In patients with Type 1 diabetes, the pancreas is no longer capable of producing insulin. According to the American Diabetes Association, living with the condition is particularly challenging as patients are subject to multiple, daily injections of insulin through pens, syringes or pumps to stay alive. Close monitoring of blood sugar levels and timely administration of insulin are key. About 5% of people with diabetes have this form of the disease.
Biomedical engineer Edward Damiano of Boston University, whose son has Type 1 diabetes, created a device to help his son manage the complexities of living with the condition. In the new NEJM report, Damiano and colleagues evaluated the use of this bionic, or artificial, pancreas which was made by connecting an iPhone 4S to a DexCom G4 glucose monitor.
Researchers followed 20 adults (in one study) and 32 adolescents (in a separate study) who had Type 1 diabetes and had been receiving insulin-pump therapy. The participants were first monitored while going about their normal routine, although the G4 monitor was attached to get a baseline of their levels during this control period. When the full bionic pancreas was attached, which includes a sensor placed under the skin, patients were asked to eat what they wanted over a five-day period. The sensor provided information about their glucose levels to the app, and insulin and glucagon as needed were administered by the automated device through infusion pumps controlled wirelessly by the iPhone.
Blood sugar was better managed by both adults and children when the bionic pancreas was used, according to the findings. Compared with the insulin pump, which is administered by the patient, the wearable, automated, bionic pancreas improved mean glycemic levels and led to less hypoglycemic episodes. The results are intriguing but preliminary. There were only 52 participants in the trial. The authors also note other limitations, such as a tendency of the device to deliver more insulin to adult patients who had demonstrated poor management during the control phase. Also, the evaluation did not consider use of certain medications, such as acetaminophen, which can lead to an overestimation of blood glucose levels.
The study, presented during the American Diabetes Association's 74th annual scientific session in San Francisco, was conducted by researchers from Massachusetts General Hospital, Harvard Medical School and Boston University. Several potential conflicts of interest were listed in the disclosures. One researcher holds a related patent and has pending patent applications related to blood glucose control. Others had received lecture or consulting fees from device manufacturers, including DexCom and Medtronic, and drugmakers such as Eli Lilly and Co. and Sanofi.
On June 14, Sanofi and Medtronic announced they had joined forces to address diabetes. The companies hope to pair Sanofi's insulin portfolio and drug development work with Medtronic's knowledge of insulin pumps and continuous glucose monitoring. The alliance would initially focus on the development of drug-device combinations and delivery of care-management services to improve adherence, simplify insulin treatment, and help people with diabetes better manage their condition.
“We believe there is tremendous opportunity to better align care across the diabetes-care continuum through new and varied technologies and patient care-management strategies,” the release said.
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