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

LifeScan

Status: Completed

Conditions: Diabetes Mellitus ( Type 1 and Type 2)

Study type: Observational

Funder types: Industry

Identifiers

NCT03638349

3172697

Details and patient eligibility

About

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

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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