NCT03638349

Brief Summary

Single visit outcome study to obtain qualitative and quantitative data for a new BGMS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

July 17, 2018

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

24 days

First QC Date

July 26, 2018

Last Update Submit

September 8, 2020

Conditions

Diabetes Mellitus ( Type 1 and Type 2)

Outcome Measures

Primary Outcomes (1)

  • Scaled preference questionnaires on new blood glucose monitoring digital tool.

    Proportion of positive responses from scaled response questionnaires, scaled from 1 to 6, 1 being the most negative response and 6 being the most positive.

    1 hour

Secondary Outcomes (5)

  • Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 1 subjects.

    1 hour

  • Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 2 subjects.

    1 hour

  • Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject A1c.

    1 hour

  • Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject subject numeracy.

    1 hour

  • Preference questionnaires on new blood glucose monitoring digital tool based on insulin or non-insulin using subjects

    1 hour

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 150 male or female subjects with Type 1 or Type 2 Diabetes Mellitus.

You may qualify if:

  • Diagnosed with T1DM or T2DM
  • Performs SMBG
  • Male or female, at least 16 years old.
  • Able to communicate (speak, read and write) in English
  • Willing to sign an informed consent.

You may not qualify if:

  • Unlikely to be compliant with the study in the opinion of study staff.
  • Conflict of Interest - Prospective Participants are currently working for, previously worked for, or have an immediate family member currently working for a company that manufactures or markets the products tested under this procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Highland Clinical Research Facility

Inverness, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Mike Grady

    LifeScan Scotland Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 20, 2018

Study Start

July 17, 2018

Primary Completion

August 10, 2018

Study Completion

August 10, 2018

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)