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

NCT ID: NCT05062460

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-15

Study Completion Date

2025-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1-hour post-prandial blood glucose monitoring Arm

Arm in which participants are randomized to blood glucose monitoring at 1 hour after eating.

Group Type OTHER

1 hour Blood glucose monitoring

Intervention Type OTHER

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

2-hour post-prandial blood glucose monitoring Arm

Arm in which participants are randomized to blood glucose monitoring at 2 hours after eating.

Group Type OTHER

2 hour blood glucose monitoring

Intervention Type OTHER

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

Interventions

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1 hour Blood glucose monitoring

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

Intervention Type OTHER

2 hour blood glucose monitoring

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Chasen, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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New York Prebyterian Hospital Weill Cornell

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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20-10022829

Identifier Type: -

Identifier Source: org_study_id

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