Journal article
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
Diabetes care, Vol.35(2), pp.204-210
2012
DOI: 10.2337/dc11-1746
PMCID: PMC3263860
PMID: 22210571
Abstract
OBJECTIVE Continuous 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 METHODS After 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 HbA1c at 26 weeks by ≥0.5% without the occurrence of severe hypoglycemia.
RESULTS The primary outcome was achieved by 19% in the CGM group and 28% in the control group (P = 0.17). Mean change in HbA1c 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 HbA1c (rs = −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.
CONCLUSIONS CGM 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.
Details
- Title: Subtitle
- 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
- Creators
- Nelly MAURAS - Division of Pediatric Endocrinology, Nemours Children's Clinic, Jacksonville, Florida, United StatesRoy BECK - Jaeb Center for Health Research, Tampa, Florida, United StatesDONGYUAN XING - Jaeb Center for Health Research, Tampa, Florida, United StatesKatrina RUEDY - Jaeb Center for Health Research, Tampa, Florida, United StatesBruce BUCKINGHAM - Division of Pediatric Endocrinology, Stanford University, Stanford, California, United StatesMichael TANSEY - Division of Pediatric Endocrinology, University of Iowa, Iowa City, Iowa, United StatesNeil H WHITE - Department of Pediatrics, Washington University, St. Louis, Missouri, United StatesStuart A WEINZIMER - Division of Pediatric Endocrinology, Yale University, New Haven, Connecticut, United StatesWilliam TAMBORLANE - Division of Pediatric Endocrinology, Yale University, New Haven, Connecticut, United StatesCraig KOLLMAN - Jaeb Center for Health Research, Tampa, Florida, United StatesDiabetes Research in Children Network (DirecNet) Study Group
- Resource Type
- Journal article
- Publication Details
- Diabetes care, Vol.35(2), pp.204-210
- DOI
- 10.2337/dc11-1746
- PMID
- 22210571
- PMCID
- PMC3263860
- NLM abbreviation
- Diabetes Care
- ISSN
- 0149-5992
- eISSN
- 1935-5548
- Publisher
- American Diabetes Association
- Language
- English
- Date published
- 2012
- Academic Unit
- Endocrinology and Diabetes; Stead Family Department of Pediatrics; Fraternal Order of Eagles Diabetes Research Center
- Record Identifier
- 9984093495402771
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