Gestational Diabetes Clinical Trials

The primary objective of the STRIVE study is to compare two implementation strategies for Diabetes Prevention Program delivery: an in-person health coach strategy (standard 24 in-person sessions at WIC clinics) vs. a multifaceted technology-assisted health coach implementation strategy (12 in-person sessions at WIC clinics supplemented by technology support) on implementation and health-related outcomes in postpartum women. Read Less

The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications. Read Less

GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM. Read Less

This is a randomized controlled trial to assess the effect of routine exercise counseling compared to the recommendation for postprandial ambulation on infant birthweight among pregnant people with gestational diabetes mellitus. The primary outcome is birthweight percentile for gestational age at delivery. Secondary outcomes include feasibility and acceptability, need for metformin or insulin for glycemic control, mode of delivery, neonatal hypoglycemia. Participants will be counseled to either complete 20 minutes of walking after meals, or be counseled with routine exercise counseling of 30 minutes of low-impact 5x a week. Their activity will be tracked by "FitBit" pedometers and uploaded via bluetooth to a database for review. They will continue to receive routine obstetric and diabetes care. Read Less

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? Read Less

Gestational diabetes mellitus (GDM), characterized by maternal high blood sugar, affects up to 15% of pregnancies worldwide. GDM doubles the risk of fetal growth (i.e. macrosomia, large fetus,) which further predisposes the affected fetus to elevated risks of obesity, diabetes and cardiovascular disease later in life. The placenta mediates macrosomia by increasing fat and glucose transport to the fetus during GDM. Effective methods to normalize placental nutrient transport and prevent macrosomia are lacking. Choline is a semi-essential nutrient found in egg yolks, meat, fish and cruciferous vegetables. The demand for this nutrient increases substantially during pregnancy. Previous research demonstrated that maternal choline supplementation (MCS) normalized placental fat and glucose transport as well as fetal growth and fat mass in GDM mice. In this study, the investigators will recruit pregnant women with GDM and randomized them to receive a choline supplement (470mg/day, a dose with demonstrated safety), or a placebo for 8 weeks, starting after gestational week 28. The investigators will determine the effects of choline on fetal growth as well as the influence of choline on placental transport and epigenetic modifications in growth-related genes in the placenta and umbilical cord. Successful completion of this study will provide valuable insights into the use of choline supplement as a modifier of placental macronutrient homeostasis in GDM to improve fetal growth outcomes. Read Less

This is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. Mothers are asked to provide 2 blood samples, undergo fingerstick blood measurements, and to have their newborns measured for body fat composition in the first 6 months of life. Read Less

The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use. Read Less

The aim of this study is to evaluate the impact of personalized postpartum follow-up cards on completion of postpartum health related tasks. The intervention will consist of a card given to patients at time of discharge. One side of the card will list the patient's name and a list of recommended postpartum follow-up appointments based on their diagnoses at the time of discharge. Participants will be randomized to this intervention or the control group, which will consist of standard education routinely given at discharge. The primary endpoint will be the rate of completion of a postpartum blood pressure check or two hour glucose tolerance test, or both, depending on the patient's discharge diagnosis within the first year after discharge. The secondary endpoints will include establishing care with a primary care provider within the first year after delivery, or completion of postpartum pap smear or colposcopy, as indicated. Read Less

The purpose of this investigation is to examine NADPH oxidase as a source of reactive oxygen species contributing to aberrant microvascular function in otherwise healthy women with a history of GDM. Read Less

The purpose of this study is to examine whether RT-CGM (real time continuous glucose monitoring) use improves glucose control, maternal outcomes, and fetal outcomes in patients diagnosed with gestational diabetes. Currently, there is very limited data on whether RT-CGM use helps patients diagnosed with gestational diabetes. By conducting this study, the investigator hopes to develop a deeper understanding of how use of a RT-CGM may affect glucose control in the gestational diabetes population. Read Less

The hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Investigators will determine GDM subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. Participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals. Read Less