Diabetes MellitusNCT00797212
A New Glucose Meter With Alternative Site Testing
A study testing Apollo Blood Glucose Monitoring System in people with Diabetes Mellitus, run by Ascensia Diabetes Care at 1 site in United States.
Trial summary
The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST). 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
- 50 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 years 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 (81mg 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.
About this study
Official title: Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]
The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).
Read the detailed description
The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.
- 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 Commercial name is CONTOUR® USB
Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with diabetes | Other | Subjects with diabetes use a new Apollo Blood Glucose Monitoring System with blood obtained from the palm and forearm 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 AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results
Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP
Measured: One hour
Secondary outcomes (2)
Percentage of Participants Rated as <=3 (Labeling Comprehension)
Study staff rated participants as to their success at performing meter testing. The rating scale was:
- Successful
- Successful after being referred to user instructions
- Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.)
- Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)
Measured: One hour
Percentage of Participant Ratings for Overall Testing Experience With This Meter
Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor 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.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vimala Sethy, MD, PhD, Principal investigator, Jasper Clinic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797212
- Sponsor's protocol ID
- CTD-2008-19
- Status last verified
- Sep 2016
- First submitted
- 24 Nov 2008
- Last updated
- 3 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 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 Alternative Site Testing [Commercial Name is CONTOUR® USB]
- ClinicalTrials.gov ID
- NCT00797212
- Acronym / sponsor ID
- CTD-2008-19
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 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 14 Dec 2009
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 the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).
Detailed description
The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.
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 Apollo Blood Glucose Monitoring System with blood obtained from the palm and forearm |
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 years 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: Commercial name is CONTOUR® USBSubjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks. | Device | Subjects with diabetes |
Primary outcome
Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results
Time frame: One hour
Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP
2 secondary outcomes
Percentage of Participants Rated as <=3 (Labeling Comprehension)
Time frame: One hour
Percentage of Participant Ratings for Overall Testing Experience With This Meter
Time frame: One hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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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.
Vimala Sethy, MD, PhD principal investigator
Jasper Clinic, 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 3 Nov 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 14 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 AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results (time frame: One 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 3 Nov 2016.