Using continuous glucose monitors during pregnancy for women with type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of continuous glucose monitoring (CGM) versus standard fingerstick glucose monitoring in 180 pregnant women with type 2 diabetes mellitus (T2DM). The randomized controlled trial will assess the impact of CGM on maternal glycemic control, patient satisfaction, and adverse perinatal outcomes, particularly focusing on the incidence of large for gestational age infants. The study addresses a gap in research regarding CGM use in this population, which has been minimally studied despite its potential benefits. By providing detailed insights into glucose fluctuations, CGM may improve outcomes for both mothers and infants.

Why it matters

Who can join: the full rules

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 it's running

• University of Massachusetts Memorial Medical Center
  Worcester, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Gianna L Wilkie, MD — University of Massachusetts, Worcester
• Study coordinator: Gianna L Wilkie, MD
• Email: Gianna.Wilkie@umassmemorial.org
• Phone: 7743642523

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• NOURISH: a community partnership to improve nutrition and glycemic control in pregnant women with pregestational diabetes

  Aiming to test a healthcare-community program that delivers healthy food weekly and provides nutrition education to pregnant women with type 1 or type 2 diabetes who have food insecurity, to improve blood sugar and pregnancy outcomes.

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• MOCHA: Inpatient Mental Health Care for High-Risk Pregnancy

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• Permissive versus strict blood sugar control during labor for pregnant people with type 1 diabetes

  This trial will test whether allowing slightly higher blood sugars (70–140 mg/dL) during labor is as safe for newborns as keeping tighter control (70–110 mg/dL) for pregnant people with type 1 diabetes using hybrid closed‑loop insulin systems.

  Recruiting Phase 4 Ohio State University · Columbus, Ohio · NCT07293715

• Impact of Automated Insulin Delivery on Pregnancy Outcomes

  This study looks at how using automated insulin delivery systems during pregnancy affects the health of both mothers with type 1 diabetes and their babies.

  Recruiting University of California, San Francisco · San Francisco, California · NCT06654713

• Closed-loop insulin delivery for adults with type 2 diabetes

  This study is testing a new closed-loop insulin delivery system to see if it helps adults with type 2 diabetes manage their blood sugar better than their usual insulin therapy.

  Recruiting at 5 sites University of Cambridge · Melbourne and 11 other locations · NCT06579404

• Comparing Metformin and Insulin for Gestational Diabetes Treatment

  This study is testing whether metformin is as effective as insulin for treating gestational diabetes in pregnant people and looks at how safe both treatments are for mothers and their babies.

  Recruiting at 22 sites Phase 4 Ohio State University · Tuscaloosa, Alabama and 25 other locations · NCT06445946

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.