NCT05317585 Continuous Glucose Monitor Use in Pregnancy
| NCT ID | NCT05317585 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Massachusetts, Worcester |
| Condition | Type 2 Diabetes Treated With Insulin |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-05-23 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-05-23 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Gianna L Wilkie, MD
PRINCIPAL INVESTIGATOR
University of Massachusetts, Worcester
Frequently Asked Questions
Who can join the NCT05317585 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Type 2 Diabetes Treated With Insulin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05317585 currently recruiting?
Yes, NCT05317585 is actively recruiting participants. Contact the research team at Gianna.Wilkie@umassmemorial.org for enrollment information.
Where is the NCT05317585 trial being conducted?
This trial is being conducted at Worcester, United States.
Who is sponsoring the NCT05317585 clinical trial?
NCT05317585 is sponsored by University of Massachusetts, Worcester. The principal investigator is Gianna L Wilkie, MD at University of Massachusetts, Worcester. The trial plans to enroll 180 participants.
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