Effectiveness of CGMS Vs. Self-monitoring Blood Glucose (SMBG) in Woman with Gestational Diabetes

Completed · Not applicable

Conditions studied: Gestational Diabetes Mellitus in Pregnancy

In brief

The detection of and control of gestational diabetes carries benefits for both mother and baby related to immediate pregnancy outcomes. The glycemic disorders in diabetes are not solely limited to fasting and postprandial hyperglycemia, but can be extended to the glycemic variability that includes both upward (postprandial glucose increments) and downward (interprandial glucose decrements) changes. Glycemic variability, as a component of the glycemic disorders, has more deleterious effects than sustained chronic hyperglycemia in the development of diabetic complications. Glycemic variability is associated with increased risks of adverse pregnancy outcomes in GDM. Hyperglycemic excursion has been shown to be the strongest predictor of macrosomia, the most common complication of pregnancy with diabetes. When compared with routine standard antenatal care, continuous glucose monitoring system (CGMS) guided treatments should significantly improve glycemic control, lower infant birth weight, and reduce risk of macrosomia in gestational women with diabetes. We will investigate the following questions (1) Whether CGMS can detect greater glycemic variability in women with an early GDM diagnosis; (2) Whether CGMS can subsequently moderate treatment strategies of GDM especially patient behavior and glucose levels; (3) Whether CGMS can eventually improve maternal (i.e., reduce gestational weight gain and lower glycemic levels during pregnancy) and fetal outcomes (reduce LGA babies and C-section rate) compared with traditional self-monitored blood glucose (SMBG) use.

Key facts

Study ID

NCT04948112

Run by

Woman's

People needed

128

Starts

2021-10-01

Expected to finish

2024-06-30

Last updated by the study team

2024-10-18

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• • 8-26 weeks gestation
• singleton pregnancy,
• a positive oral glucose tolerance test
• written informed consent.

You may not qualify if…

• • prior diagnosis of diabetes mellitus,
• presence of infection,
• Presence of significant systemic disease or other severe metabolic, endocrine, medical co-morbidities
• history of bariatric surgery or other surgeries that induce malabsorption
• long-term use (>2 weeks) of systemic steroids prior to enrolment
• multiple pregnancy
• patients already using glucose lowering medications (metformin or insulin) before study entry
• fetal growth restriction due to placental dysfunction at study entry
• History of major depressive or other severe psychiatric disorders or inpatient psychiatric treatment up to 1year before enrolment
• Inability or refusal to comply with protocol
• Currently participating or having participated in an experimental study in previous three months

Where it is running

• Karen Elkind-Hirsch — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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