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

NCT07184775 | Recruiting FDA Device

• 1 other identifier: iRISID-2024-1410
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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. 1.Fingerstick glucose monitoring (FSG)
2. 2.Continuous glucose monitoring (CGM)

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient glucose monitoring adherence

  Compare adherence to glucose monitoring using continuous glucose monitoring versus finger stick monitoring in pregnant patients with Type 2 Diabetes

  through pregnancy episode, typically 20-35 weeks

Secondary Outcomes (2)

• Fetal/neonatal outcomes

  through pregnancy episode, typically 20-35 weeks

• Maternal outcomes

  through pregnancy episode, typically 20-35 weeks

Study Arms (2)

Continuous glucose monitoring

ACTIVE COMPARATOR

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.

Device: Continuous glucose monitor

Finger stick blood glucose monitoring

ACTIVE COMPARATOR

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.

Device: Glucometer

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.

Also known as: CGM

Continuous glucose monitoring

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.

Finger stick blood glucose monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• singleton pregnancies
• fetuses without anomalies
• diagnosis of Type 2 diabetes
• initiation of prenatal care at \<20 weeks gestation

You may not qualify if:

• diagnosis of Type 1 diabetes
• allergy to insulin
• inability to wear a continuous glucose monitor

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Sidney Kimmel Cancer Center at Thomas Jefferson University: collaborator

Study Sites (2)

Jefferson Health New Jersey

Sewell, New Jersey, 08080, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (2)

• Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.

  PMID: 18818254 BACKGROUND

• Wernimont SA, Sheng JS, Tymkowicz A, Fleener DK, Summers KM, Syrop CH, Andrews JI. Adherence to self-glucose monitoring recommendations and perinatal outcomes in pregnancies complicated by diabetes mellitus. Am J Obstet Gynecol MFM. 2019 Aug;1(3):100031. doi: 10.1016/j.ajogmf.2019.100031. Epub 2019 Aug 5.

  PMID: 33345801 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Brandy Firman

CONTACT

215-955-8401; brandy.firman@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Maternal-Fetal Medicine, Medical Genetics and Genomics

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)