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, Roy Beck, Dongyuan Xing, Katrina Ruedy, Bruce Buckingham, Michael Tansey, Neil H. White, Stuart A. Weinzimer, William Tamborlane, Craig Kollman, Eva Tsalikian, Michael J. Tansey, Julie Coffey, Joanne Cabbage, Sara Salamati, Larry A. Fox, Kim Englert, Joe Permuy, Kaitlin Sikes, Bruce A. BuckinghamDarrell M. Wilson, Paula Clinton, Kimberly Caswell, William V. Tamborlane, Jennifer Sherr, Amy Steffen, Kate Weyman, Melinda Zgorski, Eileen Tichy, Ana Maria Arbelaez, Lucy Levandoski, Angie Starnes, Roy W. Beck, Katrina J. Ruedy, Callyn Hall, Beth Stevens, Gilman D. Grave, Karen K. Winer, Ellen Leschek, Mark Sperling, Dorothy M. Becker, Patricia Cleary, Carla Greenbaum, Antoinette Moran, Michael W. Steffes, Jean M. Bucksa, Maren L. Nowicki, Vicky Makky

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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 HbA 1c 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 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. 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.

Original languageEnglish (US)
Pages (from-to)204-210
Number of pages7
JournalDiabetes care
Volume35
Issue number2
DOIs
StatePublished - Feb 1 2012

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    Mauras, N., Beck, R., Xing, D., Ruedy, K., Buckingham, B., Tansey, M., White, N. H., Weinzimer, S. A., Tamborlane, W., Kollman, C., Tsalikian, E., Tansey, M. J., Coffey, J., Cabbage, J., Salamati, S., Fox, L. A., Englert, K., Permuy, J., Sikes, K., ... Makky, V. (2012). 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, 35(2), 204-210. https://doi.org/10.2337/dc11-1746