Gestational DiabetesNCT06099509
Self-Administered 2-Hour Oral Glucose Tolerance Test
A study testing Self-administered oral glucose tolerance test in people with Gestational Diabetes and Postpartum Disorder, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Postpartum Disorder, Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Self-administered oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health/Greenville Memorial Hospital
Greenville, South Carolina, 29605
About this study
Official title: 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:
- 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?
Read the 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.
- Being tested
- Self-administered oral glucose tolerance test
- Medical subject headings
- Diabetes, Gestational, Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered oral glucose tolerance testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-administered diabetes screen | Experimental | Self-administered 75-gram oral glucose tolerance test with 4-week virtual follow-up visit.
Drug: GlucoCrush Receives: Other: Self-administered oral glucose tolerance test |
| Routine postpartum care | No intervention | Office based oral glucose tolerance test at 6 weeks postpartum, per normal protocol. Drug: GlucoCrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 12 weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start2 Nov 2023
- Primary completion28 Feb 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Crockett, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099509
- Sponsor's protocol ID
- 2097104
- Status last verified
- Jun 2025
- First submitted
- 18 Oct 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Quintanilla Rodriguez BS, Mahdy H. Gestational Diabetes. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK545196/
Blum AK. Insulin Use in Pregnancy: An Update. Diabetes Spectr. 2016 May;29(2):92-7. doi: 10.2337/diaspect.29.2.92.
PubMed 27182178"Gestational Diabetes Mellitus." ACOG Practice Bulletin, vol. 190, Feb. 2018, https://doi.org/https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2018/02/gestational-diabetes-mellitus.
Tovar A, Chasan-Taber L, Eggleston E, Oken E. Postpartum screening for diabetes among women with a history of gestational diabetes mellitus. Prev Chronic Dis. 2011 Nov;8(6):A124. Epub 2011 Oct 17.
PubMed 22005617"Gestational Diabetes." Centers for Disease Control and Prevention, 2 Mar. 2022, www.cdc.gov/diabetes/basics/gestational.html#:~:text=Every%20year%2C%202%25%20to%2010,pregnancy%20and%20a%20healthy%20baby.
Vounzoulaki E, Khunti K, Abner SC, Tan BK, Davies MJ, Gillies CL. Progression to type 2 diabetes in women with a known history of gestational diabetes: systematic review and meta-analysis. BMJ. 2020 May 13;369:m1361. doi: 10.1136/bmj.m1361.
PubMed 32404325Sinha DD, Williams RC, Hollar LN, Lucas HR, Johnson-Javois B, Miller HB, Stoermer A, Colditz GA, James AS, Herrick CJ. Barriers and facilitators to diabetes screening and prevention after a pregnancy complicated by gestational diabetes. PLoS One. 2022 Nov 18;17(11):e0277330. doi: 10.1371/journal.pone.0277330. eCollection 2022.
PubMed 36399472Dennison RA, Fox RA, Ward RJ, Griffin SJ, Usher-Smith JA. Women's views on screening for Type 2 diabetes after gestational diabetes: a systematic review, qualitative synthesis and recommendations for increasing uptake. Diabet Med. 2020 Jan;37(1):29-43. doi: 10.1111/dme.14081. Epub 2019 Jul 22.
PubMed 31317569Nielsen KK, Kapur A, Damm P, de Courten M, Bygbjerg IC. From screening to postpartum follow-up - the determinants and barriers for gestational diabetes mellitus (GDM) services, a systematic review. BMC Pregnancy Childbirth. 2014 Jan 22;14:41. doi: 10.1186/1471-2393-14-41.
PubMed 24450389
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Administered 2-Hour Oral Glucose Tolerance Test: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06099509
- Acronym / sponsor ID
- 2097104
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-administered diabetes screen | Experimental | Other: Self-administered oral glucose tolerance testSelf-administered 75-gram oral glucose tolerance test with 4-week virtual follow-up visit. Drug: GlucoCrush |
| Routine postpartum care | No intervention | –Office based oral glucose tolerance test at 6 weeks postpartum, per normal protocol. Drug: GlucoCrush |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered oral glucose tolerance testParticipants 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. | Other | Self-administered diabetes screen |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- BackgroundQuintanilla Rodriguez BS, Mahdy H. Gestational Diabetes. [Updated 2023 Aug 8]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK545196/
- Background: PubMed 27182178Blum AK. Insulin Use in Pregnancy: An Update. Diabetes Spectr. 2016 May;29(2):92-7. doi: 10.2337/diaspect.29.2.92.
- Background"Gestational Diabetes Mellitus." ACOG Practice Bulletin, vol. 190, Feb. 2018, https://doi.org/https://www.acog.org/clinical/clinical-guidance/practice-bulletin/articles/2018/02/gestational-diabetes-mellitus.
- Background: PubMed 22005617Tovar A, Chasan-Taber L, Eggleston E, Oken E. Postpartum screening for diabetes among women with a history of gestational diabetes mellitus. Prev Chronic Dis. 2011 Nov;8(6):A124. Epub 2011 Oct 17.
- Background"Gestational Diabetes." Centers for Disease Control and Prevention, 2 Mar. 2022, www.cdc.gov/diabetes/basics/gestational.html#:~:text=Every%20year%2C%202%25%20to%2010,pregnancy%20and%20a%20healthy%20baby.
- Background: PubMed 32404325Vounzoulaki E, Khunti K, Abner SC, Tan BK, Davies MJ, Gillies CL. Progression to type 2 diabetes in women with a known history of gestational diabetes: systematic review and meta-analysis. BMJ. 2020 May 13;369:m1361. doi: 10.1136/bmj.m1361.
- Background: PubMed 36399472Sinha DD, Williams RC, Hollar LN, Lucas HR, Johnson-Javois B, Miller HB, Stoermer A, Colditz GA, James AS, Herrick CJ. Barriers and facilitators to diabetes screening and prevention after a pregnancy complicated by gestational diabetes. PLoS One. 2022 Nov 18;17(11):e0277330. doi: 10.1371/journal.pone.0277330. eCollection 2022.
- Background: PubMed 31317569Dennison RA, Fox RA, Ward RJ, Griffin SJ, Usher-Smith JA. Women's views on screening for Type 2 diabetes after gestational diabetes: a systematic review, qualitative synthesis and recommendations for increasing uptake. Diabet Med. 2020 Jan;37(1):29-43. doi: 10.1111/dme.14081. Epub 2019 Jul 22.
- Background: PubMed 24450389Nielsen KK, Kapur A, Damm P, de Courten M, Bygbjerg IC. From screening to postpartum follow-up - the determinants and barriers for gestational diabetes mellitus (GDM) services, a systematic review. BMC Pregnancy Childbirth. 2014 Jan 22;14:41. doi: 10.1186/1471-2393-14-41.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Crockett, MD principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered oral glucose tolerance test in people with Gestational Diabetes and Postpartum Disorder, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of 75-gram oral glucose tolerance test (time frame: within 12 weeks of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06099509, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.