NCT07184775 CGM Adherence Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes
| NCT ID | NCT07184775 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Thomas Jefferson University |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-03-01 |
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 70 participants in total. It began in 2025-10-01 with a primary completion date of 2026-03-01.
⚠ 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 compare patient adherence to blood sugar monitoring during pregnancy using two different measurement methods in pregnancies complicated by pregestational type 2 diabetes (T2DM). Pregnant patients with T2DM are at risk of having larger babies, babies with low sugar levels in the first 24 hours of life, higher rates of cesarean delivery, stillbirth (death of baby inside the womb), and hypertensive or high blood pressure disorders of pregnancy, such as preeclampsia. Prior studies have shown that treating high blood sugars in pregnancy with medications can reduce these risks. To determine the amount of medication needed, recording of blood sugar levels is necessary. This trial aims to determine whether continuous blood sugar monitors have improved patient recording of blood sugar levels over finger stick blood sugar measurements. Patients involved in the study will be assigned to either: 1. Fingerstick glucose monitoring (FSG) 2. Continuous glucose monitoring (CGM) Patients will be randomize in a 1:1 ratio. FSG Group: blood sugar is tested four times daily - once fasting and two hours after every meal (post-prandial). Blood will be tested using a glucometer, and values will be recorded in a blood sugar log from the time of enrollment to the time of delivery. CGM Group: A CGM sensor will be placed on the patient's arm for blood sugar collection every 3-5 minutes. This data is sent to a phone application from the time of enrollment to the time of delivery. These sensors will need to be replaced every 14 days. Percent adherence will be recorded from the time you were randomized to a study group until delivery.
Eligibility Criteria
Inclusion Criteria: * singleton pregnancies * fetuses without anomalies * diagnosis of Type 2 diabetes * initiation of prenatal care at \<20 weeks gestation Exclusion Criteria: * diagnosis of Type 1 diabetes * allergy to insulin * inability to wear a continuous glucose monitor
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07184775 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07184775 currently recruiting?
Yes, NCT07184775 is actively recruiting participants. Contact the research team at brandy.firman@jefferson.edu for enrollment information.
Where is the NCT07184775 trial being conducted?
This trial is being conducted at Sewell, United States, Philadelphia, United States.
Who is sponsoring the NCT07184775 clinical trial?
NCT07184775 is sponsored by Thomas Jefferson University. The trial plans to enroll 70 participants.
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