Dexcom Stelo CGM Use Postpartum for Women with Gestational Diabetes

This observational study is looking at how women who had gestational diabetes (diabetes during pregnancy) use the Dexcom Stelo real-time Continuous Glucose Monitor (CGM) after giving birth. The Dexcom Stelo is an over-the-counter device that continuously measures your glucose (sugar) levels. Researchers want to understand how this device is used in real life and if it helps women manage their health long-term. You may be able to join if you are a woman aged 18 or older who was recently diagnosed with gestational diabetes and has a smartphone compatible with the Dexcom Stelo app. The study will measure your average glucose, how much time your glucose is in a healthy range, and how much time it's above that range.

Study design
This is an observational study with 50 participants. It is not specified if it is blinded or randomized.
What's involved
You will wear the Dexcom Stelo glucose biosensor continuously for the first 6 weeks after delivery, and then for at least 15 days at 3, 6, 9, and 12 months postpartum. You will also be asked to enter meals, activity, lactation, and medications into the Dexcom Stelo app.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 1 year from delivery, with glucose measurements taken at 3, 6, 9, and 12 months postpartum.

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NCT07356986

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

Not Yet Recruiting
Not specifiedAges 18+Observational
Oregon Health and Science University
~50 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:Dexcom Stelo real-time Continuous Glucose Monitor

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean Glucose
Measured over Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.
+4 more outcomes measured
Gestational Diabetes
Postpartum
3 sites across 3 states
California1
Oregon1
Pennsylvania1
  • 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

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Eligibility criteria

Inclusion

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

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
  • Mean GlucoseMeasured 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 RangeMeasured 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 RangeMeasured 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 GlucoseMeasured at 6 and 12 months postpartum

    Postpartum fasting glucose as determined by a blood test

  • Postpartum A1CMeasured at 6 and 12 months postpartum

    Postpartum Hemoglobin A1C as determined by a blood test