Diabetes MellitusNCT00797563

Evaluation of a New Blood Glucose Meter System With Capillary and Venous Blood

A study testing Apollo Blood Glucose Monitoring System 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 the study was to evaluate the performance of the meter system in the hands of subjects and healthcare professionals (HCPs). It also evaluated the product user guides in the hands of untrained subjects. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Apollo Blood Glucose Monitoring System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Nov 2008
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have type 1 or type 2 diabetes
Be > 18, < 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age
Be willing to complete all study procedures
Be routinely testing their blood sugar at home (at least once per day)
Be able to speak, read, and understand English and understand the Informed Consent document
Be able to read the labeling instructions

Who cannot join

Minors < 18 years of age and adults > 75 years of age
Pregnancy
Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
Disorders in the fingertip lancing areas
Acute or chronic infections, particularly skin infections
Infection with a blood borne pathogen

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Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81 mg or 325 mg) is not reason for exclusion
Hemophilia or any other bleeding disorder
Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study
Working for a competitive medical device company

Trial locations and contacts

1 site in 1 country.

United States1 site

Consumer Product Testing Co., Inc.
Fairfield, New Jersey, 07004

Other trials in United States

About this study

Official title: Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]

Read the detailed description

The study evaluated the performance of the blood glucose meter system (BGMS) compared to a laboratory glucose method. Subjects and healthcare professionals tested subject capillary blood and healthcare professionals tested subject venous blood. Two meter configurations were evaluated. The study evaluated the acceptability of product labeling in enabling subjects to perform blood glucose testing with the new meter system and for using meter features. Subjects and healthcare professionals provided feedback about the BGMS and its features.

Conditions: Diabetes Mellitus
Being tested: Apollo 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.

Apollo Blood Glucose Monitoring SystemDevice
Also called CONTOUR® USB
Subjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).

Study groups in NCT00797563
Study group	Role	What they receive
Subjects with diabetes	Other	Subjects with diabetes use a new blood glucose monitoring system (BGMS) Apollo Blood Glucose Monitoring System with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood. Receives: Device: Apollo Blood Glucose Monitoring System

What is being measured

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

Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.
Measured: One hour

Secondary outcomes (2)

Percentage of Participants Rated as <=3 (Labeling Comprehension)
Study staff rated participants on their success at performing BG testing and Autolog feature after reading product labeling. 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.)
Measured: One hour
Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter
Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitoring System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).
Measured: One hour

Timeline

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

Nov 2008Nov 2008

First posted25 Nov 2008 (estimated)
Study startNov 2008
Primary completionNov 2008
Study completionNov 2008

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: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00797563
Sponsor's protocol ID: CTD-2008-17
Status last verified: Jan 2016
First submitted: 24 Nov 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?

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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: Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Capillary and Venous Blood [Commercial Name is CONTOUR® USB]
ClinicalTrials.gov ID: NCT00797563
Acronym / sponsor ID: CTD-2008-17
Conditions: Diabetes Mellitus
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Ascensia Diabetes CareIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 25 Nov 2008 (estimated)
Results: Posted 22 Dec 2009

Clinical summary

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

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
Subjects with diabetes	Other	Device: Apollo Blood Glucose Monitoring SystemSubjects with diabetes use a new blood glucose monitoring system (BGMS) Apollo Blood Glucose Monitoring System with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Have type 1 or type 2 diabetes
Be > 18, < 76 year of age at time of consent, with approximately 50% (+10%)being less than 55 years of age
Be willing to complete all study procedures
Be routinely testing their blood sugar at home (at least once per day)
Be able to speak, read, and understand English and understand the Informed Consent document

Key exclusion criteria (10 listed)

Minors < 18 years of age and adults > 75 years of age
Pregnancy
Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS
Disorders in the fingertip lancing areas
Acute or chronic infections, particularly skin infections

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
Apollo Blood Glucose Monitoring SystemAlso: CONTOUR® USBSubjects with diabetes use a new blood glucose monitoring system with capillary blood; healthcare professionals use the new blood glucose monitoring system with subject capillary and venous blood. All results are compared to a laboratory glucose method - Yellow Springs Instrument (YSI).	Device	Subjects with diabetes

Primary outcome

Number of Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method
Time frame: One hour
Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject capillary blood. HCPs used the new bgms with subject venous blood. All results were compared to a lab glucose method. The BGMS has programmed algorithms to provide results equivalent to either serum/plasma or whole blood glucose methods. Number of results were obtained by combining results from three lots of Contour Blood Glucose strips.

2 secondary outcomes

Percentage of Participants Rated as <=3 (Labeling Comprehension)
Time frame: One hour
Number of Partipants Who Gave These Ratings for Overall Testing Experience With This Meter
Time frame: One hour

Results and safety

Results posted to the registry on 22 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects With Diabetes	102	101

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

Time frame: One hour. Number. Unit: number of blood glucose (BG) results

Measure	Subjects With Diabetes n = 101
Subjects: Capillary Plasma (n=300)	273
HCPs: Capillary Plasma (n=300)	274
Subjects: Capillary Whole Blood (n=300)	280
HCPs: Capillary Whole Blood (n=299)	273
HCPs: Venous Plasma (n=605)	597
HCPs: Venous Whole Blood (n=606)	603

Population analysed: One subject had a non-serious, non-device related anticipated adverse event (a low blood glucose concentration). The subject was treated and discontinued the study. The tube collected for the capillary lab glucose assay from one subject was lost in processing, so 100 capillary and 101 venous samples were compared with the lab method.

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
Subjects With Diabetes	0 of 102 (0%)	0 of 102 (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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Recruiting
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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.

Joy Frank, RN principal investigator

Consumer Product Testing Co., Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing Apollo Blood Glucose Monitoring System 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 6 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 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 22 Dec 2009). 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 Capillary and Venous Results Within +/- 15mg/dL or +/- 20% of Laboratory Glucose Method (time frame: One hour). 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 NCT00797563.

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.