- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03638349
Actions & Insights Evaluating a Novel Diabetes Management Solution (ASCEND)
September 8, 2020 updated by: LifeScan Scotland Ltd
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
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Birmingham, United Kingdom
- Birmingham Heartlands Hospital
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Edinburgh, United Kingdom
- Royal Infirmary of Edinburgh
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Inverness, United Kingdom
- Highland Clinical Research Facility
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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.
Time Frame: 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.
|
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.
Time Frame: 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.
|
1 hour
|
Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 2 subjects.
Time Frame: 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.
|
1 hour
|
Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject A1c.
Time Frame: 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.
|
1 hour
|
Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject subject numeracy.
Time Frame: 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.
|
1 hour
|
Preference questionnaires on new blood glucose monitoring digital tool based on insulin or non-insulin using subjects
Time Frame: 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.
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mike Grady, LifeScan Scotland Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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