Actions & Insights Evaluating a Novel Diabetes Management Solution

NCT ID: NCT03638349

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-17

Study Completion Date

2018-08-10

Brief Summary

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

Detailed Description

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During ASCEND, patients will complete a single visit clinical study divided into two distinct parts. Part 1 involves each subject completing a number of simple quantitative exercises to gauge their level of comprehension of diabetes related information. Subjects will then continue during the same visit to complete part 2 which involves gathering qualitative feedback from each subject on the new Blood glucose monitoring system.

Conditions

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Diabetes Mellitus ( Type 1 and Type 2)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LifeScan Scotland Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mike Grady

Role: STUDY_DIRECTOR

LifeScan Scotland Ltd

Locations

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Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Site Status

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status

Highland Clinical Research Facility

Inverness, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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3172697

Identifier Type: -

Identifier Source: org_study_id

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