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New treatment option for Type 2 Diabetes Treated With Insulin
Official title Continuous Glucose Monitor Use in Pregnancy
ClinicalTrials.gov ID: NCT05317585
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Women will be deemed eligible for the study by the following
- 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...
- 4) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
You likely can't join if
- 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
See the full eligibility criteria
- Women will be deemed eligible for the study by the following
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Worcester, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Worcester, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.