Trial Outcomes & Findings for One Touch VerioIQ US Clinical Outcomes Study (NCT NCT01627899)

NCT ID: NCT01627899

Last Updated: 2018-08-02

Results Overview

Change in A1C from baseline to week 24

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2018-08-02

Participant Flow

At medical clinic.

Participant milestones

Measure	OneTouch VerioIQ BGMS Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	OneTouch VerioIQ BGMS Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ
Overall Study Study terminated early by sponsor.	5

Baseline Characteristics

No data was analysed including demographics as study was terminated early before any data was collected.

Baseline characteristics by cohort

Measure	OneTouch VerioIQ BGMS n=5 Participants Subjects replaced own Blood Glucose Monitoring system (BGMS) with OneTouch VerioIQ
Age, Customized Unknown	5 Participants n=93 Participants • No data was analysed including demographics as study was terminated early before any data was collected.
Sex/Gender, Customized Unknown	5 Participants n=93 Participants • No data was analysed including demographics as study was terminated early before any data was collected.

PRIMARY outcome

Timeframe: 24 weeks

Population: Study terminated early by sponsor, no analysis completed.

Change in A1C from baseline to week 24

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Study terminated early by sponsor, no analysis completed.

Change in A1C from baseline to week 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks and over time

Population: Study terminated early by sponsor, no analysis completed.

Change in Fasting Plasma Glucose (FPG) from baseline to 24 weeks and over time

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Study terminated early by sponsor, no analysis completed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 weeks

Population: Study terminated early by sponsor, no analysis completed.

Outcome measures

Outcome data not reported

Adverse Events

OneTouch VerioIQ BGMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mike Grady

LifeScan Scotland

Phone: +44 01463 721000

Email: MGRADY@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place