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Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Sponsor
DexCom, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04645641
Collaborator
(none)
150
Enrollment
4
Locations
1
Arm
1.6
Anticipated Duration (Months)
37.5
Patients Per Site
22.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

Condition or Disease Intervention/Treatment Phase
  • Device: Continuous Glucose Monitoring System
 N/A

Detailed Description

The objective of the study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Masking Description:
All systems worn will be blinded. Sensor wear locations will be pre-assigned. All sensor insertions will be performed at the clinic by study staff.
Primary Purpose:
Other
Official Title:
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM)
Actual Study Start Date :
Oct 12, 2020
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CGM Users

Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement.

Device: Continuous Glucose Monitoring System
Continuous Glucose Monitoring System

Outcome Measures

Primary Outcome Measures

  1. System Performance [10 days]

    System Performance will be characterized with respect to comparator venous plasma measurements.

Secondary Outcome Measures

  1. System Related Adverse Device Effects [10 days]

    System will be characterized by Adverse Device Effects experienced by study participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Ages 2 or older

  • Diagnosis of Type 1 diabetes or Type 2 diabetes

  • Willing to wear the required number of Systems for the total duration of study wear

  • Willing to participate in Clinic Session(s) during study wear

Exclusion Criteria:

  • Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin

  • Known allergy to medical-grade adhesives

  • Pregnancy

  • Hematocrit outside specification

  • ≥ 18 years of age:

  • Male: 36.0%;

  • Female: 33.0%;

  • 13-17 years of age: 35.0%;

  • 7 years - 12 years of age: 32.0%;

  • End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period

  • Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period

Contacts and Locations

Locations

Site City State Country Postal Code
1 AMCR Institute Escondido California United States 92025
2 Barbara Davis Center Aurora Colorado United States 80045
3 Rocky Mountain Clinical Research Idaho Falls Idaho United States 82404
4 Endeavor Clinical Trials San Antonio Texas United States 78229

Sponsors and Collaborators

  • DexCom, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT04645641
Other Study ID Numbers:
  • PTL-904120
First Posted:
Nov 27, 2020
Last Update Posted:
Nov 27, 2020
Last Verified:
Nov 1, 2020
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

Study Results

No Results Posted as of Nov 27, 2020