NCT03638349 - Actions & Insights Evaluating a Novel Diabetes Management Solution | Crick | Crick

Actions & Insights Evaluating a Novel Diabetes Management Solution

N/ACompletedNCT03638349

LifeScan Scotland Ltd163 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

163

Conditions

Diabetes Mellitus ( Type 1 and Type 2)

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Summary off: 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

Locations (3)

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Highland Clinical Research Facility

Inverness, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 1 hour

Secondary Outcomes

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

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.

Time frame: 1 hour

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

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.

Time frame: 1 hour

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

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.

Time frame: 1 hour

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

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.

Time frame: 1 hour

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

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.

Data from ClinicalTrials.gov

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