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A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP)

Primary Purpose

Pre-Gestational Diabetes, Type2diabetes, Pregnancy in Diabetic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate inpatient postpartum OGTT
Standard of care 4-12 week postpartum OGTT
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Gestational Diabetes focused on measuring 2-hour oral glucose tolerance test (OGTT), Pregnancy, diabetes mellitus screening

Eligibility Criteria

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

Inclusion Criteria: Immediately postpartum individuals during their delivery hospital admission ≥ 18 years old with the ability to give informed consent. Diagnosed with gestational diabetes (GDM) during pregnancy by a one-hour 50-gram glucose challenge test ≥200 mg/dL at greater than 20 weeks of gestation or two elevated values on a 3-hour 100-gram glucose tolerance test at greater than 20 weeks of gestation (Carpenter/Coustan criteria). English or Spanish speaking Receiving prenatal and postpartum care at OSU Exclusion Criteria: Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass) Not English or Spanish speaking

Sites / Locations

  • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Immediate inpatient postpartum OGTT

Standard of care

Arm Description

The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge

Standard of care is 4-12 week outpatient postpartum OGTT

Outcomes

Primary Outcome Measures

Rate of postpartum diabetes mellitus screening
For patients randomized to inpatient immediate postpartum OGTT, completion of the inpatient test will be confirmed and documented by study staff prior to patient discharge. For patients randomized to the inpatient immediate postpartum OGTT who do not undergo inpatient testing and for patients randomized to the outpatient 4-12 week OGTT, individuals will receive an electronic survey via email at 12 weeks inquiring as to whether they underwent postpartum outpatient OGTT and about the results of testing, if performed.

Secondary Outcome Measures

Risk perception and lifestyle modification
"What do you think your risk or chance is for getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance.") "If you don't change your lifestyle behaviors, such as diet or exercise, what is your risk or chance of getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance.") "Have you recently made changes in any lifestyle behaviors that you believe will lower your chance of getting diabetes?" (Responses: yes, no) "Are you planning to make changes in any lifestyle behaviors in the near future that you believe will lower your chances of getting diabetes?" (Responses: yes, no)
Rates of primary care provider (PCP) visits within 1 year of delivery
All individuals will be sent an electronic survey via email inquiring as to whether they have attended a visit with a primary care provider (internal medicine, family medicine or primary care nurse practitioner) and for what reason since the time of their delivery.
Risk Perception Survey for Developing Diabetes
The survey comprises 53 items and has four subscales and other individual items to address various dimensions of risk perception. Risk perception will be assessed as both continuous scales and as a dichotomous outcome ("no chance" and "slight chance" will be categorized as "low" risk perception, and "moderate chance" and "high chance" will be categorized as "high" risk perception.
Diabetes Treatment Satisfaction Questionnaire
8 question survey will be scored as a continuous scale.
Prediabetes or type 2 diabetes
Prediabetes: OGTT between 140 to 199 mg/dl AND/OR A1c 5.7% to 6.4% AND/OR patient self-report Type 2 diabetes: OGTT 200 mg/dl or higher AND/OR A1c 6.5% or higher AND/OR patient self-report

Full Information

First Posted
June 9, 2023
Last Updated
July 27, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05909046
Brief Title
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP)
Official Title
A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.
Detailed Description
Individuals with gestational diabetes (GDM) during pregnancy have up to a 10-fold increased risk of developing of T2DM. Postpartum screening facilitates detection of impaired glucose tolerance and diabetes mellitus with the possibility for subsequent preventive and treatment interventions. The American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) recommend screening individuals with GDM postpartum with a 75-g, 2-hour oral glucose tolerance test (OGTT) that includes a fasting blood glu-cose.4,6 This is historically performed at 4-12 weeks so that it will coincide with the timing of the typical postpartum visit. However, the rate of postpartum screening with the recommended method are low, as many individuals do not seek timely postpartum care-only a quarter to one half of individuals undergo diabetes screening in the first year postpartum. Multiple structural barriers exist for patients and healthcare providers to effectively complete postpartum diabetes screening via the current recommended method. An immediate postpartum OGTT has been proposed as an alternative to the current standard practice which is generally performed between 4-12 week postpartum OGTT at the routine postpartum visit. An immediate OGTT has comparable performance characteristics for detection of impaired glucose tolerance and diabetes compared with a 4-12 week postpartum OGTT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Gestational Diabetes, Type2diabetes, Pregnancy in Diabetic, Pregnancy, High Risk, Gestational Diabetes, Gestational Diabetes Mellitus in the Puerperium
Keywords
2-hour oral glucose tolerance test (OGTT), Pregnancy, diabetes mellitus screening

