MSGID: 1:317/3 6413ecf3   
   PID: hpt/lnx 1.9.0-cur 2019-01-08   
   TID: hpt/lnx 1.9.0-cur 2019-01-08   
    Artificial pancreas improves blood sugar control for kids ages 2-6,   
   study finds    
    Participants spent 3 more hours per day in target blood sugar range    
      
     Date:   
         March 16, 2023   
     Source:   
         University of Virginia Health System   
     Summary:   
         An artificial pancreas improves blood sugar control in children   
         ages 2 to 6 with type 1 diabetes, according to a new study.   
      
      
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   FULL STORY   
   ==========================================================================   
   An artificial pancreas originally developed at the University of Virginia   
   Center for Diabetes Technology improves blood sugar control in children   
   ages 2 to 6 with type 1 diabetes, according to a new study. Details   
   of the clinical study and its findings were just published in the New   
   England Journal of Medicine.   
      
      
   ==========================================================================   
   Trial participants using the artificial pancreas spent approximately   
   three more hours per day in their target blood sugar range compared with   
   participants in a control group who continued relying on the methods   
   they were already using to manage their blood sugar.   
      
   The Control-IQ system, manufactured by Tandem Diabetes Care, is a   
   diabetes management device thatautomatically monitors and regulates blood   
   glucose. The artificial pancreas has an insulin pump that uses advanced   
   control algorithms based on the person's glucose-monitoring information   
   to adjust the insulin dose as needed.   
      
   Based on findings from two earlier studies, the system has previously   
   been approved by the U.S. Food and Drug Administration for people ages   
   6 and older with type 1 diabetes.   
      
   "After the resounding success of Control-IQ technology in people ages   
   6 and up, it is very rewarding to see our youngest patients, and often   
   the most challenging patients to help, benefit as well," said Marc   
   D. Breton, PhD, a UVA School of Medicine researcher who served as the   
   trial's principal investigator and was recently honored as UVA's 2022   
   Innovator of the Year. "With these results, we have now accumulated   
   years of clinical validation of this system across all age groups and   
   look forward to seeing this life-changing technology made available   
   to the broadest possible population."  Used During Everyday Life The   
   study enrolled 102 children between ages 2 and 6 at three U.S. sites   
   (UVA, Stanford University and the University of Colorado) and randomly   
   assigned 68 of them to use the artificial pancreas system for 13 weeks,   
   while the remaining 34 children were assigned to the control group. All   
   participants maintained their regular daily routines during the study.   
      
   On average, the time participants using the artificial pancreas spent   
   within their target blood glucose range was about 12 percentage points   
   higher than participants in the control group overall and 18 percentage   
   points higher during the overnight hours of 10 p.m. to 6 a.m. Nighttime   
   blood glucose control is particularly important, as severe, unchecked   
   hypoglycemia (very low blood glucose levels) can lead to seizures,   
   coma or even death.   
      
   Overall, the researchers found, participants were able to use the   
   artificial pancreas safely. There were two cases of severe hypoglycemia   
   in the artificial pancreas group, compared with one in the control   
   group. There was also one case of diabetic ketoacidosis in the artificial   
   pancreas group, caused by a failure of the thin plastic tube that connects   
   the insulin pump to the patient's body.   
      
   Of note, most of the study-related visits -- including 80% of the training   
   sessions on the artificial pancreas and more than 90% of the overall   
   visits - - were conducted virtually. Achieving the reported results   
   under these conditions highlights the ease of use of the technology and   
   its potential for areas without easy access to endocrinologists.   
      
   "At the end of the day, this technology significantly improved glycemia   
   and ensured safety of our youngest patients, but perhaps just as   
   importantly it lessened these families' constant anxiety about glucose   
   levels, especially during the night." Breton said. "It is incredibly   
   rewarding for us to hear about these families' experiences and how they   
   manage to integrate these new tools in their life, offering some reprieve   
   to the challenges they face."  Findings Published The study results have   
   been published in the New England Journal of Medicine.   
      
   The study's authors are R. Paul Wadwa, Zachariah W. Reed, Bruce   
   A. Buckingham, Mark D. DeBoer, Laya Ekhlaspour, Gregory P. Forlenza,   
   Melissa Schoelwer, John Lum, Craig Kollman, Roy W. Beck and Breton.   
      
   This study was funded by the National Institutes of Health's   
   National Institute of Diabetes and Digestive and Kidney Diseases,   
   grant U01DK127551. Tandem Diabetes Care provided the investigational   
   closed-loop systems used in the trial, while Dexcom, Inc. provided the   
   continuous glucose monitor supplies used in the trial.   
      
       * RELATED_TOPICS   
             o Health_&_Medicine   
                   # Diabetes # Hormone_Disorders # Hypertension #   
                   Healthy_Aging # Blood_Clots # Medical_Topics #   
                   Diseases_and_Conditions # Diet_and_Weight_Loss   
       * RELATED_TERMS   
             o Diabetes o Diabetes_mellitus_type_1 o Hyperglycemia o   
             Diabetes_mellitus_type_2 o Insulin o Sugar_substitute o   
             Diabetic_diet o Blood_sugar   
      
   ==========================================================================   
   Story Source: Materials provided by   
   University_of_Virginia_Health_System. Note: Content may be edited for   
   style and length.   
      
      
   ==========================================================================   
   Journal Reference:   
      1. R. Paul Wadwa, Zachariah W. Reed, Bruce A. Buckingham, Mark   
      D. DeBoer,   
         Laya Ekhlaspour, Gregory P. Forlenza, Melissa Schoelwer,   
         John Lum, Craig Kollman, Roy W. Beck, Marc D. Breton. Trial   
         of Hybrid Closed-Loop Control in Young Children with Type   
         1 Diabetes. New England Journal of Medicine, 2023; 388 (11):   
         991 DOI: 10.1056/NEJMoa2210834   
   ==========================================================================   
      
   Link to news story:   
   https://www.sciencedaily.com/releases/2023/03/230316140931.htm   
      
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