The National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) www.niddk.nih.gov is funding four separate clinical trials using and conducting tests on the artificial pancreas. The trials are going to study the technology in terms of safety, efficacy, user-friendliness, physical and emotional health of participants, and cost. The Jaeb Center for Health Research in Tampa Florida will serve as the coordinating center.
“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 meals, physical activity, and other aspects of daily life where a missed or wrong delivery could lead to potential complications. Unifying the management of type 1 diabetes into a single integrate system could lift so much of that burden”, said Dr Andrew Bremer, the NIDDK Program Official overseeing the studies.
Previously in shorter studies, the devices tested brought glucose levels closer to normal than traditional management. The four projects beginning in 2017-2018 will be conducted in larger groups over longer periods of time and in largely unrestricted conditions. The participants will live at home and monitor themselves with remote monitoring to be done by study staff.
One of the trials now recruiting titled “International Diabetes Closed-Loop Trial” (DK108483) will be led by Dr. Boris Kovatchev and Dr. Stacey Anderson at the University of Virginia. They are going to test an automated insulin delivery system called inControl.
This trial will use smartphones to follow 240 people age 14 and up with type 1 diabetes for six months. The study will have sites in California, Colorado, Florid, Massachusetts, Minnesota, New York, Virginia, and abroad in France, Holland, and Italy. The funding for the trial is $12,653,694.
A second six month clinical trial will recruit from the participants in the first trial to test an alternative algorithm. Learn more details on both of these trials at Clinicaltrials.gov (NCT02985866) and (NCT02844517).
Early this year, recruitment will begin for youths age 6-18 for a full year clinical trial (NCT02925299). NIH is providing $6,344,942 for the trial (DK108520) to be led by Dr. Roman Hovorka of the University of Cambridge in England.
The trial will enroll 130 youths for a full year that will use an artificial pancreas system with a smartphone as one component. The study will be conducted in California, Colorado, Connecticut, Minnesota, and two sites in the UK.
With NIH grant funding for $6,938.637 (DK108611)) starting in 2017, Dr. Bergenstal of International Diabetes Center in Minneapolis, and Dr. Moshe Phillip of Schneider Children’s Medical Center, and Dr. Petah Tikva from Israel will work together on the clinical trial (NCT03040414).
The trial will compare the FDA-approved hybrid artificial pancreas to a next generation system, programmed to further improve glucose control, particularly around mealtime. One hundred youths will test each system for three months at sites in California, Connecticut, Florida, Massachusetts, Minnesota, and abroad in Germany, Israel, and Slovenia.
Another NIH study (DK108612) with $11,951.319 due to start in mid-2018 led by Dr. Steven Russell of the Massachusetts General Hospital and Dr. Ed Damiano of Boston University are going to enroll 312 people ages 18 and older.
The six month study uses a bihormonal system with a dual-chamber pump to deliver both insulin and the counteracting hormone, glucagon plus use tested algorithms for automated dual-hormone delivery.
The study will take place at two sites in California and one site each in Massachusetts, Michigan, Missouri, North Carolina, Ohio, and Washington. Go to www.bionicpancreas.org for more information.