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Continuous Glucose Monitor Use in Pregnancy

Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares a continuous glucose monitor, which tracks blood sugar throughout the day, with several daily fingerstick checks. It is for 180 pregnant women with type 2 diabetes. Researchers will look at blood sugar control, babies who grow larger than expected, patient satisfaction, and other health problems around birth.

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old.
  • You are pregnant with one baby and are no more than 14 weeks pregnant at your first pregnancy care visit.
  • You have type 2 diabetes confirmed by at least one blood test: A1c of 6.5% or higher, an oral glucose tolerance test result of 200 mg/dL or higher, or fasting blood sugar of 126 mg/dL or higher.
  • You get pregnancy care at UMASS Memorial Health Care (UMMHC) and plan to give birth there.
  • You can and are willing to give informed consent, which means you understand the study and agree to join.

Who can't join

  • You have type 1 diabetes or gestational diabetes, which is diabetes that develops during pregnancy.
  • You plan to get pregnancy care or give birth outside UMMHC.
  • You cannot give informed consent to join the study.
  • You are pregnant with more than one baby.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria: * 1\) age greater than or equal to 18 years old * 2\) singleton gestation less than or equal to 14 weeks at initial obstetric visit * 3\) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL * 4\) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC * 5\) able and willing to provide informed consent Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria: * 1\) known diagnosis of type 1 diabetes or gestational diabetes * 2\) plan to receive prenatal care or delivery outside of UMMHC * 3\) inability to provide informed consent * 4\) multifetal gestation

Study sites (1)

MA