| A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children Aged 4 to <10 Years. | |
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MedLine Citation:
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PMID: 22210571 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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OBJECTIVEContinuous glucose monitoring (CGM) has been demonstrated to improve glycemic control in adults with type 1 diabetes but less so in children. We designed a study to assess CGM benefit in young children aged 4 to 9 years with type 1 diabetes.RESEARCH DESIGN AND METHODSAfter a run-in phase, 146 children with type 1 diabetes (mean age 7.5 ± 1.7 years, 64% on pumps, median diabetes duration 3.5 years) were randomly assigned to CGM or to usual care. The primary outcome was reduction in HbA(1c) at 26 weeks by ≥0.5% without the occurrence of severe hypoglycemia.RESULTSThe primary outcome was achieved by 19% in the CGM group and 28% in the control group (P = 0.17). Mean change in HbA(1c) was -0.1% in each group (P = 0.79). Severe hypoglycemia rates were similarly low in both groups. CGM wear decreased over time, with only 41% averaging at least 6 days/week at 26 weeks. There was no correlation between CGM use and change in HbA(1c) (r(s) = -0.09, P = 0.44). CGM wear was well tolerated, and parental satisfaction with CGM was high. However, parental fear of hypoglycemia was not reduced.CONCLUSIONSCGM in 4- to 9-year-olds did not improve glycemic control despite a high degree of parental satisfaction with CGM. We postulate that this finding may be related in part to limited use of the CGM glucose data in day-to-day management and to an unremitting fear of hypoglycemia. Overcoming the barriers that prevent integration of these critical glucose data into day-to-day management remains a challenge. |
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Authors:
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Nelly Mauras; Roy Beck; Dongyuan Xing; Katrina Ruedy; Bruce Buckingham; Michael Tansey; Neil H White; Stuart A Weinzimer; William Tamborlane; Craig Kollman; |
Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-12-30 |
Journal Detail:
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Title: Diabetes care Volume: - ISSN: 1935-5548 ISO Abbreviation: - Publication Date: 2011 Dec |
Date Detail:
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Created Date: 2012-1-2 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7805975 Medline TA: Diabetes Care Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Division of Pediatric Endocrinology, Nemours Children's Clinic, Jacksonville, Florida. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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