Assessment of Blood Glucose Monitoring Devices With New Insight Features
1 other identifier
interventional
267
1 country
3
Brief Summary
To investigate whether novel insight features in new BGMs can improve glycemic control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Oct 2016
Shorter than P25 for not_applicable diabetes-mellitus
3 active sites
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
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 22, 2017
CompletedAugust 15, 2017
August 1, 2017
9 months
October 7, 2016
August 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
A1c change from baseline after 12 weeks
A1c change from baseline after 12 weeks in subjects using BGMs with color range indicator and/or pattern messaging tools (i.e., OneTouch Verio® Flex and OneTouch Verio® combined) compared to subjects with either T1 or T2DM using their current BGM, i.e., without color range indicator and/or pattern messaging tools.
12 weeks
Study Arms (3)
Control
ACTIVE COMPARATORSubject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks.
OneTouch Verio®
EXPERIMENTALSubjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks
Intervention 02
EXPERIMENTALSubjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening
- Currently performing SMBG at home for diabetes management decisions
- Willingness to notify the study staff if they become pregnant during the study
- Willing to sign an informed consent
You may not qualify if:
- Is unlikely to be compliant with the diabetes regimen in the opinion of study staff
- Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn
- Conflict of Interest
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeScanlead
Study Sites (3)
Diabetes Centre, Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
NHS Lothian
Edinburgh, EH16 4SA, United Kingdom
Highland Diabetes Institute
Inverness, IV2 3JH, United Kingdom
Related Publications (1)
Grady M, Katz LB, Levy BL. Use of Blood Glucose Meters Featuring Color Range Indicators Improves Glycemic Control in Patients With Diabetes in Comparison to Blood Glucose Meters Without Color (ACCENTS Study). J Diabetes Sci Technol. 2018 Nov;12(6):1211-1219. doi: 10.1177/1932296818775755. Epub 2018 May 31.
PMID: 29848106DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mike Grady
LifeScan Scotland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 11, 2016
Study Start
October 1, 2016
Primary Completion
June 22, 2017
Study Completion
June 22, 2017
Last Updated
August 15, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share