NIH-funded study of people with type 1 diabetes shows safety, efficacy benefits of new system
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.
The study 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 sugar can drop to dangerously low levels when a person is asleep. The research is published in the New England Journal of Medicine.
The artificial pancreas, also known as closed-loop control, is an “all-in-one” diabetes management system that tracks blood-sugar 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.
The 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 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 caregivers.”
This iDCL 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.
The 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.
The 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.”
Kovatchev 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 Latest on: Artificial pancreas
via Google News
The Latest on: Artificial pancreas
- High school student develops artificial pancreason May 15, 2022 at 2:00 am
A student from Assumption High School is participating in the Canada-Wide Science Fair this week after developing an artificial pancreas. Sohila Sidhu developed the prototype as part of her Grade 10 ...
- Windsor high school student's 'artificial pancreas' prototype lands accoladeson May 13, 2022 at 1:21 pm
A Windsor high school student is heading to a national science fair competition after winning local accolades for her “artificial pancreas” prototype, which could make diabetes easier to manage.
- Innovative Drug Delivery Company Partners with Fortune 100 Global Foundry for Next-Generation Artificial Pancreason May 11, 2022 at 8:54 pm
AiTA is developing an integrated Micro-Electro-Mechanical Systems (MEMS) augmented biology platform in partnership with a leading Fortune 100 Global MEMS Foundry. Founder of Hammerstone Capital, ...
- Innovative Drug Delivery Company Partners with Fortune 100 Global Foundry for Next-Generation Artificial Pancreason May 11, 2022 at 8:42 pm
NEW YORK, May 11, 2022 /PRNewswire/ -- AiTA Bio, a New York-based bio-MEMS company, today announced it has secured $8.5 million in Series A funding led by Hammerstone Capital, BlackPoint Partners ...
- Artificial Pancreas (AP) Market by Technology Innovation and Growth 2022on May 8, 2022 at 10:55 pm
This report studies the Artificial Pancreas (AP) Market with many aspects of the industry like the market size, market status, market trends and forecast, the report also provides brief ...
- Fully Integrated Artificial Pancreas in Type 1 Diabeteson May 6, 2022 at 5:00 pm
Integrated closed-loop control (CLC), combining continuous glucose monitoring (CGM) with insulin pump (continuous subcutaneous insulin infusion [CSII]), known as artificial pancreas, can help ...
- Artificial Pancreas, Injection Sites, and Fast-Acting Insulin: Diabetes Trends and Challengeson May 3, 2022 at 5:00 pm
Many of the presentations centered around closed-loop monitoring of insulin patients, up to and including the creation of an artificial pancreas. Fundamental elements of closed loop systems are the ...
- North America and Europe Artificial Pancreas Systems Market to reach more than US$ 250 Million by 2026on April 20, 2022 at 8:29 pm
Growing number of diabetics in the US, Canada and European countries has been compelling hospitals to keep artificial pancreas systems in stock. Government-funded organisations in North America and ...
via Bing News