Diabetes Mellitus
Conditions
Brief summary
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
Interventions
DEVICEDexcom CGM System
Dexcom CGM System
Sponsors
DexCom, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Confirmed pregnancy * Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM) * Willing to wear up to the required number of Systems for the total duration of study wear * Able to follow study procedures; * Able to speak, read, and write in English or Spanish.
Exclusion criteria
* Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites * Known allergy to medical-grade adhesives * Hematocrit outside specification * Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy * Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period * Currently using Hydroxyurea for treatment * Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dexcom Continuous Glucose Monitoring (CGM) System Performance | 10 Days | The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) comparator venous plasma measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Related Adverse Device Effects | 10 Days | The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants |
Countries
United States
Contacts
Primary ContactStayce Beck, PhD, MPH
Backup ContactNelly Njeru
Outcome results
None listed