NCT05317585Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 29 Mar 2022
- Start date
- 23 May 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Massachusetts, Worcester
- Diseases
- Type 2 diabetes
- NCT number
- NCT05317585
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 23 May 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 1\) known diagnosis of type 1 diabetes or gestational diabetes
Other
- 2\) plan to receive prenatal care or delivery outside of UMMHC
- 3\) inability to provide informed consent
- 4\) multifetal gestation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Massachusetts Memorial Medical Center Coordinator of this site? Confirm its status | Worcester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.