Maternal Continuous Glucose Monitoring Surveillance Compared to Finger-stick Glucose Monitoring in Pregnancies With Type 2 Pregestational Diabetes

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• singleton pregnancies

• fetuses without anomalies

• diagnosis of Type 2 diabetes

• initiation of prenatal care at \<20 weeks gestation

Locations
United States
New Jersey
Jefferson Health New Jersey
RECRUITING
Sewell
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Contact Information
Primary
Brandy Firman
brandy.firman@jefferson.edu
215-955-8401
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Collaborators: Sidney Kimmel Cancer Center at Thomas Jefferson University
Leads: Thomas Jefferson University

This content was sourced from clinicaltrials.gov