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Completed

NCT Number: NCT03638349

Actions & Insights Evaluating a Novel Diabetes Management Solution

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

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Key information

Conditions

Diabetes Mellitus ( Type 1 and Type 2) Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham Heartlands Hospital, Birmingham, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: 1 hour

    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.

Secondary outcomes

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

    Time frame: 1 hour

    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.

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

    Time frame: 1 hour

    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.

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

    Time frame: 1 hour

    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.

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

    Time frame: 1 hour

    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.

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

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

LifeScan Scotland Ltd

Industry

Registry information

Official study title

Actions & Insights Evaluating a Novel Diabetes Management Solution.

Acronym: ASCEND

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 20, 2018
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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