Recruiting

CGM

Sponsor:

DexCom, Inc.

Code:

NCT04905628

Conditions

Diabetes Mellitus

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexcom CGM System

Study Details

Brief summary:

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

Conditions

Diabetes Mellitus

Study ID

NCT04905628

Start date

Jul 8, 2021

Status verified date

Feb, 2022

Completion date

Apr 15, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Dexcom CGM System

Dexcom CGM System

Interventions

Dexcom CGM System

Dexcom CGM System

Primary outcome measure

  • Dexcom Continuous Glucose Monitoring (CGM) System Performance [ Time Frame: 10 Days ]

Central Contacts and Locations

Central contacts

Stayce Beck, PhD, MPH

858-203-6454PTL904284@dexcom.com

Nelly Njeru

858-203-6379PTL904284@dexcom.com

Locations

Sansum Diabetes Research Institute

Recruiting

Santa Barbara, California, United States, 93105

Contacts

Nina Shelton

nshelton@sansum.org

Principal Investigator:

Kristin Castorino, D.O.

Barbara Davis Center for Childhood Diabetes

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Christie Beatson, RD, CDE

CHRISTIE.BEATSON@CUANSCHUTZ.EDU

Principal Investigator:

Sarit Polsky, MD

Joslin Diabetes Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Julianne O'Connell

julianne.oconnell@joslin.harvard.edu

Principal Investigator:

Florence Brown, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Selassie Ogyaadu

selassie.ogyaadu@mssm.edu

Principal Investigator:

Carol Levy, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Monica Rincon

mfmresearch@ohsu.edu

Principal Investigator:

Amy Valent, MD

More Information

Sponsor

DexCom, Inc.

Last update posted

Feb 21, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by DexCom, Inc. on 2022-02-21.