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.
This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc11-1746/-/DC1.
↵*A complete list of members of the DirecNet Study Group can be found in the Appendix.
The contents of this article are solely the responsibility of the authors and do not necessarily represent the official view of the National Center for Research Resources or the National Institutes of Health.
- Received September 8, 2011.
- Accepted October 30, 2011.
- © 2012 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. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.