DiabetesNCT00803777

In-Clinic and Home-Use Study of a New Blood Glucose Monitoring System

A study testing Investigational Blood Glucose Monitoring System in people with Diabetes, 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

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Trial summary

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter. Read more about this study

Who is it for?: Ages 4 to 24 years
Conditions the study is for: Diabetes
What is being tested?: Investigational Blood Glucose Monitoring System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 147 participants
Where: 4 sitesUnited States
Study dates: Dec 2008to Mar 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 4 to 24 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Type 1 diabetes
Age 4 to 24 years
Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment
Has used a handheld game system to play video games within a year of enrollment
If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.
Is willing to complete all study procedures, with appropriate parent/guardian supervision

Who cannot join

Hemophilia or any other bleeding disorder
Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
Infection with a blood borne pathogen (e.g., HIV, hepatitis)
Subject or parent/guardian is employee of competitive medical device company
Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Barbara Davis Center
Aurora, Colorado, 80045
AMCR Institute
Escondido, California, 92026
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Childrens Hospital Los Angeles
Los Angeles, California, 90027

Other trials in United States

About this study

Official title: In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults

The purpose of this study is to evaluate the performance and acceptability of a new blood glucose meter.

Conditions: Diabetes
Being tested: Investigational Blood Glucose Monitoring System
Medical subject headings: Diabetes Mellitus

What participants receive

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

Investigational Blood Glucose Monitoring SystemDevice
Subjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.

Study groups in NCT00803777
Study group	Role	What they receive
Intended Users of the Monitoring System	Experimental	Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable. Receives: Device: Investigational Blood Glucose Monitoring System

What is being measured

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

Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values <75mg/dL) or +/- 20% (for reference blood glucose values >/= 75mg/dL)of the reference results were calculated.
Measured: 1-2 hours
Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results
Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated.
Measured: 1-2 hours

Secondary outcomes (3)

Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies
The Parkes Error Grid, developed from a survey of 100 clinicians, plots combinations of BG meter measurements against reference method results. Each (x,y) point on the grid is within a risk category, assigned by the clinicians surveyed. Risk categories (increasing severity): ZoneA: No effect on clinical action; ZoneB: Altered clinical action or little/no effect on clinical outcome; ZoneC: Altered clinical action likely to effect clinical outcome; ZoneD: Altered clinical action could have significant medical risk; ZoneE: Altered clinical action could have dangerous consequences
Measured: 1-2 hours
Number of Participants Rated as <=2 (Labeling Comprehension)
Subjects or parents/guardians, as applicable, performed meter tasks after reading the User Guide and Quick Reference Guide. The study staff rated the participants on their success at performing the tasks as follows:
1. Successful in performing tasks correctly without assistance
2. Successful after study staff prompted participant to review User Guide.
3. Successful after study staff assisted subject. (Similar to review of a specific function during a Customer Service call.)
4. Subject did not perform task correctly and study staff intervention was required.
Measured: 1-2 hours
Average Within Replicate Coefficient of Variation CV (Precision)
The average Coefficient of Variation (CV) was computed by calculating the square of the CV for each pair of Blood Glucose (BG) self-test results, averaging this square value over the number of subjects included in the analysis, and then taking the square root.
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.

Dec 2008Mar 2009

First posted8 Dec 2008 (estimated)
Study startDec 2008
Primary completionMar 2009
Study completionMar 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies 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: 147 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00803777
Sponsor's protocol ID: CTD-2008-23
Status last verified: Jan 2016
First submitted: 5 Dec 2008
Last updated: 29 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000 Aug;23(8):1143-8. doi: 10.2337/diacare.23.8.1143.
PubMed 10937512

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?

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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: In-Clinic and Home-Use Study of the AVATAR Blood Glucose Monitoring System in Children and Young Adults
ClinicalTrials.gov ID: NCT00803777
Acronym / sponsor ID: CTD-2008-23
Conditions: Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 147 participants (actual)
Lead sponsor: Ascensia Diabetes CareIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 8 Dec 2008 (estimated)
Results: Posted 16 Jun 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 the performance and acceptability of a new blood glucose meter.

