Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness

Starting soon

Conditions studied: Gestational Diabetes, Postpartum

In brief

The purpose of this prospective observational study is to gather exploratory and practical use data of the Dexcom Stelo Glucose Biosensing System (Stelo), an over-the-counter (OTC) real-time Continuous Glucose Monitoring (CGM) system among patients with Gestational Diabetes Mellitus (GDM) in their most recent pregnancy.

Key facts

Study ID

NCT07356986

Run by

Oregon Health and Science University

People needed

50

Starts

2026-01-01

Expected to finish

2027-12-01

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Gestational Diabetes Mellitus (GDM) diagnosis by 1- or 2-step Oral Glucose Tolerance Test (OGTT) during pregnancy or >= 200 mg following any glucose challenge (50g, 75g, 100g)
• Has a smart phone compatible to support Dexcom Stelo app
• Able to read, write, and understand English
• Meet Stelo Glucose Biosensor Indications for Use (IFU) per approved commercial labeling
• Willing to follow all study procedures

You may not qualify if…

• Greater than 6 weeks and 6 days postpartum at enrollment
• Preexisting Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D)
• End-stage renal failure (on dialysis)
• Heart failure
• Other uncontrolled high-risk condition as determined exclusionary by site investigators
• Extensive skin changes/diseases that preclude wearing the required system on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
• Known severe allergy to medical-grade adhesives
• Any condition that, in the opinion of the investigator, would interfere with their participation in the trial
• Obesity surgery
• Insulin use prior to discharge home from the delivery admission
• Current participation in another postpartum Continuous Glucose Monitoring (CGM) or lifestyle intervention trial

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• Oregon Health & Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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