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NCT04262700 Clinical Trial

Customer Outcomes & Value Experiencing A New Monitoring Technology

Diabetes Mellitus Clinical Trial

— CONVERT  

Official title:
Customer Outcomes & Value Experiencing A New Monitoring Technology

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04262700
Other study ID # FILE-PROT-005120
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2020
Est. completion date October 1, 2020

Study information
Verified date September 2020
Source LifeScan Scotland Ltd
Contact Mike Grady
Phone 01463 721000
Email MGRADY@lifescan.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.

Recruitment information / eligibility
Status Recruiting
Enrollment 170
Est. completion date October 1, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria Summary:

- 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

Exclusion Criteria Summary:

- 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or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn.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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• LifeScan's new BGMS
LifeScan new Blood Glucose Monitoring System (BGMS)

Locations
Country Name City State
United Kingdom Royal Infirmary of Edinburgh Edinburgh Lothian
United Kingdom Highland Diabetes Institute Inverness

Sponsors (1)
Lead Sponsor Collaborator
LifeScan Scotland Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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