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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gestational Diabetes
• Intervention / Treatment: Other: 1 hour Blood glucose monitoring; Other: 2 hour blood glucose monitoring

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • New York Prebyterian Hospital Weill Cornell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1-hour post-prandial blood glucose monitoring Arm; Arm in which participants are randomized to blood glucose monitoring at 1 hour after eating.	Other: 1 hour Blood glucose monitoring; Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.
Other: 2-hour post-prandial blood glucose monitoring Arm; Arm in which participants are randomized to blood glucose monitoring at 2 hours after eating.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy	During the intervention
Number of subjects with a vaginal delivery	At time of delivery
Number of subjects with an operative delivery	At time of delivery
Number of subjects with a caesarean section delivery	At time of delivery
Number of subjects with a preeclampsia diagnosis	During intervention
Neonatal birthweight	At time of delivery
Number of subjects with shoulder dystocia	At time of delivery
Number of patients with 3rd or 4th degree perineal lacerations	At time of delivery
Number of patients with postpartum hemorrhage.	At time of delivery
Number of stillbirths	At time of delivery
Number of NICU admissions	At time of delivery
Number of patients requiring supplemental oxygen support	At time of delivery
Number of patients with diagnosis of hypoglycemia	At time of delivery
Number of patients with diagnosis of hyperbilirubinemia	At time of delivery
Number of patients with clavicular fracture	At time of delivery
Number of patients with humeral fracture	At time of delivery
Number of patients with brachial plexus palsy	At time of delivery

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Stephen Chasen, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes, Gestational
• Other Study ID Numbers: 20-10022829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No