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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: LifeScan's new BGMS

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mike Grady; Phone Number: 01463 721000; Email: MGRADY@lifescan.com
• Study Contact Backup: Name: Kirsty Macleod; Email: kmacleod@lifescan.com

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

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planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn.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

How is the study designed?

Design Details

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

Number of Arms

1

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	A1c change from baseline after 12 weeks in subjects using new BGMS compared to subjects' pre-study glycemic control	12 weeks

Collaborators and Investigators

• Sponsor: LifeScan Scotland Ltd

Study record dates

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