Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus

NCT04857073 | Completed

• 1 other identifier: IRB 20-01914
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes

Keywords

glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Birth weight

  Fetal weight at time of delivery (grams).

  Day 1 - day of delivery

Secondary Outcomes (3)

• APGAR score

  Day 1 - day of delivery

• Cord blood pH level

  Day 1 - day of delivery

• Number of NICU admission

  Day 1 - day of delivery

Study Arms (2)

Control group - glucose check every day

ACTIVE COMPARATOR

Patients will be instructed to check their glucose 4 times a day, every day. This is currently the standard of care.

Other: Glucose Monitoring

Experimental group - glucose check every other day

EXPERIMENTAL

Patients will be instructed to check their glucose every other day, 4 times glucose monitoring

Other: Glucose Monitoring

Interventions

Glucose Monitoring OTHER

Glucose monitoring consists of finger stick fasting and 2 hours post prandial

Also known as: Fingerstick

Control group - glucose check every day; Experimental group - glucose check every other day

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Perinatal Associates

New York, New York, 10019, United States

Location

Related Publications (2)

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

  PMID: 29370047 BACKGROUND

• Feldman KM, Coughlin A, Feliciano J, Stoffels G, Wang KZ, Strauss TS, Grubman O, Al-Ibraheemi Z, Cole D, Ashmead G, Hussain F, Shchur SS, Lee D, Brustman L. Neonatal Birth Weight With Daily Compared With Every-Other-Day Glucose Monitoring in Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2024 Nov 1;144(5):707-714. doi: 10.1097/AOG.0000000000005528. Epub 2024 Feb 8.

  PMID: 38330409 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kristina M Feldman, DO

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maternal Fetal Medicine Fellow

Model Details: Patients will be randomized into one of two arms 1. daily, 4 times a day glucose monitoring (fasting, 2 hours post prandial x 3) 2. every other day, 4 times daily glucose monitoring (fasting, 2 hours post prandial x 3)

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: April 10, 2021
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-05

Locations

US (1)