Diabetes MellitusNCT00782496

Glucose Meter Study

A study testing Education + new meter and Education + new meter + feature activation in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 4 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate if the meal marker and reminder feature of the Contour meter along with education maintains or increases frequency of testing blood sugar after meals and enables behavioral changes that may lead to improvement in glycemic control. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Diabetes Mellitus
What is being tested?: Education + new meter and Education + new meter + feature activation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 211 participants
Where: 4 sitesUnited States
Study dates: Nov 2008to Sep 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 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Persons with type 1 or type 2 diabetes
Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
Persons at least 21 years of age
Persons willing to complete all study visits and study procedures including:
Using the meal-marker + reminder feature regularly (Group 2 subjects only)
Using the paper logbook provided (both Groups)

Show all 9Show fewer

Testing their BG at least 3 times a day during the entire study.
Persons who are able to speak, read and understand English
Persons who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more

Who cannot join

Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
Persons who test over 6 times/day regularly
Persons who wear a BG sensor 2 weeks or more during each month.
Persons with home heath aides who assist with their BG testing.
Persons with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
Significant visual impairment

Show all 10Show fewer

Significant hearing impairment
Cognitive disorder
Significant unstable co-morbidity (with notable change within the past 3 months)
Any other condition as per investigator's discretion

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Atlanta Diabetes Associates
Atlanta, Georgia, 30309
International Diabetes Center
Minneapolis, Minnesota, 55416
Mount Sinai School of Medicine
New York, New York, 10029
University of Washington Medical Center/Diabetes Care Center
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients

Conditions: Diabetes Mellitus
Being tested: Education + new meter, Education + new meter + feature activation
Medical subject headings: Diabetes Mellitus

What participants receive

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

Education + new meterDevice
Diabetes education and a new meter with basic features
Education + new meter + feature activationDevice
Diabetes education and a new meter with advanced features

Study groups in NCT00782496
Study group	Role	What they receive
Level1 Basic Meter Features	Experimental	Adults with type 1 and type 2 diabetes use only basic features (Level 1) to test their blood. The CONTOUR meter has the basic features such as small meter size, easy to use , No Coding™ technology, 5-second test time, small sample size (0.6 µL), automatic control solution marking, 480 reading memory capacity. Receives: Device: Education + new meter
Level 2 Advanced Meter Features	Experimental	Adults with type 1 and type 2 diabetes additionally access and use more advanced meter features(Level 2)during blood glucose testing. The advanced features include ability to mark blood glucose values as obtained before or after meals or to set an audible reminder to test. Receives: Device: Education + new meter + feature activation

What is being measured

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

Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features
Measured: 6 months

Secondary outcomes (1)

Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2
Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.
Measured: Over six month period

Timeline

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

Nov 2008Sep 2009

First posted31 Oct 2008 (estimated)
Study startNov 2008
Primary completionSep 2009
Study completionSep 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00782496
Sponsor's protocol ID: CTD-2008-09
Status last verified: Jan 2016
First submitted: 28 Oct 2008
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

RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty

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: A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients
ClinicalTrials.gov ID: NCT00782496
Acronym / sponsor ID: CTD-2008-09
Conditions: Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: Ascensia Diabetes CareIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 31 Oct 2008 (estimated)
Results: Posted 30 Nov 2010

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Level1 Basic Meter Features	Experimental	Device: Education + new meterAdults with type 1 and type 2 diabetes use only basic features (Level 1) to test their blood. The CONTOUR meter has the basic features such as small meter size, easy to use , No Coding™ technology, 5-second test time, small sample size (0.6 µL), automatic control solution marking, 480 reading memory capacity.
Level 2 Advanced Meter Features	Experimental	Device: Education + new meter + feature activationAdults with type 1 and type 2 diabetes additionally access and use more advanced meter features(Level 2)during blood glucose testing. The advanced features include ability to mark blood glucose values as obtained before or after meals or to set an audible reminder to test.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Persons with type 1 or type 2 diabetes
Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
Persons at least 21 years of age
Persons willing to complete all study visits and study procedures including:
Testing their BG at least 3 times a day during the entire study.

Key exclusion criteria (10 listed)

Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
Persons who test over 6 times/day regularly
Persons who wear a BG sensor 2 weeks or more during each month.
Persons with home heath aides who assist with their BG testing.
Persons with the following impairments which, in the opinion of the investigator, would seriously 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
Education + new meterDiabetes education and a new meter with basic features	Device	Level1 Basic Meter Features
Education + new meter + feature activationDiabetes education and a new meter with advanced features	Device	Level 2 Advanced Meter Features

Primary outcome

Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features
Time frame: 6 months

1 secondary outcome

Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2
Time frame: Over six month period

Results and safety

Results posted to the registry on 30 Nov 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
Level1 Basic Meter Features	106	92
Level 2 Advanced Meter Features	105	90

Primary outcome: Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features

Time frame: 6 months. Mean (Standard Error). Unit: number of post-prandial tests per week

Measure	Level1 Basic Meter Features n = 74	Level 2 Advanced Meter Features n = 68
Value	7.1 (0.72)	10.2 (0.72)

Population analysed: For level 1, 14 subjects were lost to follow-up, that is they did not continue through the study's 4 visits, and data was not available. For level 2, 15 subjects were likewise lost to follow-up and data was not available. For units analyzed, 74 and 68 refer to the number of logbooks available.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Level1 Basic Meter Features	12 of 106 (11.3%)	0 of 94 (0%)	Not reported
Level 2 Advanced Meter Features	6 of 105 (5.7%)	0 of 99 (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.

Related trials for Diabetes Mellitus

RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty

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.

Dace Trence, MD principal investigator

University of Washington Medical Center/Diabetes Care Center

Bruce W Bode, MD principal investigator

Atlanta Diabetes Associates

Ronald Tamler, MD, Phd, MBA principal investigator

Icahn School of Medicine at Mount Sinai

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

Questions about this trial

What is this clinical trial studying?

A study testing Education + new meter and Education + new meter + feature activation in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 4 sites 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 10 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 4 sites 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 30 Nov 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?

Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features (time frame: 6 months). 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 NCT00782496.

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.