Extended 6-Month Follow-Up of 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
Author(s) -
Michael Tansey,
Stuart A. Weinzimer,
Roy W. Beck,
Katrina J. Ruedy,
Peiyao Cheng,
William V. Tamborlane,
Craig Kollman,
Nelly Mauras,
Larry A. Fox,
Julie Coffey,
Neil H. White
Publication year - 2013
Publication title -
diabetes care
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.636
H-Index - 363
eISSN - 1935-5548
pISSN - 0149-5992
DOI - 10.2337/dc12-2021
Subject(s) - medicine , randomized controlled trial , continuous glucose monitoring , diabetes mellitus , type 1 diabetes , clinical trial , blood glucose self monitoring , type 2 diabetes , patient satisfaction , pediatrics , physical therapy , surgery , endocrinology
In a 6-month randomized trial of continuous glucose monitoring (CGM) in children 4–9 years of age with type 1 diabetes (1), the DirecNet Study Group reported no difference in change in A1C between the CGM and usual care groups, although parents expressed high satisfaction with use of CGM. In a 6-month posttrial phase, the CGM group continued to use CGM and the control group was started on CGM. This observation provides a summary of the findings for both groups during this posttrial phase.Sixty-four of the 69 children in the CGM group who completed the trial participated in the extension phase; all 64 completed the 12-month visit. Baseline A1C was 7.9 ± 0.8 and 7.8 ± 0.8% at the beginning of the extension phase and 7.9 ± 0.8% at 12 months. During the extension phase, A1C decreased ≥0.5% in 14% and increased ≥0.5% in 25%. Sensor use dropped from a median of 92 h/week at 6 months to …
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