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

ID#: NCT04905628

Age: 18 years - 66+

Gender: Female

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: July 08, 2021

End Date: February 01, 2022

Contact Information:
Stayce Beck, PhD, MPH
858-203-6454
Nelly Njeru
858-203-6379
Summary:

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

Eligibility:



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