Customer Outcomes & Value Experiencing A New Monitoring Technology
CONVERT
1 other identifier
interventional
170
1 country
2
Brief Summary
To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Feb 2020
Shorter than P25 for not_applicable diabetes-mellitus
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2020
CompletedStudy Start
First participant enrolled
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedSeptember 9, 2020
September 1, 2020
8 months
February 7, 2020
September 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
A1c change from baseline after 12 weeks
A1c change from baseline after 12 weeks in subjects using new BGMS compared to subjects' pre-study glycemic control
12 weeks
Study Arms (1)
Intervention 01
EXPERIMENTALSubjects use new LifeScan provided BGMS for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with Type 1 diabetes mellitus or Type 2 diabetes mellitus for ≥ 3 month prior to screening
- Currently performing self-monitoring of blood glucose (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:
- Currently using a continuous or flash glucose monitoring
- 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or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn.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
Study Sites (2)
Royal Infirmary of Edinburgh
Edinburgh, Lothian, EH16 4SA, United Kingdom
Highland Diabetes Institute
Inverness, IV2 3JH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
February 7, 2020
First Posted
February 10, 2020
Study Start
February 7, 2020
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
September 9, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Up to 12 months post study completion.
- Access Criteria
- Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Device being used in the study is CE marked and will be used as intended therefore risk is minimal. What? Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices). When? Beginning 9 months and ending 36 months following article publication. With whom? Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. For individual participant data meta-analysis. By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available from our archive but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found by reaching out to the study contact listed. What other documents will be available?Abbreviated CSR may be provided upon request and assessment by the company.