Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Dexcom

Status: Unknown

Conditions: Diabetes Mellitus

Treatments: Device: Dexcom CGM System

Study type: Observational

Funder types: Industry

Identifiers

NCT04905628

PTL-904284

Details and patient eligibility

About

Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Dexcom CGM System

Description:

Dexcom CGM System

Treatment:

Device: Dexcom CGM System