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
- Nelly Mauras, MD1⇓,
- Roy Beck, MD, PHD2,
- Dongyuan Xing, MPH2,
- Katrina Ruedy, MSPH2,
- Bruce Buckingham, MD3,
- Michael Tansey, MD4,
- Neil H. White, MD5,
- Stuart A. Weinzimer, MD6,
- William Tamborlane, MD6,
- Craig Kollman, PHD2 and
- the Diabetes Research in Children Network (DirecNet) Study Group*
- 1Division of Pediatric Endocrinology, Nemours Children’s Clinic, Jacksonville, Florida
- 2Jaeb Center for Health Research, Tampa, Florida
- 3Division of Pediatric Endocrinology, Stanford University, Stanford, California
- 4Division of Pediatric Endocrinology, University of Iowa, Iowa City, Iowa
- 5Department of Pediatrics, Washington University, St. Louis, Missouri
- 6Division of Pediatric Endocrinology, Yale University, New Haven, Connecticut
- Corresponding author: Nelly Mauras, .
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.
- Received September 8, 2011.
- Accepted October 30, 2011.
- © 2012 by the American Diabetes Association.
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