Exp Clin Endocrinol Diabetes 2006; 114(2): 63-67
DOI: 10.1055/s-2006-923887
Article

J. A. Barth Verlag in Georg Thieme Verlag KG Stuttgart · New York

Results of a Randomised Controlled Cross-Over Trial on the Effect of Continuous Subcutaneous Glucose Monitoring (CGMS) on Glycaemic Control in Children and Adolescents with Type 1 Diabetes

D. Deiss1 , R. Hartmann1 , J. Schmidt1 , O. Kordonouri1
  • 1Clinic of General Paediatrics, Otto-Heubner Centrum, Charité, Campus Virchow-Klinikum, Berlin, Germany
Weitere Informationen

Publikationsverlauf

Received: October 19, 2004 First decision: April 21, 2005

Accepted: November 28, 2005

Publikationsdatum:
29. März 2006 (online)

Abstract

Objective: To study the feasibility and the influence on glycaemic control of continuous glucose monitoring (CGMS) in young patients with type 1 diabetes. Design and Methods: A double-blinded, cross-over study was performed in 30 children (median age 11.1 years [range: 2.3 - 16.3], diabetes duration 2.1 years [0.2 - 7.1]). Patients were randomised into an open (A) or blind study arm (B). Both groups performed standardised self-monitoring blood glucose (SMBG) and received CGMS at the beginning of the study, at 3 and 6 months, each. In the blinded arm, patients and investigator were concealed from CGMS data. After 3 months, open and blinded study arms crossed over. Average glucose values and area under the glucose curve (AUC) per 24 h, above 180 and below 60 mg/dl were calculated from CGMS. Haemoglobin A1c (HbA1c) was measured at each study point. Results: Despite comparable clinical characteristics between the 15 patients of each arm, mean HbA1c was slightly lower in arm A than in B at baseline (7.8 ± 1.2 % vs. 8.4 ± 1.1 %, p = 0.148), at 3 months (7.8 ± 1.1 % vs. 8.3 ± 1.1 %, p = 0.233), and significantly lower at 6 months (7.6 ± 1.1 % vs. 8.5 ± 0.9 %, p = 0.026). However, no significant change of HbA1c occurred within each arm (A, p = 0.183 and B, p = 0.823), irrespectively whether CGMS data were blinded or not. Likewise, mean glucose and hyper- or hypoglycaemia values did not change significantly. Conclusions: In this setting, CGMS did not decisively influence glycaemic control of a total study cohort. More frequent use of CGMS at shorter intervals in single patients with hyper- or hypoglycaemic problems may be of greater value than SMBG.

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MD Olga Kordonouri

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