Actions & Insights Evaluating a Novel Diabetes Management Solution

Actions & Insights Evaluating a Novel Diabetes Management Solution.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03638349

Acronym

ASCEND

Enrollment

163

Registered

2018-08-20

Start date

2018-07-17

Completion date

2018-08-10

Last updated

2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus ( Type 1 and Type 2)

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
Scaled preference questionnaires on new blood glucose monitoring digital tool.	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

Measure	Time frame	Description
Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject subject numeracy.	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.
Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 1 subjects.	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.
Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 2 subjects.	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.
Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject A1c.	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.
Preference questionnaires on new blood glucose monitoring digital tool based on insulin or non-insulin using subjects	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.

Countries

United Kingdom

Outcome results