Gestational Diabetes Clinical Trial
Official title:
Self-Administered 2-Hour Oral Glucose Tolerance Test: A Randomized Controlled Trial
NCT number | NCT06099509 |
Other study ID # | 2097104 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2, 2023 |
Est. completion date | February 2025 |
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?
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 2025 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Prisma Health/Greenville Memorial Hospital | Greenville | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Prisma Health-Upstate |
United States,
"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.
"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.
Blum AK. Insulin Use in Pregnancy: An Update. Diabetes Spectr. 2016 May;29(2):92-7. doi: 10.2337/diaspect.29.2.92. Erratum In: Diabetes Spectr. 2016 Aug;29(3):191. — View Citation
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. — View Citation
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. — View Citation
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/
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient satisfaction | 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.
Telehealth improves my access to healthcare services. Telehealth provides for my healthcare need. Telehealth is an acceptable way to receive healthcare services. I would use telehealth services again. Overall, I am satisfied with this telehealth system. |
within 12 weeks of delivery | |
Primary | 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 |
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