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
- Artificial Pancreas - Medical Devices Pipeline Assessment, 2019 on November 13, 2019 at 4:36 pm
New York, Nov. 13, 2019 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Artificial Pancreas - Medical Devices Pipeline Assessment, 2019" - ...
- 'Artificial Pancreas' One Step Closer to Reality on November 13, 2019 at 5:33 am
‘If we can detect the size of a meal, we can offer suggestions about how much insulin is needed in response.’ "This brings us a step closer to the holy grail -- an 'artificial pancreas' that can ...
- Artificial Pancreas Market Upcoming Key Events & Latest Innovations in the Industry By 2026 on November 12, 2019 at 10:56 pm
Nov 13, 2019 (Global QYResearch via COMTEX) -- Artificial Pancreas Market 2019: This report provides a basic overview of the industry, including its definition, applications and manufacturing ...
- Automated meal detection system brings 'artificial pancreas' one step closer to reality on November 12, 2019 at 8:51 am
"This brings us a step closer to the holy grail -- an 'artificial pancreas' that can quickly detect glucose changes, and correct them with an insulin pump, without the user having to do anything," ...
- Artificial Pancreas Device System Market Share Detailed Analysis of Current Industry Figures with Forecasts Growth By 2028 on November 12, 2019 at 4:38 am
region, the number of persons employed increased from 1 million in 2008 to 1.4 million in 2017. Additionally, the expenditure on private health insurance is anticipated to achieve 5.1% growth every ...
- Artificial Pancreas Device System (APDS) Market 2019 Strategic Assessment – Medtronic, Bigfoot Biomedical, Beta Bionics, Admetsys on November 10, 2019 at 11:26 pm
Nov 11, 2019 (Market Insight Reports via COMTEX) -- "Global ??Artificial Pancreas Device System (APDS) Market Research Report 2019-2025" helps the clients to take business decisions and to understand ...
- Israeli artificial pancreas may one day cure diabetes on November 10, 2019 at 10:46 pm
Ahead of International Diabetes Day, November 14, Israeli startup Betalin Therapeutics announced that it is beginning the application process for clinical trials of its revolutionary artificial ...
- New app to improve experience of closed-loop artificial pancreas on November 7, 2019 at 7:24 am
A new app is being developed which aims to improve the user experience of a closed-loop artificial pancreas for people of different ages and capabilities. The app project, funded by type 1 diabetes ...
- Artificial Pancreas Device System Market Share Value, Top Manufacturers, Application, Size Growth, Cost Structure Analysis and Global Industry Trends on November 5, 2019 at 12:21 am
Artificial Pancreas Device System Market Share, Application and Cost Structure Analysis By Type (Control to Range (CTR) and Control to Target (CTT) Systems), Key Players, Region and Segmentation, ...
- Global artificial pancreas device system market is expected to grow with a CAGR of 15.5% over the forecast period from 2019-2025 on October 29, 2019 at 5:34 am
New York, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Artificial Pancreas Device System Market: Global Industry Analysis ...
via Bing News