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate inpatient postpartum OGTT
Arm Type
Active Comparator
Arm Description
The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge
Arm Title
Standard of care
Arm Type
Other
Arm Description
Standard of care is 4-12 week outpatient postpartum OGTT
Intervention Type
Diagnostic Test
Intervention Name(s)
Immediate inpatient postpartum OGTT
Intervention Description
The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard of care 4-12 week postpartum OGTT
Intervention Description
Standard of care is 4-12 week outpatient postpartum OGTT
Primary Outcome Measure Information:
Title
Rate of postpartum diabetes mellitus screening
Description
For patients randomized to inpatient immediate postpartum OGTT, completion of the inpatient test will be confirmed and documented by study staff prior to patient discharge. For patients randomized to the inpatient immediate postpartum OGTT who do not undergo inpatient testing and for patients randomized to the outpatient 4-12 week OGTT, individuals will receive an electronic survey via email at 12 weeks inquiring as to whether they underwent postpartum outpatient OGTT and about the results of testing, if performed.
Time Frame
From delivery to up to 12 weeks postpartum
Secondary Outcome Measure Information:
Title
Risk perception and lifestyle modification
Description
"What do you think your risk or chance is for getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance.") "If you don't change your lifestyle behaviors, such as diet or exercise, what is your risk or chance of getting diabetes over the next 10 years?" (Responses: "almost no chance," "a slight chance," "a moderate chance," or "a high chance.") "Have you recently made changes in any lifestyle behaviors that you believe will lower your chance of getting diabetes?" (Responses: yes, no) "Are you planning to make changes in any lifestyle behaviors in the near future that you believe will lower your chances of getting diabetes?" (Responses: yes, no)
Time Frame
From delivery to up to 12 weeks postpartum
Title
Rates of primary care provider (PCP) visits within 1 year of delivery
Description
All individuals will be sent an electronic survey via email inquiring as to whether they have attended a visit with a primary care provider (internal medicine, family medicine or primary care nurse practitioner) and for what reason since the time of their delivery.
Time Frame
Within 1 year postpartum
Title
Risk Perception Survey for Developing Diabetes
Description
The survey comprises 53 items and has four subscales and other individual items to address various dimensions of risk perception. Risk perception will be assessed as both continuous scales and as a dichotomous outcome ("no chance" and "slight chance" will be categorized as "low" risk perception, and "moderate chance" and "high chance" will be categorized as "high" risk perception.
Time Frame
From delivery to up to 12 weeks postpartum
Title
Diabetes Treatment Satisfaction Questionnaire
Description
8 question survey will be scored as a continuous scale.
Time Frame
From delivery to up to 12 weeks postpartum
Title
Prediabetes or type 2 diabetes
Description
Prediabetes: OGTT between 140 to 199 mg/dl AND/OR A1c 5.7% to 6.4% AND/OR patient self-report Type 2 diabetes: OGTT 200 mg/dl or higher AND/OR A1c 6.5% or higher AND/OR patient self-report
Time Frame
Within 1 year postpartum

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is restricted to pregnant individuals.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Immediately postpartum individuals during their delivery hospital admission ≥ 18 years old with the ability to give informed consent. Diagnosed with gestational diabetes (GDM) during pregnancy by a one-hour 50-gram glucose challenge test ≥200 mg/dL at greater than 20 weeks of gestation or two elevated values on a 3-hour 100-gram glucose tolerance test at greater than 20 weeks of gestation (Carpenter/Coustan criteria). English or Spanish speaking Receiving prenatal and postpartum care at OSU Exclusion Criteria: Individuals who cannot tolerate a 2-hour oral glucose tolerance test (OGTT) (i.e. history of gastric bypass) Not English or Spanish speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kartik Venkatesh, MD, PhD
Phone
614-293-2222
Email
kartik.venkatesh@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Field, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kartik K Venkatesh, MD, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kartik Venkatesh, MD, PhD
Phone
614-293-2222
Email
Kartik.Venkatesh@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP)

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