Gestational diabetes (GDM) is a significant clinical and public health burden, affecting over 400,000 pregnant women in the United States each year. Without adequate treatment, women with GDM and their infants are at risk for substantial morbidity. Because of this, experts recommend treatment focused on normalization of hyperglycemia to improve outcomes. However, providers have limited capacity to predict which treatment will achieve glycemic goals. This results in a choice based on provider and patient preference and a trial and error approach, which can create delays in glycemic control within the short (8-10 weeks) window between diagnosis and delivery. Maternal and fetal morbidity may be related to a mismatch between glycemic pathophysiology and the mechanism of action of glucose-lowering agents. In fact, GDM is heterogeneous, with predominant insulin resistance (IR) in 50%, insulin secretion deficit (ISD) in 30%, and a combination of both in 20% of women as underlying mechanisms of hyperglycemia. This variation in GDM pathophysiology and clinical outcomes supports the use of an individualized treatment approach. The overall goal of this project is to investigate an individualized treatment approach for GDM where treatment is based on each woman's GDM mechanism. The study will employ the same treatment in both arms, but choice of treatment will differ based on study arm (matched or unmatched to GDM mechanism).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study
Proportion of women who are eligible, screened, enrolled and remain in the study
Time frame: Through study completion, an average of 16 weeks
Proportion of Participants Who Report Suitability of the Study Procedures
Suitability of the study procedures and interventions to participants assessed through one-on-one qualitative interview
Time frame: Through study completion, an average of 16 weeks
Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation
Time frame: 2 weeks after treatment initiation
Proportion of Women Who Remain on Same Treatment During Study
Time frame: Through study completion, an average of 16 weeks
Maternal Glucose Control
\>50% fasting below 95 and 1 hour postprandial \< 140 during the 4 weeks before delivery
Time frame: Delivery
Proportion of Participants Who Deliver by Primary Cesarean
Time frame: Delivery
Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy
Time frame: Delivery
Birthweight
Time frame: Delivery
Neonatal Lean Body Mass
Time frame: Within 72 hours of delivery
Cord Blood Glucose
Time frame: Delivery
Cord Blood C-peptide
Time frame: Delivery
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