Recruiting

FSG & CGM

Sponsor:

Thomas Jefferson University

Code:

NCT07184775

Conditions

Type 2 Diabetes Mellitus (T2DM)

Pregnancy

Continuous Glucose Monitoring System

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Continuous glucose monitor

Glucometer

Study Details

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.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Pregnancy

Continuous Glucose Monitoring System

Study ID

NCT07184775

Start date

Oct 1, 2025

Status verified date

Sep, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Continuous glucose monitor

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Jefferson Health New Jersey

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

More Information

Sponsor

Thomas Jefferson University

Last update posted

Oct 14, 2025

Last verified

Sep, 2025

Keywords

  • Type 2 Diabetes
  • Diabetes
  • continuous glucose monitor
  • CGM
  • adherence
  • pregnancy
  • maternal health
  • prenatal care
  • glucose monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-10-14.