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

TitleA 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
Publication TypeJournal Article
Year of Publication2012
AuthorsMauras, N., Beck R., Xing D., Ruedy K., Buckingham B., Tansey M., White N. H., Weinzimer S. A., Tamborlane W., & Kollman C.
Corporate AuthorsDiabetes Research in Children Network(DirecNet) Study Group
JournalDiabetes Care
Volume35
Issue2
Pagination204-10
Date Published2012 Feb
ISSN1935-5548
KeywordsBlood Glucose; Blood Glucose Self-Monitoring; Child; Child, Preschool; Diabetes Mellitus, Type 1; Female; Hemoglobin A, Glycosylated; Humans; Hypoglycemic Agents; Insulin; Male
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.




DOI10.2337/dc11-1746
Alternate JournalDiabetes Care
Refereed DesignationRefereed