Self-Administered 2-Hour Oral Glucose Tolerance Test

NCT06099509 | Completed

• 1 other identifier: 2097104
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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\. 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?

Conditions

Gestational Diabetes; Postpartum Disorder; Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Patient satisfaction

  within 12 weeks of delivery

Study Arms (2)

Self-administered diabetes screen

EXPERIMENTAL

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

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

Interventions

Self-administered oral glucose tolerance test OTHER

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.

Self-administered diabetes screen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prisma Health-Upstate: lead

Study Sites (1)

Prisma Health/Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

Related Publications (9)

• 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/

  BACKGROUND

• Blum AK. Insulin Use in Pregnancy: An Update. Diabetes Spectr. 2016 May;29(2):92-7. doi: 10.2337/diaspect.29.2.92.

  PMID: 27182178 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

• 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.

  PMID: 22005617 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

• 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.

  PMID: 32404325 BACKGROUND

• Sinha 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.

  PMID: 36399472 BACKGROUND

• Dennison 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.

  PMID: 31317569 BACKGROUND

• Nielsen 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.

  PMID: 24450389 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Puerperal Disorders

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Amy Crockett, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 25, 2023
• Study Start: November 2, 2023
• Primary Completion: February 28, 2025
• Study Completion: May 1, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

US (1)