Diabetes Mellitus ( Type 1 and Type 2)ASCENDNCT03638349
Actions & Insights Evaluating a Novel Diabetes Management Solution
An observational study of Diabetes Mellitus ( Type 1 and Type 2), run by LifeScan Scotland Ltd at 3 sites in United Kingdom.
Trial summary
Single visit outcome study to obtain qualitative and quantitative data for a new BGMS. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes Mellitus ( Type 1 and Type 2)
- How many people
- 163 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 17 Jul 2018to 10 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 150 male or female subjects with Type 1 or Type 2 Diabetes Mellitus.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Birmingham Heartlands Hospital
Birmingham
Royal Infirmary of Edinburgh
Edinburgh
Highland Clinical Research Facility
Inverness
About this study
Official title: Actions & Insights Evaluating a Novel Diabetes Management Solution.
Single visit outcome study to obtain qualitative and quantitative data for a new BGMS.
Read the 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.
- Conditions
- Diabetes Mellitus ( Type 1 and Type 2)
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start17 Jul 2018
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus ( Type 1 and Type 2)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeScan Scotland Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Grady, Study director, LifeScan Scotland Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638349
- Sponsor's protocol ID
- 3172697
- Acronym
- ASCEND
- Status last verified
- Sep 2020
- First submitted
- 26 Jul 2018
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actions & Insights Evaluating a Novel Diabetes Management Solution.
- ClinicalTrials.gov ID
- NCT03638349
- Acronym / sponsor ID
- ASCEND / 3172697
- Conditions
- Diabetes Mellitus ( Type 1 and Type 2)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- LifeScan Scotland LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 150 male or female subjects with Type 1 or Type 2 Diabetes Mellitus.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 1 subjects.
Time frame: 1 hour
Scaled preference questionnaires on new blood glucose monitoring digital tool for Type 2 subjects.
Time frame: 1 hour
Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject A1c.
Time frame: 1 hour
Scaled preference questionnaires on new blood glucose monitoring digital tool based on subject subject numeracy.
Time frame: 1 hour
Preference questionnaires on new blood glucose monitoring digital tool based on insulin or non-insulin using subjects
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Grady study director
LifeScan Scotland Ltd
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus ( Type 1 and Type 2), run by LifeScan Scotland Ltd at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scaled preference questionnaires on new blood glucose monitoring digital tool. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.