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

February 17, 2022 updated by: DexCom, Inc.
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Sansum Diabetes Research Institute
        • Principal Investigator:
          • Kristin Castorino, D.O.
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Barbara Davis Center for Childhood Diabetes
        • Contact:
        • Principal Investigator:
          • Sarit Polsky, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Principal Investigator:
          • Carol Levy, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Amy Valent, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

  1. Age ≥ 18 years
  2. Confirmed pregnancy
  3. Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dexcom CGM System
Device: Dexcom CGM System
Dexcom CGM System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dexcom Continuous Glucose Monitoring (CGM) System Performance
Time Frame: 10 Days
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) comparator venous plasma measurements
10 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Related Adverse Device Effects
Time Frame: 10 Days
The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants
10 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DexCom, Inc.

Investigators

  • Principal Investigator: Florence Brown, MD, Joslin Diabetes Center
  • Principal Investigator: Carol Levy, MD, CDCES, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Sarit Polsky,, MD, MPH, Barbara Davis Center
  • Principal Investigator: Amy Valent, DO, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Anticipated)

March 31, 2022

Study Completion (Anticipated)

April 15, 2022

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTL-904284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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