Continuous glucose monitoring system versus self-monitoring blood glucose in type 1 diabetes children (RoSEC) : a randomized controlled trial
Background A single centre, randomized, 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. Objectives The primary and secondary objectives were to compare t...
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| Main Author: | |
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| Format: | Thesis |
| Language: | English |
| Published: |
2020
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| Subjects: | |
| Online Access: | http://eprints.usm.my/50306/1/Muhd%20Alwi%20Muhd%20Helmi-24%20pages.pdf |
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| Summary: | Background
A single centre, randomized, 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.
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).
Intervention
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) were based on SMBG. Monthly average blood sugar level (BSL) and monthly mean hypoglycemic events per week (HE/wk) were measured at baseline, first month, the 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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