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

Primary Purpose

Gestational Diabetes

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

1 hour Blood glucose monitoring

2 hour blood glucose monitoring

About this trial

This is an interventional health services research trial for Gestational Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

New York Prebyterian Hospital Weill Cornell

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

1-hour post-prandial blood glucose monitoring Arm

2-hour post-prandial blood glucose monitoring Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

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

Gestational age at medication therapy initiation

Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy

Number of subjects with a vaginal delivery

Number of subjects with an operative delivery

Number of subjects with a caesarean section delivery

Number of subjects with a preeclampsia diagnosis

Neonatal birthweight

Number of subjects with shoulder dystocia

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

Number of patients with postpartum hemorrhage.

Number of stillbirths

Number of NICU admissions

Number of patients requiring supplemental oxygen support

Number of patients with diagnosis of hypoglycemia

Number of patients with diagnosis of hyperbilirubinemia

Number of patients with clavicular fracture

Number of patients with humeral fracture

Number of patients with brachial plexus palsy

Full Information

NCT ID

NCT05062460

First Posted

August 19, 2021

Last Updated

July 27, 2023

Sponsor

Weill Medical College of Cornell University

1. Study Identification

Unique Protocol Identification Number

NCT05062460

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

July 15, 2021 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1-hour post-prandial blood glucose monitoring Arm

Arm Type

Other

Arm Description

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

Arm Title

2-hour post-prandial blood glucose monitoring Arm

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

1 hour Blood glucose monitoring

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

2 hour blood glucose monitoring

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of adherence

Description

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.

Time Frame

During the intervention

Secondary Outcome Measure Information:

Title

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

Time Frame

During the intervention

Title

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

Title

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

Time Frame

During the intervention

Title

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

Time Frame

During the intervention

Title

Gestational age at medication therapy initiation

Time Frame

During the intervention

Title

Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy

Time Frame

During the intervention

Title

Number of subjects with a vaginal delivery

Time Frame

At time of delivery

Title

Number of subjects with an operative delivery

Time Frame

At time of delivery

Title

Number of subjects with a caesarean section delivery

Time Frame

At time of delivery

Title

Number of subjects with a preeclampsia diagnosis

Time Frame

During intervention

Title

Neonatal birthweight

Time Frame

At time of delivery

Title

Number of subjects with shoulder dystocia

Time Frame

At time of delivery

Title

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

Time Frame

At time of delivery

Title

Number of patients with postpartum hemorrhage.

Time Frame

At time of delivery

Title

Number of stillbirths

Time Frame

At time of delivery

Title

Number of NICU admissions

Time Frame

At time of delivery

Title

Number of patients requiring supplemental oxygen support

Time Frame

At time of delivery

Title

Number of patients with diagnosis of hypoglycemia

Time Frame

At time of delivery

Title

Number of patients with diagnosis of hyperbilirubinemia

Time Frame

At time of delivery

Title

Number of patients with clavicular fracture

Time Frame

At time of delivery

Title

Number of patients with humeral fracture

Time Frame

At time of delivery

Title

Number of patients with brachial plexus palsy

Time Frame

At time of delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Chasen, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Prebyterian Hospital Weill Cornell

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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