Self-Administered 2-Hour Oral Glucose Tolerance Test

November 13, 2023 updated by: Prisma Health-Upstate

Self-Administered 2-Hour Oral Glucose Tolerance Test: A Randomized Controlled Trial

The goal of this randomized controlled trial is to evaluate whether self-administered postpartum diabetes screening tests in patients with gestational diabetes improves screening completion rates. The primary question it aims to answer is:

1. Does a self-administered 75-gram oral glucose tolerance test with virtual follow-up visit increase the rate of postpartum diabetes screening within 12 weeks of delivery?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gestational diabetes affects up to 10% of pregnancies, with increasing prevalence. Due to the risk of developing overt type 2 diabetes mellitus, patients are recommended to complete postpartum diabetes screening within 4-12 weeks of delivery. Despite these recommendations, screening rates remain low. Research evaluating reasons for low screening have identified social barriers like lack of transportation or childcare, as well as health literacy barriers. The consequences of missed screening include delay in diagnosis, delay in care, and ultimately higher health burden for the patient and the healthcare system.

This study seeks to evaluate a novel approach to increase uptake of recommended postpartum diabetes screening. The primary objective of this study is to determine if a self-administered postpartum diabetes screen (75-gram oral glucose tolerance test) increases screening completion rates. Our hypothesis is that the ability to perform the 75-gram oral glucose tolerance test at home will improve compliance with screening.

Additionally, we will evaluate the level of patient satisfaction with virtual follow-up in the intervention arm as a pre-specified additional outcome.

Eligible, consenting participants will be enrolled and randomized in a 1:1 ratio to the control arm (routine postpartum care with office-based diabetes screen) or intervention arm (self-administered diabetes screen). The randomization sequence will be generated by the study statistician using a block design. Investigators will remain masked to the randomization sequence.

All participants will be asked to complete a brief survey containing patient characteristics and two questions about perceived risk. Additional patient and neonatal data will be abstracted from the electronic medical record. All information will be stored in a secure password protected database.

Participants allocated to the intervention arm will receive the 75-gram oral glucose load and instructions prior to hospital discharge. The test should be administered approximately 4 weeks after delivery, and this date will be provided. They will be scheduled for a virtual visit approximately 4 weeks after delivery to report their results and discuss appropriate follow-up. Following this visit, participants will be asked to complete a modified version of the Telehealth Usability Questionnaire. The questionnaire contains five questions about their satisfaction with their telemedicine experience. The scoring is based on a likert scale, 1-7, with higher scores indicating higher satisfaction. If patients do not attend their 4-week virtual visit, they will be contacted one additional time to complete.

Participants will be scheduled for a routine 6-week postpartum visit.

Control arm participants will attend their routine 6-week postpartum visit where the postpartum diabetes glucose screen will be ordered. They can complete the test that day if they are fasting or will be responsible for arranging test completion on another day.

The study will conclude 12 weeks after delivery for each participant. At that time, any patients who have not completed the recommended postpartum diabetes screening will be contacted to ensure they have not completed screening outside of our health system/electronic medical record. If they are successfully contacted, they will be reported in intent-to-treat fashion based on self-reported completion of recommended screening.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Maternal age 18 years or older
  • English or Spanish speaking
  • Diagnosis of gestational diabetes with recommendation for postpartum screening, by any of the following criteria (1) HgbA1c 5.9-6.4% at ≤ 14 6/7 weeks, (2) HgbA1c ≥ 5.9% at 15-23 6/7 weeks, (3) 50-gram oral glucose tolerance test plasma glucose value ≥ 200 mg/dL, (4) 2 or more abnormal plasma glucose values on a 100-gram oral glucose tolerance test with the following thresholds: fasting ≥ 95 mg/dL, 1 hour ≥ 180 mg/dL, 2 hour ≥155 mg/dL, 3 hour ≥140 mg/dL or (5) fasting blood glucose ≥ 126
  • No personal history of Type 1 or Type 2 diabetes defined by self-reported or documented history, or HgbA1c >/=6.5% at ≤ 14 6/7 weeks gestation
  • Antepartum care with Prisma Health affiliated obstetric practices
  • Delivery at Greenville Memorial Hospital
  • Active Epic MyChart access at time of enrollment
  • Capable of providing informed consent

