Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness (STELO-GLOW)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gestational Diabetes; Postpartum
• Intervention / Treatment: Device: Dexcom Stelo real-time Continuous Glucose Monitor

Detailed Description

50 postpartum individuals with GDM during their most recent pregnancy will be enrolled in this prospective observational study. In a prior study looking at real-world use of Dexcom G7 CGM during pregnancy among people with GDM, feasibility was demonstrated as well as a willingness to continue CGM use during the postpartum period.

Each enrolled subject will be asked to train and wear the Dexcom Stelo glucose biosensor system continuously for the first 6 weeks after delivery and at least 1 sensor wear every 3 months (up to 15 days at 3, 6, 9, and 12 months) for the remainder of the postpartum period up to 1 year from delivery. The first insertion will be performed under trained observation and additional supplies will be provided every 3 months. Participants will be trained and instructed to enter meals, activity, lactation, and anti-diabetic medications (if applicable) in the Dexcom Stelo App as they are willing to input. Subjects will be provided education on the importance of nutrition, physical activity, and mental health in postpartum and long-term health and tips on how to use CGM data to encourage lifestyle and behavioral modifications.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Christian Huertas Pagan; Phone Number: 503-418-1231; Email: mfmresearch@ohsu.edu

Study Locations

• United States
  • California
    • Santa Barbara, California, United States, 93105
      • Sansum Diabetes Research Institute
      • Principal Investigator: Kristin Castorino, DO
      • Contact: Alex AlChwikani, Recruitment Specialist; Phone Number: 805-682-7640; Email: Aalchwikani@sansum.org
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
      • Contact: Christian Huertas Pagan; Phone Number: 503-418-1231; Email: mfmresearch@ohsu.edu
      • Principal Investigator: Amy M Valent, DO, MCR
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
      • Principal Investigator: Celeste Durnwald, MD
      • Contact: Elizabeth Norton; Phone Number: 267-438-2709; Email: elizabeth.norton@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Postpartum individuals with pregnancies complicated by GDM.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Postpartum Stelo Users; Postpartum individuals with their most recent pregnancy complicated by Gestational Diabetes Mellitus (GDM)

Device: Dexcom Stelo real-time Continuous Glucose Monitor; The Stelo Glucose Biosensor is an over-the-counter integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. Participants will use Stelo for the 6 weeks following delivery and for 15 days at 3 months, 6 months, 9 months, and 1 year postpartum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Glucose	24-hour mean glucose based on Stelo Glucose Biosensor readings	Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.
Glucose Percent Time in Range	Percent time-in-range (percent of the time between 70-140 mg/dL or 70-120 mg/dL) based on Stelo Glucose Biosensor readings	Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.
Glucose Percent Time Above Range	Percent time-above-range (percent of the time above 140 mg/dL or 120 mg/dL) based on Stelo Glucose Biosensor readings	Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.
Postpartum Fasting Glucose	Postpartum fasting glucose as determined by a blood test	Measured at 6 and 12 months postpartum
Postpartum A1C	Postpartum Hemoglobin A1C as determined by a blood test	Measured at 6 and 12 months postpartum

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of Pennsylvania; DexCom, Inc.; Sansum Diabetes Research Institute
• Investigators: Principal Investigator: Celeste Durnwald, MD, University of Pennsylvania; Principal Investigator: Kristin Castorino, DO, Sansum Diabetes Research Institute; Principal Investigator: Amy M Valent, DO, MCR, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Postpartum Glucose Management
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational
• Other Study ID Numbers: STUDY00028947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be available upon request following publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No