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 Nelly Mauras  1 , Roy Beck, Dongyuan Xing, Katrina Ruedy, Bruce Buckingham, Michael Tansey, Neil H White, Stuart A Weinzimer, William Tamborlane, Craig Kollman; Diabetes Research in Children Network (DirecNet) Study Group Collaborators, Affiliations Expand Collaborators Diabetes Research in Children Network (DirecNet) Study Group: Eva Tsalikian, Michael J Tansey, Julie Coffey, Joanne Cabbage, Sara Salamati, Nelly Mauras, Larry A Fox, Kim Englert, Joe Permuy, Kaitlin Sikes, Bruce A Buckingham, Darrell M Wilson, Paula Clinton, Kimberly Caswell, Stuart A Weinzimer, William V Tamborlane, Jennifer Sherr, Amy Steffen, Kate Weyman, Melinda Zgorski, Eileen Tichy, Neil H White, Ana Maria Arbelaez, Lucy Levandoski, Angie Starnes, Roy W Beck, Katrina J Ruedy, Craig Kollman, Dongyuan Xing, 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 Affiliation 1 Division of Pediatric Endocrinology, Nemours Children's Clinic, Jacksonville, Florida, USA. direcnet@jaeb.org PMID: 22210571 PMCID: PMC3263860 DOI: 10.2337/dc11-1746 Free PMC article Item in Clipboard

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.

Trial registration: ClinicalTrials.gov NCT00760526.

Figures

Figure 1

Sensor use during the 26 weeks of the trial. Each box represents the number of hours per week of CGM sensor glucose data averaged over 4 weeks. The top and bottom of the boxes represent the 75th and 25th percentiles, respectively; the horizontal line within each box represents the median; and the black dot represents the mean. For participants who dropped from the trial, sensor use was considered to be zero after the day of dropout. Data were considered missing when downloaded glucose data were not available for a 4-week period. *Sensor download was unavailable due to device issue for one subject in 22–26 weeks.