Diabetes MellitusNCT00892151

Evaluation of GLUCOFACTS® Deluxe Diabetes Management System

A study testing GLUCOFACTS® Deluxe in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus
What is being tested?: GLUCOFACTS® Deluxe
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Apr 2009to Apr 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Lay users must:
Be at least 18 years of age (at least 80% must be 55 years or less)
Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home
Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month
Be able to speak, read, and understand English
Have experience using PC programs or browsing the internet

Show all 9Show fewer

Have utilized diabetes management software at home in the last year (at least 75% of lay users) or be familiar with diabetes management software
HCPs must:
Have experience using diabetes data management software in the medical office or assist in patients' diabetes disease management using software

Who cannot join

Person working for a competitive medical device company
Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

AMCR Institute
Escondido, California, 92026

Other trials in United States

About this study

Official title: Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting

The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.

Read the detailed description

Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.

Conditions: Diabetes Mellitus
Being tested: GLUCOFACTS® Deluxe
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GLUCOFACTS® DeluxeDevice
Diabetes Data Management Software

Study groups in NCT00892151
Study group	Role	What they receive
Intended Users of the Software	Experimental	10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) using a diabetes data management program. Receives: Device: GLUCOFACTS® Deluxe

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Study staff rated participants on their success at perfoming specific tasks. The rating scale was:
1. = Successful
2. = Successful after being referred to user instructions
3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
5. = Problem encountered with software
Measured: 1-2 hours

Secondary outcomes (2)

Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Subjects rated ease of using the software with respect to specific tasks. The rating scale was:
1. = Very Simple
2. = Simple
3. = Neither Simple nor Difficult
4. = Difficult
5. = Very Difficult
Measured: 1-2 hours
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
User instructions included online help, User Guide, and a Quick Reference Guide. Subjects rated their clarity and usefulness and the rating scale was:
1. = Unacceptable
2. = Poor
3. = Good
4. = Very Good
5. = Excellent
Measured: 1-2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Apr 2009

First posted4 May 2009 (estimated)
Study startApr 2009
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00892151
Sponsor's protocol ID: CTD-2009-01
Status last verified: Jan 2016
First submitted: 1 May 2009
Last updated: 29 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting
ClinicalTrials.gov ID: NCT00892151
Acronym / sponsor ID: CTD-2009-01
Conditions: Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Ascensia Diabetes CareIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 4 May 2009 (estimated)
Results: Posted 18 May 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intended Users of the Software	Experimental	Device: GLUCOFACTS® Deluxe10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) using a diabetes data management program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Be at least 18 years of age (at least 80% must be 55 years or less)
Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home
Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month
Be able to speak, read, and understand English
Have experience using PC programs or browsing the internet

Key exclusion criteria (2 listed)

Person working for a competitive medical device company
Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GLUCOFACTS® DeluxeDiabetes Data Management Software	Device	Intended Users of the Software

Primary outcome

Number of Participants Rated Successful (<=3) at Performing Specific Tasks
Time frame: 1-2 hours
Study staff rated participants on their success at perfoming specific tasks. The rating scale was: 1. = Successful 2. = Successful after being referred to user instructions 3. = Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.) 4. = Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.) 5. = Problem encountered with software

2 secondary outcomes

Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
Time frame: 1-2 hours
Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
Time frame: 1-2 hours

Results and safety

Results posted to the registry on 18 May 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intended Users of the Software	51	50

Primary outcome: Number of Participants Rated Successful (<=3) at Performing Specific Tasks

Time frame: 1-2 hours. Number. Unit: participants

Measure	Intended Users of the Software n = 50
Start Glucofacts® Deluxe	50
Set up Patient Profile (New User)	50
Download CONTOUR meter	50
Display the 'standard day' report	50
Display the logbook	50
Enter a Hemoglobin A1c result to the logbook	50
Find A1c result in logbook	50
Change Blood sugar (BS) ranges in the software	50

Population analysed: Note: 2 tasks were performed only by the 10 healthcare professionals. Also, one lay person was withdrawn (leaving 50 participants). The subject was a parent of a child with diabetes;the 17 year old child performed the software evaluation instead of the parent. Data for the subject withdrawn from the study was not used in the analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intended Users of the Software	0 of 51 (0%)	0 of 51 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingPhase 3
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Type 2 Diabetes
Active, not recruiting
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Recruiting
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Recruiting
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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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.

Timothy Bailey, MD principal investigator

AMCR Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GLUCOFACTS® Deluxe in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 1 site in United States.

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 9 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 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 18 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Rated Successful (<=3) at Performing Specific Tasks (time frame: 1-2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00892151.

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 29 Feb 2016.