A New Approach For Controlling Type 1 Diabetes In Children
Release date：2020/9/4 7:49:58
Type 1 diabete, is a chronic disease in which the pancreas produces little or no insulin. Type 1 diabetes in children is a condition in which children's body no longer produces an important hormone (insulin). The children need insulin to survive, so the missing insulin needs to be replaced with injections or with an insulin pump. Type 1 diabetes in children used to be known as juvenile diabetes or insulin-dependent diabetes. Type 1 diabetes occurs when the body's own immune system destroys insulin-producing beta cells in pancreas.
Recently, a clinical trial at four pediatric diabetes centers in USA has found that a new artificial pancreas system -- which automatically monitors and regulates blood glucose levels -- is safe and effective at managing blood glucose levels in children as young as age six with type 1 diabetes. The trial was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health. Results from the trial were published on August 26 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 uses a continuous glucose monitor (CGM) to track blood glucose levels and uses an insulin pump to automatically deliver insulin when needed . The system replaces the reliance on testing by fingerstick or CGM with delivery of insulin by multiple daily injections or a pump controlled by the patient or caregiver.
The study recruited 101 children between ages 6 and 13 and divided them into the experimental group and control groups. The experimental group used the new artificial pancreas system, and the control group used a standard CGM and separate insulin pump. Over a period of four months, inspections and data collection were conducted every other week.
After four months, results come out. The study showed that youth who using the artificial pancreas system had 7% improvement in keeping blood glucose in range during the daytime, and had a 26% improvement in nighttime control compared to the control group. Nighttime control is especially important for people with type 1 diabetes, as severe, uncontrolled hypoglycemia can lead to seizure, coma or even death. The overall time-in-range goal for the artificial pancreas reflected a nearly 11% improvement, which translated to 2.6 more hours per day in range.
The artificial pancreas technology used in this study is the Control-IQ system, has an insulin pump that is programmed with an advanced control algorithm based on a mathematical model using the person's glucose monitoring information to adjust the insulin dose automatically. This technology was based on a system originally developed at the University of Virginia (UVA), in Charlottesville, which was funded by NIDDK.
The four-month study was part of a series of trials conducted in the International Diabetes Closed-Loop (iDCL) Study. Based on the data from the iDCL trials, Tandem Diabetes Care has obtained approval from the U.S. Food and Drug Administration to use the Control-IQ system for 6-year-old children.
The iDCL Study is one of the four major research projectss funded by NIDDK through the Special Statutory Funding Program for Type 1 Diabetes to detect and refine advanced artificial pancreas systems. These studies, with additional results forthcoming, also conside many factors including safety, efficacy, user-friendliness, physical and emotional health of participants, and cost.
This study was funded by NIDDK and Tandem Diabetes, Inc. Tandem provided the experimental closed-loop systems used in the trial, system-related supplies including the Dexcom CGM and Roche glucometer, and technical expertise.
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Marc D. Breton, Lauren G. Kanapka, Roy W. Beck, Laya Ekhlaspour, Gregory P. Forlenza, Eda Cengiz, Melissa Schoelwer, Katrina J. Ruedy, Emily Jost, Lori Carria, Emma Emory, Liana J. Hsu, Mary Oliveri, Craig C. Kollman, Betsy B. Dokken, Stuart A. Weinzimer, Mark D. DeBoer, Bruce A. Buckingham, Daniel Cherñavvsky, R. Paul Wadwa. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. New England Journal of Medicine, 2020; 383 (9): 836 DOI: 10.1056/NEJMoa2004736