Preventing T2DM After GDM With Immediate Postpartum Screening and Treatment

Type 2 Diabetes Clinical Trial

Official title:

Preventing Type 2 Diabetes Mellitus After Gestational Diabetes Mellitus With Immediate Postpartum Screening and Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457139
• Other study ID #: STUDY00001870
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 1, 2025
• Est. completion date: December 1, 2028

Study information

• Verified date: June 2024
• Source: University of Massachusetts, Worcester
• Contact: Gianna Wilkie, MD
• Phone: 508-3444982
• Email: Gianna.Wilkie[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 1) in-hospital immediate postpartum diabetes screening, and 2) treatment with metformin for those patients who screen positive.

To implement early in-hospital screening and treatment, providers require clear guidelines on the optimal management of patients with impaired glucose tolerance. Therefore, the overall goal of this proposal is to create and test an implementation protocol for in-hospital immediate postpartum diabetes screening and subsequent treatment for postpartum patients with pregnancies affected by GDM.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2028
• Est. primary completion date: April 1, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

• English or Spanish speaking

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes
• Type 2 Diabetes

Intervention

Drug:
• Metformin Hydrochloride
metformin extended-release formulation (500 mg tablet administered orally daily with evening meal)

Other:
• Active Comparator
Subjects randomized to the comparison condition will receive the usual standard of care. The standard of care will consist of administration of educational materials adapted from the American Diabetes Association that discusses healthy lifestyle behaviors and the increased risks of developing T2DM after a pregnancy complicated by GDM.

Locations

Country	Name	City	State
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Outcomes--Hemoglobin A1c	Serum blood measurement of hemoglobin A1c	3 months, 6 months and 1 year
Primary	Glycemic Outcomes--Fructosamine Levels	Serum blood measurement of fructosamine levels	3 months, 6 months and 1 year
Secondary	Patient Satisfaction	Participant satisfaction will be assessed using the validated survey, the Patient Satisfaction Survey. The survey was developed in 1979 and has been used to assess patient satisfaction with research participation based on 8 simple questions. It has not been used in a randomized trial in an obstetric population but has been validated in other clinical populations	At randomization, 3, 6, and 12 months after randomization
Secondary	Provider Engagement	The investigators will assess provider comfort with a 5-point Likert scale (not at all comfortable, slightly comfortable, neutral, very comfortable, extremely comfortable) with this screening and treatment strategy, identification of abnormal glucose tolerance, and decisions for treatment with metformin.	At Randomization
Secondary	Patient Recruitment	The investigators will examine the ease and feasibility of recruitment by calculating the total number of subjects that were approached and the reasons for ineligibility and non-participation.	at Randomization/approach
Secondary	Patient Retention	The investigators will record reasons for failure to complete in hospital diabetes screening and treatment.	Randomization, 3, 6, and 12 months after randomization
Secondary	Feasibility of Assessment	The investigators will examine the ease by which patient and providers are able to complete in hospital testing and adhere to early treatment intervention with metformin. Ease of use will be assessed by a 5-point Likert scale (categories: very difficult, somewhat difficult, neutral, somewhat easy, very easy). The investigators will assess medication adherence and experienced side effects for all patients.	At randomization, 3, 6, and 12 months after randomization