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

Oregon Health & Science University (OHSU)

Status: Not yet enrolling

Conditions: Gestational Diabetes; Postpartum

Treatments: Device: Dexcom Stelo real-time Continuous Glucose Monitor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07356986

STUDY00028947

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Postpartum Stelo Users

Description:

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

Treatment:

Device: Dexcom Stelo real-time Continuous Glucose Monitor