Actions & Insights Evaluating a Novel Diabetes Management Solution (ASCEND)

Actions & Insights Evaluating a Novel Diabetes Management Solution.

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus ( Type 1 and Type 2)

Detailed Description

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 (Actual): 163

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • Birmingham Heartlands Hospital
  • Edinburgh, United Kingdom
    • Royal Infirmary of Edinburgh
  • Inverness, United Kingdom
    • Highland Clinical Research Facility

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

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	1 hour

Collaborators and Investigators

• Sponsor: LifeScan Scotland Ltd
• Investigators: Study Director: Mike Grady, LifeScan Scotland Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2018
• Primary Completion (Actual): August 10, 2018
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 3172697

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No