NCT03920085

Brief Summary

Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2019

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
Last Updated

February 28, 2020

Status Verified

March 1, 2019

Enrollment Period

28 days

First QC Date

April 5, 2019

Last Update Submit

February 26, 2020

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%).

    Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%).

    Less than 30 minutes

Study Arms (1)

LifeScan BGMSs

EXPERIMENTAL

OneTouch Verio, OneTouch Select Plus and OneTouch Ultra Blood Glucose Monitoring Systems (BGMSs) tested using subject capillary blood and compared to a reference instrument (YSI 2900).

Device: OneTouch VerioDevice: OneTouch Select PlusDevice: OneTouch Ultra

Interventions

OneTouch VerioDEVICE

OneTouch Verio Blood Glucose Monitoring System.

LifeScan BGMSs
OneTouch Select PlusDEVICE

OneTouch Select Plus Blood Glucose Monitoring System.

LifeScan BGMSs
OneTouch UltraDEVICE

OneTouch Ultra Blood Glucose Monitoring System.

LifeScan BGMSs

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be enrolled in LifeScan Patient Registry.
  • Participants must have read the Information sheet and signed an informedconsent form \>prior to study participation.
  • Participants must be 16 years or older.
  • Participants must be diagnosed with Diabetes

You may not qualify if:

  • \> Participants not enrolled in the LifeScan Patient Registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAC Clinical Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 18, 2019

Study Start

January 8, 2019

Primary Completion

February 5, 2019

Study Completion

February 5, 2019

Last Updated

February 28, 2020

Record last verified: 2019-03

Locations

GB(1)