Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus
Completed · Not applicable
Conditions studied: Gestational Diabetes
In brief
Gestational diabetes mellitus (GDM) occurs secondary to carbohydrate intolerance in pregnancy. Screening of GDM occurs between 24 to 28 weeks gestation by a screening 1-hour 50g glucose challenge test and confirmed with a 100g 3-hour fasting glucose tolerance test. Once patients are diagnosed with GDM, they are instructed to check their fingerstick blood glucose four times daily, every day. There is insufficient evidence to determine the ideal frequency and timing of glucose monitoring in patients diagnosed with GDM and no absolute guidelines put in place by the American College of Obstetricians and Gynecologists (ACOG). The study team aims to confirm non inferiority on the patient population on the effects of daily (4x daily) versus every other day (4x daily) glucose monitoring in all patients diagnosed with GDM.
Key facts
- Study ID
- NCT04857073
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 200
- Starts
- 2021-04-10
- Expected to finish
- 2022-04-06
- Last updated by the study team
- 2022-05-03
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Singleton pregnancies in women 18 years or older
- Diagnosis of GDM between 24 to 28 weeks gestation
You may not qualify if…
- Preexisting diabetes mellitus or GDM diagnosed prior to 24 weeks by early GDM screening (including patients currently on insulin or any oral hypoglycemic agent)
- Diagnosis of GDM based on fingerstick paneling
- Women who are on chronic steroid therapy
- Multifetal gestation
- Patients with GTT fasting value >100 (which would indicate a diagnosis of pre-diabetes according to the American Diabetes Association)
- Patients who exhibited poor compliance after the first two weeks of glucose monitoring (which is defined as less than 20% of expected values recorded during the 2 week period of initial testing)
Where it is running
- Mount Sinai Perinatal Associates — New York, New York, United States
Full record on ClinicalTrials.gov
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