Skip to main content
OpenTrials
Completed

NCT Number: NCT05062460

Glucose Testing in GDM: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics

The purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating.

The primary objective of this study is to evaluate difference in rate of adherence (binary outcome defined as <80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York Prebyterian Hospital Weill Cornell

New York, 10021, United States

About this study

Consented patients who are diagnosed with gestational diabetes will be randomized to either 1-hour or 2-hour postprandial blood glucose monitoring. A retrospective chart review from July 2020 until study commencement for patients from the same clinic will be used as a historical control group. This study will assess differences in adherence to testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant patients with singleton gestation who are ≥ 18 years of age.
  • Diagnosis of GDM after 24 0/7 weeks.
  • For diagnosing GDM, a two-step screening algorithm will be performed according to the American College of Obstetrics and Gynecologists.4 Specifically, a 1-hour 50-g glucose-loading test is given first. Plasma glucose levels between 140 and 200 mg/dL will be considered elevated. Confirmatory testing will then be performed using a 3-hour 100-g glucose tolerance test. Diagnosis was made when two of the four values were elevated. Abnormal glucose value thresholds are established via the criteria suggested by Carpenter and Coustan: fasting value ≥ 95 mg/dL, 1-hour ≥ 180 mg/dL, 2-hour ≥ 155 mg/dL, and 3-hour ≥ 140 mg/dL.9 Patients with a blood glucose level greater than 200 mg/dL after 1-hour 50-g glucose-loading test will be diagnosed with GDM without requirement for the 3-hour 100-g glucose tolerance test.

Exclusion criteria

  • Type 1 pre-gestational diabetes
  • Type 2 pre-gestational diabetes
  • GDM diagnosed prior to 24 0/7 weeks gestation.

Treatment and study plan

1 hour Blood glucose monitoring

Other

Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.

2 hour blood glucose monitoring

Other

Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring

Primary outcomes

  1. Rate of adherence

    Time frame: During the intervention

    Evaluate rate of adherence (binary outcome defined as <80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.

Secondary outcomes

  1. Percentage of postprandial glucose log complete, averaged over the duration of the study period

    Time frame: During the intervention

  2. Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period

    Time frame: During the intervention

  3. Percentage of elevated blood glucose values per week, averaged over the duration of the study period

    Time frame: During the intervention

  4. Number of patients who start insulin or oral hyperglycemic medication therapy prior to delivery.

    Time frame: During the intervention

  5. Gestational age at medication therapy initiation

    Time frame: During the intervention

  6. Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy

    Time frame: During the intervention

  7. Number of subjects with a vaginal delivery

    Time frame: At time of delivery

  8. Number of subjects with an operative delivery

    Time frame: At time of delivery

  9. Number of subjects with a caesarean section delivery

    Time frame: At time of delivery

  10. Number of subjects with a preeclampsia diagnosis

    Time frame: During intervention

  11. Neonatal birthweight

    Time frame: At time of delivery

  12. Number of subjects with shoulder dystocia

    Time frame: At time of delivery

  13. Number of patients with 3rd or 4th degree perineal lacerations

    Time frame: At time of delivery

  14. Number of patients with postpartum hemorrhage.

    Time frame: At time of delivery

  15. Number of stillbirths

    Time frame: At time of delivery

  16. Number of NICU admissions

    Time frame: At time of delivery

  17. Number of patients requiring supplemental oxygen support

    Time frame: At time of delivery

  18. Number of patients with diagnosis of hypoglycemia

    Time frame: At time of delivery

  19. Number of patients with diagnosis of hyperbilirubinemia

    Time frame: At time of delivery

  20. Number of patients with clavicular fracture

    Time frame: At time of delivery

  21. Number of patients with humeral fracture

    Time frame: At time of delivery

  22. Number of patients with brachial plexus palsy

    Time frame: At time of delivery

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics: A Randomized Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Sep 30, 2021
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.