Gestational Diabetes, Postpartum
Conditions
Keywords
Continuous Glucose Monitoring, Postpartum Glucose Management
Brief 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 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
DEVICEDexcom 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.
Sponsors
Oregon Health and Science University
DexCom, Inc.
University of Pennsylvania
Sansum Diabetes Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Glucose | 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 | 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 | 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 | Measured at 6 and 12 months postpartum | Postpartum fasting glucose as determined by a blood test |
| Postpartum A1C | Measured at 6 and 12 months postpartum | Postpartum Hemoglobin A1C as determined by a blood test |
Countries
United States
Contacts
CONTACTChristian Huertas Pagan
PRINCIPAL_INVESTIGATORAmy M Valent, DO, MCR
Oregon Health and Science University
PRINCIPAL_INVESTIGATORCeleste Durnwald, MD
University of Pennsylvania
PRINCIPAL_INVESTIGATORKristin Castorino, DO
Sansum Diabetes Research Institute
Outcome results
None listed