study of people with type 1
diabetes shows safety, efficacy benefits of new system.
18th October. A multicenter randomized clinical trial evaluating a
new artificial pancreas system — which automatically monitors and regulates
blood glucose levels — has found that the new system was more effective than
existing treatments at controlling blood glucose levels in people with type 1 diabetes. The trial was primarily funded by the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the
National Institutes of Health affiliated to U.S. Department of
Health and Human Services.
but serious challenge for children
showed that the system improved participants’ blood glucose control throughout
the day and overnight. The latter is a common but serious challenge for
children and adults with type 1 diabetes,
since blood glucose can drop to dangerously low levels when a person is asleep.
The research is published in the New England Journal of Medicine.
a press release of NIH, The artificial pancreas, also known as
closed-loop control, is an “all-in-one” diabetes management system
that tracks blood glucose levels using a continuous glucose monitor
(CGM) and automatically delivers the hormone insulin when needed using an
insulin pump. The system replaces reliance on testing by fingerstick or CGM
with separate delivery of insulin by multiple daily injections or a pump.
International Diabetes Closed-Loop (iDCL) Study involves five separate
artificial pancreas clinical protocols implemented by 10 research centers in the United States and Europe. This
six-month study was the third phase in a series of trials. It was conducted
with participants living their usual day-to-day lives, so the researchers could
best understand how the system works in typical daily routines.
“Testing the safety and effectiveness
of new technologies in real-world settings is critical to prove the usability
of these systems by people with diabetes to achieve a better daily control of
their blood glucose levels,” said Guillermo Arreaza-Rubín, M.D., director of
NIDDK’s Diabetes Technology Program and project scientist for the study.
“Earlier technologies have made the management of type 1 diabetes easier, and this research shows that this
artificial pancreas system has the potential to improve the health of people
living with type 1 diabetes, while also potentially
lifting much of the burden of care from those with the disease and their
protocol enrolled 168 participants age 14 or older with type 1 diabetes.
They were randomly assigned to use either the artificial pancreas system called
Control-IQ or sensor-augmented pump (SAP) therapy with a CGM and insulin pump
that did not automatically adjust insulin throughout the day. Participants had
contact with study staff every two to four weeks to download and review device
data. No remote monitoring of the systems was done, so that the study would
reflect real-world use.
researchers found that users of the artificial pancreas system significantly
increased the amount of time with their blood glucose levels in the target
range of 70 to 180 mg/dL by an average of 2.6 hours per day since beginning the trial, while the time in
range in the SAP group remained unchanged over six months. Artificial pancreas
users also showed improvements in time spent with high and low blood glucose,
hemoglobin A1c, and other measurements related to
diabetes control compared to the SAP group. High adherence to device use in
both groups and 100% participant retention were important
strengths of the study. During the study, no severe hypoglycemia events
occurred in either group. Diabetic ketoacidosis occurred in one participant in
the artificial pancreas group due to a problem with equipment that delivers
insulin from the pump.
Control-IQ technology was derived from a system originally developed at the
University of Virginia, Charlottesville, (UVA) by a team led by Boris
Kovatchev, Ph.D., director of the UVA Center for Diabetes Technology with
funding support from NIDDK. In this system, the insulin pump is programmed with
advanced control algorithms based on a mathematical model that uses the
person’s glucose monitoring information to automatically adjust the insulin
dose. Tandem Diabetes Care has submitted the results to the U.S. Food and Drug
Administration for approval to market the Control-IQ system.
“This artificial pancreas system has several unique features that improve glucose control beyond what is achievable using traditional methods,” said Kovatchev. “In particular, there is a special safety module dedicated to prevention of hypoglycemia, and there is gradually intensified control overnight to achieve near-normal blood sugar levels every morning.”
was co-lead author of the study with colleagues Sue A. Brown, M.D., of UVA and
Roy Beck, M.D., Ph.D., from the Jaeb Center for Health Research, Tampa,
Florida, which was the coordinating center for the study.
“Artificial pancreas technology has
tremendous potential to improve the day-to-day lives of people with type 1 diabetes,” said NIDDK Director Griffin P. Rodgers, M.D. “By
making management of type 1 diabetes
easier and more precise, this technology could reduce the daily burden of this
disease, while also potentially reducing diabetes complications including eye,
nerve, and kidney diseases.”
The iDCL Study is one of four major research efforts funded by NIDDK through the Special Statutory Funding Program for Type 1 Diabetes to test and refine advanced artificial pancreas systems. The studies, with additional results forthcoming, are looking at factors including safety, efficacy, user-friendliness, physical and emotional health of participants, and cost.
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