Gestational DiabetesSTELO-GLOWNCT07356986
Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness
An observational study of Gestational Diabetes and Postpartum, run by Oregon Health and Science University at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Postpartum
- What is being tested?
- Dexcom Stelo real-time Continuous Glucose Monitor
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postpartum individuals with pregnancies complicated by GDM.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Elizabeth Norton, 267-438-2709, elizabeth.norton@pennmedicine.upenn.edu
Celeste Durnwald, MD
Oregon Health & Science University
Portland, Oregon, 97239
Christian Huertas Pagan, 503-418-1231, mfmresearch@ohsu.edu
Amy M Valent, DO, MCR
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Alex AlChwikani, Recruitment Specialist, 805-682-7640, Aalchwikani@sansum.org
Kristin Castorino, DO
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes, Postpartum
- Being tested
- Dexcom Stelo real-time Continuous Glucose Monitor
- Keywords
- Continuous Glucose Monitoring, Postpartum Glucose Management
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom Stelo real-time Continuous Glucose MonitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum Stelo Users | Postpartum individuals with their most recent pregnancy complicated by Gestational Diabetes Mellitus (GDM) Receives: Device: Dexcom Stelo real-time Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Glucose
24-hour mean glucose based on Stelo Glucose Biosensor readings
Measured: 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: 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: 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: Measured at 6 and 12 months postpartum
Postpartum A1C
Postpartum Hemoglobin A1C as determined by a blood test
Measured: Measured at 6 and 12 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc., University of Pennsylvania, Sansum Diabetes Research Institute
- Responsible party
- Principal investigator, Amy Miyoshi Valent, Oregon Health and Science University
- Investigators
- Amy M Valent, DO, MCR, Principal investigator, Oregon Health and Science UniversityCeleste Durnwald, MD, Principal investigator, University of PennsylvaniaKristin Castorino, DO, Principal investigator, Sansum Diabetes Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356986
- Sponsor's protocol ID
- STUDY00028947
- Acronym
- STELO-GLOW
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available upon request following publication.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness
- ClinicalTrials.gov ID
- NCT07356986
- Acronym / sponsor ID
- STELO-GLOW / STUDY00028947
- Conditions
- Gestational Diabetes, Postpartum
- Keywords
- Continuous Glucose Monitoring, Postpartum Glucose Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- DexCom, Inc., University of Pennsylvania, Sansum Diabetes Research Institute
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum Stelo Users | – | Device: Dexcom Stelo real-time Continuous Glucose MonitorPostpartum individuals with their most recent pregnancy complicated by Gestational Diabetes Mellitus (GDM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postpartum individuals with pregnancies complicated by GDM.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom Stelo real-time Continuous Glucose MonitorThe 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. | Device | Postpartum Stelo Users |
Primary outcome
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
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
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
Postpartum Fasting Glucose
Time frame: Measured at 6 and 12 months postpartum
Postpartum fasting glucose as determined by a blood test
Postpartum A1C
Time frame: Measured at 6 and 12 months postpartum
Postpartum Hemoglobin A1C as determined by a blood test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be available upon request following publication.
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy M Valent, DO, MCR principal investigator
Oregon Health and Science University
Celeste Durnwald, MD principal investigator
University of Pennsylvania
Kristin Castorino, DO principal investigator
Sansum Diabetes Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Postpartum, run by Oregon Health and Science University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Huertas Pagan (503-418-1231, mfmresearch@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Glucose (time frame: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.