%, Wood said, as did overall variability of sensor glucose values. Total daily dose of insulin increased slightly, from a mean of 0.8 units per day to 0.9 units per day.
Wood noted the researchers were most excited by the marked improvement in time spent in the target blood glucose range of 71 mg/dL to 180 mg/dL, which increased from 56% to 65% in the pediatric group over 3 months of use. The results were comparable to those observed in the adolescent and adult groups, in whom time-in-range improved from 60% to 67% and 68% to 78.3%, respectively, over 3 months of artificial pancreas use. No adverse events were reported, Wood said. “Of the more than 12,000 patient days of system use by the adolescent and adult groups, and the more than 15,000 patient days of patient use by the 7-to-13-year-olds, there were no severe hypoglycemic events and no diabetic ketoacidosis events, which is, really, an exceptional safety record,” Wood said. “The data showed that, compared to baseline, 3-month use of this system in all three age groups improved the average glucose value, reduced day and night variability, improved time-in-target range and reduced hypoglycemia.” All except three children continued to use the system after the study via the Continued Access Program, Wood said.
Artificial pancreas safe, effective in young children with type 1 diabetes