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 Monitoring System	Experimental	Device: Investigational Blood Glucose Monitoring SystemSubjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.

Who may qualify

Ages: 4 to 24 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Type 1 diabetes
Age 4 to 24 years
Routinely performs blood glucose testing at home, at least 2 times per day, for one month or more before enrollment
Has used a handheld game system to play video games within a year of enrollment
If above age 18, subject is able to speak, read, and understand English. If below age 18, subject's parent/guardian is able to speak, read, and understand English, and is able to provide appropriate supervision.

Key exclusion criteria (5 listed)

Hemophilia or any other bleeding disorder
Taking prescription anticoagulants (such as Warfarin or heparin) or has clotting problems that may prolong bleeding. Taking Plavix or aspirin daily is not excluded
Infection with a blood borne pathogen (e.g., HIV, hepatitis)
Subject or parent/guardian is employee of competitive medical device company
Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or 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
Investigational Blood Glucose Monitoring SystemSubjects with diabetes used a new blood glucose monitoring system with capillary blood. Certain results were compared to a laboratory glucose method.	Device	Intended Users of the Monitoring System

Primary outcome

Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
Time frame: 1-2 hours
Subjects with diabetes (or parents/guardians) and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were obtained in duplicate from subjects(158 BG results possible). The number of capillary results within +/- 15mg/dL (for reference blood glucose values <75mg/dL) or +/- 20% (for reference blood glucose values >/= 75mg/dL)of the reference results were calculated.
Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results
Time frame: 1-2 hours
Duplicate subject Blood Glucose Monitoring System (BGMS) results were compared to healthcare professional (HCP) BGMS results (possible number of results = 292). The number of Subject BGM results within +/- 15mg/dL (for reference BG values <75mg/dL) and within +/- 20% (for reference BG values >= 75mg/dL)of the HCP results was calculated.

3 secondary outcomes

Numbers of BG Results in Zones of the Parkes Error Grid of Clinical Significance of Inaccuracies
Time frame: 1-2 hours
Number of Participants Rated as <=2 (Labeling Comprehension)
Time frame: 1-2 hours
Average Within Replicate Coefficient of Variation CV (Precision)
Time frame: 1-2 hours

Results and safety

Results posted to the registry on 16 Jun 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 Monitoring System	147	147

Primary outcome: Number of Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method

Time frame: 1-2 hours. Number. Unit: number of capillary results (n=79x2)

Measure	Intended Users of the Monitoring System n = 79
Subjects' Test Results (n=158)	142
HCP Test Results (n=157)	143

Population analysed: Some subjects \>=13 years old consented to provide larger capillary samples for YSI glucose analysis. Subjects and HCPs provided duplicate results, but one subject's HCP provided only one glucose result. One subject sample was too small to run the YSI analysis; another subject was given carbohydrate to prevent low blood sugar (no results obtained)

Primary outcome: Number of Duplicate Subject BGM Results Within +/- 15mg/dL or +/- 20% of Healthcare Professional Capillary Results

Time frame: 1-2 hours. Number. Unit: number of Subject BGM Results (n=146x2)

Measure	Intended Users of the Monitoring System n = 146
Value	277

Population analysed: One subject's results were not used because the subject was given carbohydrate to prevent low blood sugar.

3 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 Monitoring System	0 of 147 (0%)	0 of 147 (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.
Results publication: PubMed 10937512Parkes JL, Slatin SL, Pardo S, Ginsberg BH. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000 Aug;23(8):1143-8. doi: 10.2337/diacare.23.8.1143.

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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.

Javier Aisenberg, MD principal investigator

Hackensack Meridian Health

Georgeanna Klingensmith, MD principal investigator

Barbara Davis Center

Francine Kaufman, MD principal investigator

Children's Hospital Los Angeles

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

Questions about this trial

What is this clinical trial studying?

A study testing Investigational Blood Glucose Monitoring System in people with Diabetes, 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 6 inclusion and 5 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 16 Jun 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 Duplicate Capillary Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method (time frame: 1-2 hours). The study lists 2 primary outcomes in all. 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 NCT00803777, which also lists 1 linked publication.

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.