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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05062460
• Other study ID #: 20-10022829
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Other:
• 1 hour Blood glucose monitoring
Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.
• 2 hour blood glucose monitoring
Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring

Locations

Country	Name	City	State
United States	New York Prebyterian Hospital Weill Cornell	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of postprandial glucose log complete, averaged over the duration of the study period		During the intervention
Secondary	Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period		During the intervention
Secondary	Percentage of elevated blood glucose values per week, averaged over the duration of the study period		During the intervention
Secondary	Number of patients who start insulin or oral hyperglycemic medication therapy prior to delivery.		During the intervention
Secondary	Gestational age at medication therapy initiation		During the intervention
Secondary	Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy		During the intervention
Secondary	Number of subjects with a vaginal delivery		At time of delivery
Secondary	Number of subjects with an operative delivery		At time of delivery
Secondary	Number of subjects with a caesarean section delivery		At time of delivery
Secondary	Number of subjects with a preeclampsia diagnosis		During intervention
Secondary	Neonatal birthweight		At time of delivery
Secondary	Number of subjects with shoulder dystocia		At time of delivery
Secondary	Number of patients with 3rd or 4th degree perineal lacerations		At time of delivery
Secondary	Number of patients with postpartum hemorrhage.		At time of delivery
Secondary	Number of stillbirths		At time of delivery
Secondary	Number of NICU admissions		At time of delivery
Secondary	Number of patients requiring supplemental oxygen support		At time of delivery
Secondary	Number of patients with diagnosis of hypoglycemia		At time of delivery
Secondary	Number of patients with diagnosis of hyperbilirubinemia		At time of delivery
Secondary	Number of patients with clavicular fracture		At time of delivery
Secondary	Number of patients with humeral fracture		At time of delivery
Secondary	Number of patients with brachial plexus palsy		At time of delivery