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

Last updated: February 17, 2022
Sponsor: DexCom, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT04905628
PTL-904284
  • Ages > 18
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years
  • Confirmed pregnancy
  • Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2Diabetes Mellitus (T2DM)
  • Willing to wear up to the required number of Systems for the total duration of studywear
  • Able to follow study procedures;
  • Able to speak, read, and write in English or Spanish.

Exclusion

Exclusion Criteria:

  • Extensive skin changes/diseases that preclude wearing the required number of Systemsat 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 pregnancycomplications during current pregnancy
  • Currently receiving dialysis treatment or planning to receive dialysis during thesensor wear period
  • Currently using Hydroxyurea for treatment
  • Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, ordiathermy during the sensor wear period

Study Design

Total Participants: 100
Study Start date:
July 08, 2021
Estimated Completion Date:
April 15, 2022

Connect with a study center

  • Sansum Diabetes Research Institute

    Santa Barbara, California 93105
    United States

    Active - Recruiting

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Joslin Diabetes Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.