4 vs 7 points self-monitoring blood glucose in gestational diabetes mellitus on diet modification: randomised clinical trial in a single tertiary centre in Malaysia.

PURPOSE: There is no standardized best method on monitoring of patients with gestational diabetes on diet modification in the country. This study aims to investigate the optimum method of self-monitoring blood glucose.

METHODS

This is a randomized clinical trial in a single tertiary centre involving patients with gestational diabetes mellitus (GDM) diagnosed based on NICE guideline on diet modification. The patients are randomized in 1:1 ratio to 4 or 7 points self-monitoring blood glucose. The monitoring was required to be done monthly with ultrasound for fetal growth. Blood was taken at recruitment for measurement of serum HbA1c and fructosamine.

RESULTS

A total of 200 patients were recruited. There were significantly more Malay patients in the 7 points group (88.9% vs 78.2%, p = 0.033). Multiparous patients were significantly more in the 4 points group (82.2% vs 68.7%, p = 0.033). Both groups were similar in clinical characteristics. There was no statistical difference in the neonatal outcome particularly fetal macrosomia and admission to neonatal intensive care unit.

CONCLUSIONS

In patients with GDM on diet modification, self-blood glucose monitoring using either 4 or 7 points resulted in similar maternal and perinatal outcomes. The research was registered under ClinicalTrials.gov (NCT04101396) on 17/9/2019 ( https://register.

CLINICALTRIALS: gov/prs/app/action/SelectProtocol?sid=S00098EN&selectaction=Edit&uid=U0004RD4&ts=2&cx=-qlk1w2 ).