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Not yet recruiting NCT07356986

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

— Observational Gestational Diabetes Postpartum

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexcom Stelo real-time Continuous Glucose Monitor.
Who it may be relevant to
Registry conditions: Gestational Diabetes, Postpartum. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Mean Glucose [Time frame: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.]
  • 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.]
  • 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.]
  • Postpartum Fasting Glucose [Time frame: Measured at 6 and 12 months postpartum]
  • Postpartum A1C [Time frame: Measured at 6 and 12 months postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 3 centers
  • Sansum Diabetes Research Institute — Santa Barbara
  • Oregon Health & Science University — Portland
  • University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT07356986 · STUDY00028947

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