Self-Administered 2-Hour Oral Glucose Tolerance Test

Study Overview
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Brief Summary
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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?

Detailed Description
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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.

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

Conditions
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Gestational Diabetes, Postpartum Disorder, Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Other: Self-administered oral glucose tolerance test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-administered diabetes screen<br>Self-administered 75-gram oral glucose tolerance test with 4-week virtual follow-up visit. Drug: GlucoCrush | Other: Self-administered oral glucose tolerance test<br>* 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.<br>|
| No Intervention: Routine postpartum care<br>Office based oral glucose tolerance test at 6 weeks postpartum, per normal protocol. Drug: GlucoCrush | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of 75-gram oral glucose tolerance test | 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 |