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

Arch Gynecol Obstet. 2024 Oct;310(4):1959-1965. doi: 10.1007/s00404-024-07661-5. Epub 2024 Aug 7.

Abstract

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 ).

Keywords: Maternal; Outcome; Perinatal; Policy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Blood Glucose / analysis
  • Blood Glucose / metabolism
  • Blood Glucose Self-Monitoring*
  • Diabetes, Gestational* / blood
  • Diabetes, Gestational* / diagnosis
  • Diabetes, Gestational* / diet therapy
  • Female
  • Fetal Macrosomia / prevention & control
  • Fructosamine / blood
  • Glycated Hemoglobin* / analysis
  • Humans
  • Infant, Newborn
  • Malaysia
  • Pregnancy
  • Tertiary Care Centers

Substances

  • Glycated Hemoglobin
  • Blood Glucose
  • Fructosamine

Associated data

  • ClinicalTrials.gov/NCT04101396