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

Sponsored by DexCom, Inc.

About this trial

Last updated 3 years ago

Study ID

PTL-904284

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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.

No

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

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Recruiting