Blood Glucose Testing and You

A study testing Blood Glucose meter 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.

Trial summary

The purpose of this study is to determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes
What is being tested?: Blood Glucose meter
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 297 participants
Where: 2 sitesUnited States
Study dates: Oct 2011to Nov 2011
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females, 18 years of age and above
Type 2 diabetes
Able to speak, read, and understand English
Willing to complete all study procedures

Who cannot join

Type 1 diabetes
Currently a user of continuous glucose monitoring system
Currently pregnant
Hemophilia or any other bleeding disorder
Employee of competitive medical device company
Cognitive disorder or other condition which, in the opinion of the investigator (or designee), 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

TCOYD at San Diego Convention Center
San Diego, California, 92101
TCOYD Conference at Tampa Convention Center
Tampa, Florida, 33602-5331

Other trials in United States

About this study

The purpose of this study is to determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.

Conditions: Diabetes
Being tested: Blood Glucose meter
Medical subject headings: Diabetes Mellitus

What participants receive

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

Blood Glucose meterOther
Also called Contour® Blood Glucose Meter
Staff tested subject Blood Glucose using a Blood Glucose meter.

Study groups in NCT01453413
Study group	Role	What they receive
People with type 2 diabetes	Other	People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on a Blood Glucose meter, subjects were informed of their BG value. Receives: Other: Blood Glucose meter

What is being measured

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

Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®.
Measured: 1 visit 15-20 minutes

Secondary outcomes (1)

Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-15% different than meter BG values when samples have BG >=100 mg/dL or > +/- 15 mg/dL different than meter BG values when samples have BG <100 mg/dL, as measured by fingerstick CONTOUR®.
Measured: 1 visit 15-20 minutes

Timeline

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

Oct 2011Nov 2011

First posted17 Oct 2011 (estimated)
Study startOct 2011
Primary completionNov 2011
Study completionNov 2011

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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 297 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01453413
Sponsor's protocol ID: CTD PRO 2011-003-01
Status last verified: Feb 2013
First submitted: 30 Sep 2011
Last updated: 25 Feb 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pettus J, Stenger P, Schachner HC, Dunne N, Parkes JL, Pardo S, Edelman SV. Testing versus guessing blood glucose values: impact on self-care behaviors in type 2 diabetes. Curr Med Res Opin. 2014 Sep;30(9):1795-802. doi: 10.1185/03007995.2014.929097. Epub 2014 Jun 30.
PubMed 24889281

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

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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Glucose Testing and You
ClinicalTrials.gov ID: NCT01453413
Acronym / sponsor ID: CTD PRO 2011-003-01
Conditions: Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 297 participants (actual)
Lead sponsor: Ascensia Diabetes CareIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 17 Oct 2011 (estimated)
Results: Posted 17 Dec 2012

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 determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
People with type 2 diabetes	Other	Other: Blood Glucose meterPeople with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on a Blood Glucose meter, subjects were informed of their BG value.

Who may qualify

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

Key inclusion criteria (4 listed)

Males and females, 18 years of age and above
Type 2 diabetes
Able to speak, read, and understand English
Willing to complete all study procedures

Key exclusion criteria (6 listed)

Type 1 diabetes
Currently a user of continuous glucose monitoring system
Currently pregnant
Hemophilia or any other bleeding disorder
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
Blood Glucose meterAlso: Contour® Blood Glucose MeterStaff tested subject Blood Glucose using a Blood Glucose meter.	Other	People with type 2 diabetes

Primary outcome

Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
Time frame: 1 visit 15-20 minutes
The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®.

1 secondary outcome

Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose
Time frame: 1 visit 15-20 minutes

Results and safety

Results posted to the registry on 17 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
People With Type 2 Diabetes	297	297

Primary outcome: Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose

Time frame: 1 visit 15-20 minutes. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	People With Type 2 Diabetes n = 286
Value	45.80 (40.12 to 51.60)

Population analysed: Three subjects were excluded from analyses due to inconsistencies in responses to inclusion/exclusion questions(297-3=294). Eight subjects were excluded from BG analyses because they did not have both an estimated BG value and a meter result (294-8=286)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
People With Type 2 Diabetes	0 of 297 (0%)	3 of 297 (1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24889281Pettus J, Stenger P, Schachner HC, Dunne N, Parkes JL, Pardo S, Edelman SV. Testing versus guessing blood glucose values: impact on self-care behaviors in type 2 diabetes. Curr Med Res Opin. 2014 Sep;30(9):1795-802. doi: 10.1185/03007995.2014.929097. Epub 2014 Jun 30.

Related trials for Diabetes

Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes

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.

Steven Edelman, MD principal investigator

Founder TCOYD

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

Questions about this trial

What is this clinical trial studying?

A study testing Blood Glucose meter 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 4 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 25 Feb 2013. 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 17 Dec 2012). 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 Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose (time frame: 1 visit 15-20 minutes). 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 NCT01453413, 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 25 Feb 2013.