Clinical trial NCT06457139: Preventing T2DM After GDM With Immediate Postpartum Screening
Official title: Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Type 2 Diabetes
Keywords: diabetes
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening for postpartum patients with pregnancies affected by GDM.

Detailed description: Gestational diabetes mellitus (GDM) affects 6 to 8% of U.S. pregnancies annually and upwards of 1 in every 8 pregnancies worldwide. Pregnant individuals with GDM have higher rates of hypertensive disorders of pregnancy, cesarean delivery, and maternal mortality as compared to those without GDM. While GDM frequently resolves after delivery, up to 70% of patients will develop type 2 diabetes mellitus (T2DM) later in life10 and one third will develop subsequent diabetes or impaired glucose metabolism at the time of postpartum screening.

While postpartum screening is recommended by the American College of Obstetricians and Gynecologists (ACOG) and the American Diabetes Association (ADA) between 4-12 weeks postpartum for all patients with GDM in pregnancy, nearly 40% of patients do not attend a postpartum visit. Attendance is even lower among populations with limited resources, contributing to health disparities.

To address this issue, immediate in-hospital postpartum glucose tolerance testing has been evaluated and found to yield diagnostic values comparable to postpartum screening with the advantage of \~100% adherence. However, 2 challenges remain: currently there is a lack of widespread clinical implementation of in-hospital immediate postpartum diabetes screening.

Therefore, the overall goal of this proposal is to randomize patients to early screening during their postpartum hospitalization versus at their 6 week postpartum visit (current standard of care).

Eligibility criteria: Inclusion Criteria:

* pregnancy complicated by GDM as diagnosed with traditional two step testing in the third trimester according to Carpenter-Coustan Criteria
* receiving prenatal care at UMASS Memorial and plans to deliver at UMASS Memorial
* able and willing to provide informed consent
* ability to complete immediate in hospital postpartum glucose testing
* have evidence of impaired glucose metabolism defined as fasting glucose value of ≥126 mg/dL or 2-hour glucose value of ≥200 mg/dL

Exclusion Criteria:

* known diagnosis of pre-existing pre-gestational diabetes in pregnancy
* inability to complete oral glucose tolerance test (e.g. gastric bypass surgery history, gastric dumping syndrome history, vomiting of oral glucose tolerance test) in pregnancy or immediately postpartum
* systemic steroid use

Primary outcomes:
measure: Detection of Type 2 Diabetes Mellitus
timeFrame: At time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
measure: Glycemic Outcomes--Hemoglobin A1c
timeFrame: at time of postpartum screening (postpartum day 1 or 6 week postpartum visit pending randomization arm)
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: At postpartum visit (6 weeks after delivery)
measure: Patient Recruitment
timeFrame: at time of randomization (postpartum day 1)
measure: Patient Retention
timeFrame: At postpartum visit (6 weeks after delivery)
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMASS Memorial Healthcare
name: Gianna Wilkie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waters TP, Kim SY, Werner E, Dinglas C, Carter EB, Patel R, Sharma AJ, Catalano P. Should women with gestational diabetes be screened at delivery hospitalization for type 2 diabetes? Am J Obstet Gynecol. 2020 Jan;222(1):73.e1-73.e11. doi: 10.1016/j.ajog.2019.07.035. Epub 2019 Jul 24.
citation: Dinglas C, Muscat J, Heo H, Islam S, Vintzileos A. Immediate Postpartum Glucose Tolerance Testing in Women with Gestational Diabetes: A Pilot Study. Am J Perinatol. 2017 Oct;34(12):1264-1270. doi: 10.1055/s-0037-1606620. Epub 2017 Sep 14. No abstract available.
citation: Ratner RE, Christophi CA, Metzger BE, Dabelea D, Bennett PH, Pi-Sunyer X, Fowler S, Kahn SE; Diabetes Prevention Program Research Group. Prevention of diabetes in women with a history of gestational diabetes: effects of metformin and lifestyle interventions. J Clin Endocrinol Metab. 2008 Dec;93(12):4774-9. doi: 10.1210/jc.2008-0772. Epub 2008 Sep 30.
citation: Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.
citation: Werner EF, Has P, Rouse D, Clark MA. Two-day postpartum compared with 4- to 12-week postpartum glucose tolerance testing for women with gestational diabetes. Am J Obstet Gynecol. 2020 Sep;223(3):439.e1-439.e7. doi: 10.1016/j.ajog.2020.05.036. Epub 2020 May 26.