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

NCT05062460 | Completed

• 1 other identifier: 20-10022829
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Rate of adherence

  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.

  During the intervention

Secondary Outcomes (22)

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

  During the intervention

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

  During the intervention

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

  During the intervention

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

  During the intervention

• Gestational age at medication therapy initiation

  During the intervention

Study Arms (2)

1-hour post-prandial blood glucose monitoring Arm

OTHER

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

Other: 1 hour Blood glucose monitoring

2-hour post-prandial blood glucose monitoring Arm

OTHER

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

Other: 2 hour blood glucose monitoring

Interventions

1 hour Blood glucose monitoring OTHER

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

1-hour post-prandial blood glucose monitoring Arm

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

2-hour post-prandial blood glucose monitoring Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Prebyterian Hospital Weill Cornell

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Glucose

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

Intervention Hierarchy (Ancestors)

Glucose; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Stephen Chasen, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: September 30, 2021
• Study Start: July 15, 2021
• Primary Completion: June 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)