NCT04905628

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 8, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

9 months

First QC Date

May 24, 2021

Last Update Submit

February 17, 2022

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Dexcom Continuous Glucose Monitoring (CGM) System Performance

    The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) comparator venous plasma measurements

    10 Days

Secondary Outcomes (1)

  • System Related Adverse Device Effects

    10 Days

Study Arms (1)

Dexcom CGM System

Dexcom CGM System

Device: Dexcom CGM System

Interventions

Dexcom CGM SystemDEVICE

Dexcom CGM System

Dexcom CGM System

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

RECRUITING

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (1)

  • Polsky S, Valent AM, Isganaitis E, Castorino K, O'Malley G, Beck SE, Gao P, Laffel LM, Brown FM, Levy CJ. Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2024 May;26(5):307-312. doi: 10.1089/dia.2023.0516. Epub 2024 Mar 1.

    PMID: 38315503DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Carol Levy, MD, CDCES

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Sarit Polsky,, MD, MPH

    Barbara Davis Center

    PRINCIPAL INVESTIGATOR

  • Florence Brown, MD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

  • Kristin Castorino, DO

    Sansum Diabetes Research Institute

    PRINCIPAL INVESTIGATOR

  • Amy Valent, DO

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stayce Beck, PhD, MPH

CONTACT

858-203-6454PTL904284@dexcom.com

Nelly Njeru

CONTACT

858-203-6379PTL904284@dexcom.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2021

First Posted

May 27, 2021

Study Start

July 8, 2021

Primary Completion

March 31, 2022

Study Completion

April 15, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)