Continuous Glucose Monitoring (CGM) Substudy of the DECIDE RCT

Launched by OHIO STATE UNIVERSITY · Jul 1, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how Continuous Glucose Monitoring (CGM) can help manage blood sugar levels in pregnant women with gestational diabetes, a condition that can occur during pregnancy. The study is comparing two medications, metformin and insulin, to see which one helps control blood sugar better and if CGM data can predict any complications during pregnancy or identify diabetes after giving birth. A total of 300 women who need medication for their gestational diabetes will be enrolled, and they will wear a CGM device for monitoring at different points during and after their pregnancy.

To be eligible for this trial, women must be at least 18 years old, pregnant with a single baby, and diagnosed with gestational diabetes needing medication. They should also be willing to attend follow-up visits for up to two years and wear the CGM device. However, there are some reasons a woman may not be able to participate, such as having certain health issues or being part of other studies. Participants can expect regular check-ins and support while they use the CGM to track their blood sugar levels throughout their pregnancy and postpartum period.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Singleton gestation. Twin reduction to singleton, either spontaneously or therapeutically, is eligible if it occurred before 14 weeks gestational age.
• • Age \>18 years
• • Gestational age at randomization between 200/7 - 316/7 weeks based on project gestational age.
• • GDM diagnosis between 200/7 - 316/7 weeks based on project gestational age.
• • Requires medication for glucose control defined as ≥30% elevated glucose values (either fasting or postprandial or both) in the week prior to randomization per determination of the provider or documented in the medical record.
• • Patient willingness and ability to attend 2-year follow-up visit.
• • Patient willingness to wear and return a blinded CGM device. It is possible that some enrolled individuals may choose to use a separate CGM device for glucose monitoring as part of clinical care.
• Exclusion Criteria:
• • Renal disease (serum creatinine \>1.3 mg/dL) due to the potential impact of metformin on renal function.
• • Major structural malformation of the fetus.
• • Known fetal aneuploidy based on invasive testing or positive for aneuploidy on cell-free fetal DNA screening.
• • Contraindication to metformin or insulin, including: history of lactic acidosis, intractable nausea and vomiting, prior documented allergy and/or anaphylaxis.
• • Pregestational diabetes documented in the medical record, GDM diagnosis \<20 weeks, or prior A1c\>6.5%
• • Fasting hyperglycemia \>115 mg/dl for ≥50% of fasting glucose values in the past week (due to the high risk of metformin failure with fasting hyperglycemia).
• • Enrolled in a trial that influences primary study outcomes of the parent DECIDE trial (composite neonatal outcome at delivery or childhood body mass index at 2 years).
• • Prenatal care or delivery planned at a location where access to the complete electronic medical record will not be available to research staff.
• • Language barrier (appropriate translation resources unavailable at the site).
• • Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.
• • In addition, individuals who report a prior allergy or sensitivity to CGM will also be excluded.