Customer Outcomes & Value Experiencing A New Monitoring Technology (CONVERT)

September 8, 2020 updated by: LifeScan Scotland Ltd
To investigate whether novel insight features in new Blood Glucose Monitoring System (BGMs) can improve glycemic control.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Inverness, United Kingdom, IV2 3JH
        • Recruiting
        • Highland Diabetes Institute
        • Contact:
          • David MacFarlane, MD
        • Principal Investigator:
          • David MacFarlane, MD
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Recruiting
        • Royal Infirmary of Edinburgh
        • Principal Investigator:
          • Dr. Nicola Zammitt
        • Contact:
          • Alison Sudworth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn.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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention 01
Subjects use new LifeScan provided BGMS for 12 weeks.
Device: LifeScan's new BGMS
LifeScan new Blood Glucose Monitoring System (BGMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A1c change from baseline after 12 weeks
Time Frame: 12 weeks
A1c change from baseline after 12 weeks in subjects using new BGMS compared to subjects' pre-study glycemic control
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeScan Scotland Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 8, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • FILE-PROT-005120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Up to 12 months post study completion.

IPD Sharing Access Criteria

Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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