Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: Glucose Monitoring

Detailed Description

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. In the study team's practice, once a patient is diagnosed with GDM, they are enrolled in the Diabetes in Pregnancy program, undergo nutritional education, diabetes education and have their care overseen by a Maternal-Fetal Medicine specialist. 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. In 2017, a randomized control trial was performed by Menedez-Figeroa et al, showing non inferiority in patients diagnosed with GDM who were instructed to perform every other day (4 time daily) glucose monitoring versus daily (4 times daily) glucose monitoring with their primary outcome being a 5% change in birthweight between groups at delivery. 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 with the primary outcome being a 0% difference in birth weight. The study team will be enrolling approximately 300 patients. If a patient is enrolled in the study, there will be no excursion from normally scheduled visits (including follow ups), medications regimens, or procedure (including ultrasounds). They will remain in the Diabetes in Pregnancy program throughout their pregnancy. Participants will be enrolled at the first visit with the high risk doctor, and they will be asked to perform standard (4x daily) fingerstick monitoring, or every other day fingerstick monitoring (4x daily, every other day). Data collected from the patient (including labs, and fingerstick glucose values) will not be exclusively for research purposes, and will be collected as a routine part of the patients care

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai Perinatal Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Singleton pregnancies in women 18 years or older
• Diagnosis of GDM between 24 to 28 weeks gestation

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group - glucose check every day; Patients will be instructed to check their glucose 4 times a day, every day. This is currently the standard of care.	Other: Glucose Monitoring; Glucose monitoring consists of finger stick fasting and 2 hours post prandial; Other Names: Fingerstick
Experimental: Experimental group - glucose check every other day; Patients will be instructed to check their glucose every other day, 4 times glucose monitoring	Other: Glucose Monitoring; Glucose monitoring consists of finger stick fasting and 2 hours post prandial; Other Names: Fingerstick

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birth weight	Fetal weight at time of delivery (grams).	Day 1 - day of delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APGAR score	APGAR measures the baby's color, heart rate, reflexes, muscle tone, and respiratory effort and total score from 1 to 10, with higher score indicating better health outcomes	Day 1 - day of delivery
Cord blood pH level		Day 1 - day of delivery
Number of NICU admission		Day 1 - day of delivery

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Kristina M Feldman, DO, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Actual): April 6, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: IRB 20-01914

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No