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      Predictive Low-Glucose Insulin Suspension Reduces Duration of Nocturnal Hypoglycemia in Children Without Increasing Ketosis

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          Abstract

          OBJECTIVE

          Nocturnal hypoglycemia can cause seizures and is a major impediment to tight glycemic control, especially in young children with type 1 diabetes. We conducted an in-home randomized trial to assess the efficacy and safety of a continuous glucose monitor–based overnight predictive low-glucose suspend (PLGS) system.

          RESEARCH DESIGN AND METHODS

          In two age-groups of children with type 1 diabetes (11–14 and 4–10 years of age), a 42-night trial for each child was conducted wherein each night was assigned randomly to either having the PLGS system active (intervention night) or inactive (control night). The primary outcome was percent time <70 mg/dL overnight.

          RESULTS

          Median time at <70 mg/dL was reduced by 54% from 10.1% on control nights to 4.6% on intervention nights ( P < 0.001) in 11–14-year-olds ( n = 45) and by 50% from 6.2% to 3.1% ( P < 0.001) in 4–10-year-olds ( n = 36). Mean overnight glucose was lower on control versus intervention nights in both age-groups (144 ± 18 vs. 152 ± 19 mg/dL [ P < 0.001] and 153 ± 14 vs. 160 ± 16 mg/dL [ P = 0.004], respectively). Mean morning blood glucose was 159 ± 29 vs. 176 ± 28 mg/dL ( P < 0.001) in the 11–14-year-olds and 154 ± 25 vs. 158 ± 22 mg/dL ( P = 0.11) in the 4–10-year-olds, respectively. No differences were found between intervention and control in either age-group in morning blood ketosis.

          CONCLUSIONS

          In 4–14-year-olds, use of a nocturnal PLGS system can substantially reduce overnight hypoglycemia without an increase in morning ketosis, although overnight mean glucose is slightly higher.

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          Most cited references 27

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          Outpatient glycemic control with a bionic pancreas in type 1 diabetes.

          The safety and effectiveness of automated glycemic management have not been tested in multiday studies under unrestricted outpatient conditions.
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            Nocturnal glucose control with an artificial pancreas at a diabetes camp.

            Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.
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              Epidemiology of severe hypoglycemia in the diabetes control and complications trial. The DCCT Research Group.

              (1991)
              The present study describes the epidemiology of severe hypoglycemia and identifies patient characteristics or behaviors associated with severe hypoglycemia in patients with insulin-dependent diabetes mellitus (IDDM) participating in the Diabetes Control and Complications Trial (DCCT). The DCCT is a multicenter randomized clinical trial designed to compare the benefits and risks of intensive therapy with those of conventional management of IDDM. The DCCT's feasibility phase demonstrated that intensive therapy, with the aim of achieving glucose levels as close to the non-diabetic range as possible, was accompanied by a threefold increase in severe hypoglycemia compared with conventional therapy. This report is based on the first 817 subjects who entered the DCCT, with a mean follow-up of 21 months. Two hundred sixteen subjects reported 714 episodes of severe hypoglycemia; 549 (77%) occurred in intensively treated subjects. The incidence of severe hypoglycemia in the intensive treatment group ranged from two to six times that observed with conventional treatment. Severe hypoglycemia occurred more often during sleep (55%); 43% of all episodes occurred between midnight and 8 AM. Of episodes that occurred while subjects were awake, 36% were not accompanied by warning symptoms. In intensively treated subjects, predictors of severe hypoglycemia included history of severe hypoglycemia, longer duration of IDDM, higher baseline glycosylated hemoglobin (HbA1c) levels, and a lower recent HbA1c. Multivariate analyses failed to yield predictive models with high sensitivity. In the DCCT, intensive treatment of IDDM increased the frequency of severe hypoglycemia relative to conventional therapy. Intensive treatment may cause even more frequent severe hypoglycemia when applied to less selected and less motivated populations in the clinical practice setting. These findings underscore the importance of determining the benefit-risk ratio of intensive and standard therapy of IDDM.
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                Author and article information

                Journal
                Diabetes Care
                Diabetes Care
                diacare
                dcare
                Diabetes Care
                Diabetes Care
                American Diabetes Association
                0149-5992
                1935-5548
                July 2015
                11 June 2015
                : 38
                : 7
                : 1197-1204
                Affiliations
                1Stanford University, Stanford, CA
                2Jaeb Center for Health Research, Tampa, FL
                3Rensselaer Polytechnic Institute, Troy, NY
                4Barbara Davis Center for Childhood Diabetes, Aurora, CO
                5St. Joseph’s Health Care, London, ON, Canada
                6Children’s Hospital, London Health Sciences Centre, London, ON, Canada
                Author notes
                Corresponding author: Roy W. Beck, rbeck@ 123456jaeb.org .
                Article
                3053
                10.2337/dc14-3053
                4477332
                26049549
                © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.
                Page count
                Pages: 8
                Product
                Funding
                Funded by: National Institute of Diabetes and Digestive and Kidney Diseases
                Award ID: R01DK085591
                Funded by: Juvenile Diabetes Research Foundation International http://dx.doi.org/10.13039/100000901
                Award ID: 22-2013-266
                Award ID: 80-2010-585
                Categories
                Diabetes Care Symposium

                Endocrinology & Diabetes

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