Actions & Insights Evaluating a Novel Diabetes Management Solution

Study Overview
=================
Brief Summary
-----------------
Single visit outcome study to obtain qualitative and quantitative data for a new BGMS.

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.

Official Title
-----------------
Actions & Insights Evaluating a Novel Diabetes Management Solution.

Conditions
-----------------
Diabetes Mellitus ( Type 1 and Type 2)

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
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 |