Actions & Insights Evaluating a Novel Diabetes Management Solution

Diabetes Mellitus ( Type 1 and Type 2) Clinical Trial

— ASCEND  

Official title:

Actions & Insights Evaluating a Novel Diabetes Management Solution.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638349
• Other study ID #: 3172697
• Status: Completed
• Start date: July 17, 2018
• Est. completion date: August 10, 2018

Study information

• Verified date: September 2020
• Source: LifeScan Scotland Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: August 10, 2018
• Est. primary completion date: August 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus ( Type 1 and Type 2)

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Highland Clinical Research Facility	Inverness

Sponsors (1)

Lead Sponsor	Collaborator
LifeScan Scotland Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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