NIH Announces Major Artificial Pancreas Clinical Trials
The studies will assess the safety, efficacy, and user-friendliness among other aspects, of multiple artificial pancreas devices.
Four major research studies will soon be under way to test and refine the newly developed artificial pancreas system, thanks to nearly $41 million in grant funding, according to a press release from the National Institutes of Health (NIH).
The artificial pancreas, a closed-loop system intended to replace fingerstick testing and continuous glucose monitoring systems in patients with type 1 diabetes, has not yet received regulatory approval. According to the press release, the studies are "designed to be the potential last steps between testing the fully automated devices and requesting regulatory approval for permanent use." The studies will be funded by the National Institute of Diabetes and Digestive and Kidney Diseases.
A hybrid artificial pancreas model requiring manual adjustment at mealtimes was approved in 2016 by the US Food and Drug Administration. The fully automated system would sense rising glucose levels, including at mealtimes, and adjust insulin accordingly.
"Managing type 1 diabetes currently requires a constant juggling act between checking blood glucose levels frequently and delivering just the right amount of insulin while taking into account...aspects of daily life, where a missed or wrong delivery could lead to potential complications," said Andrew A. Bremer, MD, PhD, program director of the Division of Diabetes, Endocrinology, and Metabolic Diseases at the National Institute of Diabetes and Digestive and Kidney Diseases. "Unifying the management of type 1 diabetes into a single, integrated system could lift so much of that burden."
The 4 trials will be coordinated through the Jaeb Center for Health Research in Tampa, Florida. Studies will assess the safety, efficacy, user-friendliness, cost, and physical and emotional health of participants.
- The International Diabetes Closed-Loop Trial will test inControl, an automated insulin delivery system in 240 participants for 6 months. A second 6-month study using a different algorithm will follow (ClinicalTrials.gov identifiers: NCT02985866 and NCT02844517).
- A study at Cambridge University in the United Kingdom will test the use of an artificial pancreas system, incorporating a smartphone component, for 1 year in children and adolescents aged 6 to 18 years (ClinicalTrials.gov identifier: NCT02925299).
- Researchers will compare the hybrid artificial pancreas approved by the US Food and Drug Administration with a next-generation system with a specific focus on glucose control at mealtime in 100 youth participants. Each system will be tested for 3 months (ClinicalTrials.gov identifier: NCT03040414).
- Boston-area investigators will conduct a 6-month study of a bihormonal "bionic pancreas" system in 312 adults. The dual-chamber pump delivers both insulin and glucagon via automated algorithms.
Four pivotal NIH-funded artificial pancreas research efforts begin [news release]. Bethesda, MD: National Institutes of Health; 2017. https://www.nih.gov/news-events/news-releases/four-pivotal-nih-funded-artificial-pancreas-research-efforts-begin. Accessed February 7, 2017.