Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07184775

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

Led by Thomas Jefferson University · Updated on 2025-10-14

70

Participants Needed

2

Research Sites

21 weeks

Total Duration

On this page

Sponsors

T

Thomas Jefferson University

Lead Sponsor

S

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant with a single baby (singleton pregnancy)
  • Baby has no known anomalies
  • Diagnosed with Type 2 diabetes
  • Started prenatal care before 20 weeks of pregnancy
Not Eligible

You will not qualify if you...

  • Diagnosed with Type 1 diabetes
  • Allergic to insulin
  • Unable to wear a continuous glucose monitor device

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Jefferson Health New Jersey

Sewell, New Jersey, United States, 08080

Actively Recruiting

2

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

B

Brandy Firman

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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