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NCT Number: NCT07356986

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sansum Diabetes Research Institute, Santa Barbara, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom Stelo real-time Continuous Glucose Monitor

Device

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.

Primary outcomes

  1. Mean Glucose

    Time frame: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.

    24-hour mean glucose based on Stelo Glucose Biosensor readings

  2. Glucose Percent Time in Range

    Time frame: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.

    Percent time-in-range (percent of the time between 70-140 mg/dL or 70-120 mg/dL) based on Stelo Glucose Biosensor readings

  3. Glucose Percent Time Above Range

    Time frame: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.

    Percent time-above-range (percent of the time above 140 mg/dL or 120 mg/dL) based on Stelo Glucose Biosensor readings

  4. Postpartum Fasting Glucose

    Time frame: Measured at 6 and 12 months postpartum

    Postpartum fasting glucose as determined by a blood test

  5. Postpartum A1C

    Time frame: Measured at 6 and 12 months postpartum

    Postpartum Hemoglobin A1C as determined by a blood test

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Huertas Pagan

CONTACT

[email protected]

503-418-1231

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • DexCom, Inc.
  • Sansum Diabetes Research Institute
  • University of Pennsylvania

Registry information

Acronym: STELO-GLOW

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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