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Gestational DiabetesNCT04857073

Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus

A study testing Glucose Monitoring in people with Gestational Diabetes, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes
What is being tested?
Glucose Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
10 Apr 2021to 6 Apr 2022
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mount Sinai Perinatal Associates

    New York, New York, 10019

Other trials in United States

About this study

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.

Read the 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

Being tested
Glucose Monitoring
Keywords
glucose monitoring
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glucose MonitoringOther

    Also called Fingerstick

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

Study groups in NCT04857073
Study groupRoleWhat they receive
Control group - glucose check every dayActive comparatorPatients will be instructed to check their glucose 4 times a day, every day. This is currently the standard of care.
Receives: Other: Glucose Monitoring
Experimental group - glucose check every other dayExperimentalPatients will be instructed to check their glucose every other day, 4 times glucose monitoring
Receives: Other: Glucose Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Birth weight

    Fetal weight at time of delivery (grams).

    Measured: Day 1 - day of delivery

Secondary outcomes (3)
  1. 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

    Measured: Day 1 - day of delivery

  2. Cord blood pH level

    Measured: Day 1 - day of delivery

  3. Number of NICU admission

    Measured: Day 1 - day of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2021
  2. Study start10 Apr 2021
  3. Primary completion6 Apr 2022
  4. Study completion6 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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)
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04857073
Sponsor's protocol ID
IRB 20-01914
Status last verified
May 2022
First submitted
20 Apr 2021
Last updated
3 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

    PubMed 29370047
  • 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.

    PubMed 38330409

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