DiabetesNCT00985257

Performance of a New Glucose Meter System in Children and Young Adults

A study testing DIDGET (Investigational Blood Glucose Monitoring System) in people with Diabetes, run by Ascensia Diabetes Care at 2 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 of a new blood glucose meter in the hands of children, teens, young adults. Read more about this study

Who is it for?: Ages 4 to 24 years
Conditions the study is for: Diabetes
What is being tested?: DIDGET (Investigational Blood Glucose Monitoring System)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 2 sitesUnited States
Study dates: Sep 2009to Oct 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 or Type 2 diabetes
Age 4 to 24 years
Routinely performs blood glucose testing at home
If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.
Is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate

Who cannot join

Currently pregnant
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

2 sites in 1 country.

United States2 sites

AMCR Institute
Escondido, California, 92026
Larry C. Deeb, MD PA
Tallahassee, Florida, 32308

Other trials in United States

About this study

Official title: Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults

The purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.

Conditions: Diabetes
Being tested: DIDGET (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.

DIDGET (Investigational Blood Glucose Monitoring System)Device
Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.

Study groups in NCT00985257
Study group	Role	What they receive
Subjects with diabetes	Other	Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes. Receives: Device: DIDGET (Investigational Blood Glucose Monitoring System)

What is being measured

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

Percent of Blood Glucose (BG) 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 blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.
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.

Sep 2009Oct 2009

First posted28 Sep 2009 (estimated)
Study startSep 2009
Primary completionOct 2009
Study completionOct 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 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: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00985257
Sponsor's protocol ID: CTD-2009-35
Status last verified: Jan 2016
First submitted: 24 Sep 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?

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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: Performance of the DIDGET Blood Glucose Monitoring System in Children and Young Adults
ClinicalTrials.gov ID: NCT00985257
Acronym / sponsor ID: CTD-2009-35
Conditions: Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Ascensia Diabetes CareIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 28 Sep 2009 (estimated)
Results: Posted 2 Nov 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 of a new blood glucose meter in the hands of children, teens, young adults.

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: DIDGET (Investigational Blood Glucose Monitoring System)Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.

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 or Type 2 diabetes
Age 4 to 24 years
Routinely performs blood glucose testing at home
If age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand English.
If younger than age 18, subject's parent/guardian must be able to speak, read, and understand English, and is able to provide appropriate supervision.

Key exclusion criteria (6 listed)

Currently pregnant
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

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
DIDGET (Investigational Blood Glucose Monitoring System)Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.	Device	Subjects with diabetes

Primary outcome

Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method
Time frame: 1-2 hours
Subjects with diabetes and healthcare professionals (HCPs) used a new blood glucose monitoring system (BGMS) with subject blood. BGM results were compared to a lab glucose method - Yellow Springs Instrument (YSI) Analyzer. Duplicate BG results were used to calculate the number of BG results within +/-15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG values >/=75mg/dL) of the reference method results.

Results and safety

Results posted to the registry on 2 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
Subjects With Diabetes	123	123

Primary outcome: Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method

Time frame: 1-2 hours. Number. Unit: percent of blood glucose results

Measure	Subjects With Diabetes n = 121
Subject Tests Natural Capillary n=242=2 x 121	97.1
Combine Natural+Modified n=336=2 x (121+47)	97.9

Population analysed: To achieve glucose concentrations across the meter test range, 47 blood samples were modified. The total glucose distribution (total 121 natural capillary samples plus 47 modified) ranged from 25.7 to 563.5mg/dL. Two sets of subject results were not analyzed because sufficient sample was not obtained for the YSI reference test.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With Diabetes	0 of 123 (0%)	0 of 123 (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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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

Larry C Deeb, MD PA principal investigator

Larry C. Deeb, MD PA

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

Questions about this trial

What is this clinical trial studying?

A study testing DIDGET (Investigational Blood Glucose Monitoring System) in people with Diabetes, run by Ascensia Diabetes Care at 2 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 6 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 2 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 2 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?

Percent of Blood Glucose (BG) Results Within +/-15mg/dL or +/-20% of Laboratory Glucose Method (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 NCT00985257.

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.