CGM Adherence Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes

Part of paid clinical trials in Sewell, New Jersey.

Sponsor
Thomas Jefferson University
Study ID
NCT07184775
Status
Recruiting
Apply to this trial

Conditions

  • Continuous Glucose Monitoring System
  • Pregnancy
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous glucose monitor — DEVICE
    Continuous glucose monitors are sensors that detect interstitial blood glucose measurements and relay values from their sensor to a receiver (typically a cell phone) to document values every 5 minutes.
  • Glucometer — DEVICE
    Glucometer measurement involves a patient performing a finger stick with a lancet to draw blood. They then apply blood to a test strip which is analyzed by a glucometer. The glucose measurement provided by the glucometer is then recorded by the patient in a glucose log.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Sep 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Continuous glucose monitoring
    Patients in this arm of the study will use a continuous glucose monitoring device for glucose monitoring throughout their pregnancy, linked with a HIPAA-compliant digital application that will document measurements.
  • Active Comparator: Finger stick blood glucose monitoring
    Patients randomized to this arm will perform finger stick blood glucose measurements 4x daily (fasting and 2 hours after each meal) and document their measurements in a glucose log.

Primary Outcome Measure

Patient glucose monitoring adherence [ Time Frame: through pregnancy episode, typically 20-35 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Jefferson Health New JerseySewellNew Jersey08080
Brandy Firman
[email protected]
215-955-8401
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Brandy Firman
[email protected]
215--955-8401

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By research site
Jefferson Health New Jersey· Sewell, NJThomas Jefferson University· Philadelphia, PA

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