NCT05317585 · University of Massachusetts, Worcester
Continuous Glucose Monitor Use in Pregnancy
What this study is about
The purpose of this study is to perform a randomly assigned controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the the usual treatment 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Worcester, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 1, 2025 · Source of record for eligibility and locations