Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus

Gestational Diabetes Clinical Trial

Official title:

Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857073
• Other study ID #: IRB 20-01914
• Status: Completed
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: April 6, 2022

Study information

• Verified date: May 2022
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• Glucose Monitoring
Glucose monitoring consists of finger stick fasting and 2 hours post prandial

Locations

Country	Name	City	State
United States	Mount Sinai Perinatal Associates	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth weight	Fetal weight at time of delivery (grams).	Day 1 - day of delivery
Secondary	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
Secondary	Cord blood pH level		Day 1 - day of delivery
Secondary	Number of NICU admission		Day 1 - day of delivery