Bachok, Norsaadah and Hussain, Suhaimi and Muhd Helmi, Muhd Alwi
(2021)
Continuous glucose monitoring system versus self-monitoring blood glucose in type 1 diabetes mellitus children (RoSEC): a randomized controlled trial.
Malaysian Journal of Paediatrics and Child Health (MJPCH), 27 (2).
pp. 51-68.
ISSN 1511-4511
Abstract
Objectives: The primary and secondary objectives were to compare the glycaemic control and frequency
of hypoglycaemia between continuous glucose monitoring system (CGMS) and self-monitoring blood
glucose (SMBG). Methods: A single centre, randomised, parallel-group controlled trial was conducted
involving twenty-two type one Diabetes Mellitus (T1DM) patients with the mean age of 13.8 years
assigned to either intervention or control group. All respondents wore the CGMS device at the beginning
of the study. Intervention group (n=11) had their insulin adjusted based on the CGMS data, while the
control group (n=11) was based on SMBG. Monthly average blood sugar level (BSL) and monthly mean
hypoglycemic events per week (HE/wk) were measured at baseline, first month, second month, and third
month. HbA1c levels were measured at baseline and in the third month. Results: The baseline
characteristics were similar. The data were analysed using repeated measure analysis of variance
(ANOVA). The mean difference of HbA1c within the group was not statistically significant with p=0.322.
There were significant differences in the monthly mean HE/wk within and between groups, p=0.004, and
p=0.037. Conclusion: In conclusion, CGMS is equivalent to SMBG in optimising glycaemic control but is
more effective in detecting hypoglycaemia in children.
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