Exclusion Criteria:

  • Pre-pregnancy diagnosis of diabetes (Type 1, 2, or other form of diabetes)
  • No glucometer or supplies for fingerstick glucose monitoring, or inability to perform fingerstick glucose monitoring
  • Unable to provide informed consent
  • Inability to follow up for routine postpartum care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-administered diabetes screen

Self-administered 75-gram oral glucose tolerance test with 4-week virtual follow-up visit.

Drug: GlucoCrush
Other: Self-administered oral glucose tolerance test
Participants will be asked to self-administer the postpartum 75-gram oral glucose tolerance test. They will be provided the glucose solution and instructions. A 4 week virtual visit will be arranged where the test results will be reported to the provider and appropriate follow up arranged based on the results of their screen.
No Intervention: Routine postpartum care

Office based oral glucose tolerance test at 6 weeks postpartum, per normal protocol.

Drug: GlucoCrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of 75-gram oral glucose tolerance test
Time Frame: within 12 weeks of delivery
A comparison of the proportion of patients in each arm (intervention vs control) who complete recommended postpartum diabetes screening within 12 weeks of delivery. For the intervention arm, this will be completion of the self-administered 75-gram oral glucose tolerance test. For the control arm, this will be completion of the in-office 75-gram glucose tolerance test. The test will be considered completed in either arm if the patient has a fasting blood glucose >/=126 mg/dL (diagnostic of type 2 diabetes and does not require a post glucose load value), or both fasting and 2-hour post 75-gram glucose load blood glucose levels are documented.
within 12 weeks of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance at routine postpartum visit
Time Frame: within 12 weeks of delivery
Proportion of patients who have documentation of attending an in-office visit with an obstetrics provider within 12 weeks of delivery. The visit will be considered a postpartum visit if the typical components of a postpartum partum visit are addressed (i.e. physical healing, postpartum mood assessment, breastfeeding assessment). Visits with non-obstetric specialists, emergency department visits, and nursing visits are not included in this outcome measure.
within 12 weeks of delivery
Patient satisfaction
Time Frame: within 12 weeks of delivery

Patient satisfaction will only be assessed in the intervention arm. Satisfaction with their virtual visit will be assessed by evaluating scores from a modified version of the Telehealth Usability Questionnaire. This modified version contains 5 questions about satisfaction with telemedicine. The scoring is based on a likert scale, 1-7. 1 = strongly disagree, 7 = strongly agree, with higher scores indicating higher satisfaction.

  1. Telehealth improves my access to healthcare services.
  2. Telehealth provides for my healthcare need.
  3. Telehealth is an acceptable way to receive healthcare services.
  4. I would use telehealth services again.
  5. Overall, I am satisfied with this telehealth system.
within 12 weeks of delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: within 12 weeks of delivery

Patient satisfaction will only be assessed in the intervention arm. Satisfaction with their virtual visit will be assessed by evaluating scores from a modified version of the Telehealth Usability Questionnaire. This modified version contains 5 questions about satisfaction with telemedicine. The scoring is based on a likert scale, 1-7. 1 = strongly disagree, 7 = strongly agree, with higher scores indicating higher satisfaction.

  1. Telehealth improves my access to healthcare services.
  2. Telehealth provides for my healthcare need.
  3. Telehealth is an acceptable way to receive healthcare services.
  4. I would use telehealth services again.
  5. Overall, I am satisfied with this telehealth system.
within 12 weeks of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Investigators

  • Principal Investigator: Amy Crockett, MD, Prisma Health-Upstate

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2097104

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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