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

Sponsor
DexCom, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04905628
Collaborator
(none)
100
Enrollment
5
Locations
9.2
Anticipated Duration (Months)
20
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Dexcom CGM System

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
Actual Study Start Date :
Jul 8, 2021
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Apr 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Dexcom CGM System

Dexcom CGM System

Device: Dexcom CGM System
Dexcom CGM System

Outcome Measures

Primary Outcome Measures

  1. Dexcom Continuous Glucose Monitoring (CGM) System Performance [10 Days]

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

Secondary Outcome Measures

  1. System Related Adverse Device Effects [10 Days]

    The Dexcom Continuous Glucose Monitoring (CGM) System will be characterized by Adverse Device Effects experienced by study participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sansum Diabetes Research Institute Santa Barbara California United States 93105
2 Barbara Davis Center for Childhood Diabetes Aurora Colorado United States 80045
3 Joslin Diabetes Center Boston Massachusetts United States 02215
4 Icahn School of Medicine at Mount Sinai New York New York United States 10029
5 Oregon Health & Science University Portland Oregon United States 97239

Sponsors and Collaborators

  • DexCom, Inc.

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT04905628
Other Study ID Numbers:
  • PTL-904284
First Posted:
May 27, 2021
Last Update Posted:
Feb 21, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Diabetes Mellitus

Study Results

No Results Posted as of Feb 21, 2022