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A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03851549
Recruitment Status : Unknown
Verified March 2019 by LifeScan Scotland Ltd.
Recruitment status was:  Not yet recruiting
First Posted : February 22, 2019
Last Update Posted : March 8, 2019
Sponsor:
Collaborator:
Institut für Diabetes-Technologie ( IfDT)
Information provided by (Responsible Party):
LifeScan Scotland Ltd

Study Description
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Brief Summary:
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: New BGMS (US) Not Applicable

Detailed Description:

User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C.

Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.
Estimated Study Start Date : March 12, 2019
Estimated Primary Completion Date : April 19, 2019
Estimated Study Completion Date : April 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Blood Glucose monitoring System (BGMS)
Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300)
 Device: New BGMS (US)
New blood glucose monitoring system / In vitro diagnostic device (IVDD)


Outcome Measures
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Primary Outcome Measures :
  1. User Performance ( UP) [ Time Frame: < 30 minutes ]
    User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument.

  2. System Use Evaluation [ Time Frame: < 30 minutes ]
    System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Summary of inclusion criteria:

Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group.

Summary of exclusion criteria:

Conflict of interest. Technical expertise.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851549


Contacts
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Contact: Lorna Stewart +44 01463 721000 LSTEWAR5@its.jnj.com
Contact: Laura Ritchie +44 01463 721000 lritchi6@its.jnj.com

Locations
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Germany
Institut für Diabetes-Technologie
Ulm, Germany, D-89081
Contact: Annnette Baumstark       annette.baumstark@idt-ulm.de   
Contact: Barry Irvine       BIRVINE1@its.jnj.com   
Principal Investigator: Dr. Nina Jendrike         
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SA
Contact: Barry Irvine       BIRVINE1@its.jnj.com   
Principal Investigator: Dr. Nicola Zammitt         
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Contact: Laura Ritchie       lritchi6@its.jnj.com   
Principal Investigator: Dr. Srikanth Bellary         
Centre for Health Science
Inverness, United Kingdom, IV2 3JH
Contact: Danielle King       dking38@its.jnj.com   
Principal Investigator: Dr. David Macfarlane         
Sponsors and Collaborators
LifeScan Scotland Ltd
Institut für Diabetes-Technologie ( IfDT)
Investigators
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Study Director: Kirsty Macleod LifeScan Scotland
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: LifeScan Scotland Ltd
ClinicalTrials.gov Identifier: NCT03851549    
Other Study ID Numbers: 3178226
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No