Using continuous glucose monitors during pregnancy for women with type 2 diabetes
Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
NA · University of Massachusetts, Worcester · NCT05317585
This study is testing if using continuous glucose monitors during pregnancy can help women with type 2 diabetes manage their blood sugar better and have healthier babies compared to the usual fingerstick method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Massachusetts, Worcester (other) |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT05317585 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older with a diagnosis of type 2 diabetes and a singleton gestation of 14 weeks or less.
Not a fit: Patients with type 1 diabetes, gestational diabetes, multifetal gestation, or those planning to receive care outside of the study location may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and reduced adverse outcomes for pregnant women with type 2 diabetes.
How similar studies have performed: Preliminary studies have shown improvement in outcomes for pregnant women with type 1 diabetes using CGM, suggesting potential success for this approach in women with type 2 diabetes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Worcester, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes Treated With Insulin, Pregnancy, High Risk, Type 2 diabetes, Pregnancy