DiabetesBGMSNCT01327209
Blood Glucose Monitoring System Clinical Study
An observational study of Diabetes, run by Intuity Medical, Inc at 4 sites in United States.
Trial summary
Verify the following with blood glucose monitoring system: precision and accuracy versus YSI reference user evaluation labeling comprehension Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Diabetes
- How many people
- 202 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People who have been diagnosed with diabetes and are testing their blood glucose level at least once per day.
Who may be able to join
- Be diagnosed with Diabetes
- Be between 12 and 70 years of age
- Be able to read, write, and understand English
- Be able and willing to give Informed Consent
- Have used an SMBG meter system for at least one year
- Be currently testing blood glucose levels at least once per day
Who cannot join
- Inability to provide Informed Consent
- Subject does not meet Inclusion Criteria
- Subject does not agree to test for infectious diseases per clinical protocol
- Subject has minimally one positive test for any infectious disease listed under Exclusion Criteria per protocol
- Subject with any condition (in addition to those which are listed in the pre-screen Exclusion Criteria tests) which in the opinion of the Investigator may place the subject or site personnel at excessive risk
- Subject's physical condition/limitation prevents the person from using a BGMS on their own
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Miami - School of Medicine
Miami, Florida, 33136
Park Nicollett Institute - International Diabetes Center
Minneapolis, Minnesota, 55416
Cetero Research DGD
San Antonio, Texas, 78229
University of San Diego
San Diego, California, 92161
About this study
Verify the following with blood glucose monitoring system:
- precision and accuracy versus YSI reference
- user evaluation
- labeling comprehension
- Conditions
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with diabetes | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2011 (estimated)
- Study startDec 2010
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuity Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Bergenstal, MD, Principal investigator, Park Nicollett Institue - International Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327209
- Sponsor's protocol ID
- TP-0000145
- Acronym
- BGMS
- Status last verified
- Jun 2011
- First submitted
- 30 Mar 2011
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Monitoring System Clinical Study
- ClinicalTrials.gov ID
- NCT01327209
- Acronym / sponsor ID
- BGMS / TP-0000145
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Intuity Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Study completion
- Apr 2011 (actual)
- First posted
- 1 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Verify the following with blood glucose monitoring system:
- precision and accuracy versus YSI reference
- user evaluation
- labeling comprehension
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with diabetes | – | – |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who have been diagnosed with diabetes and are testing their blood glucose level at least once per day.
Key inclusion criteria (6 listed)
- Be diagnosed with Diabetes
- Be between 12 and 70 years of age
- Be able to read, write, and understand English
- Be able and willing to give Informed Consent
- Have used an SMBG meter system for at least one year
Key exclusion criteria (6 listed)
- Inability to provide Informed Consent
- Subject does not meet Inclusion Criteria
- Subject does not agree to test for infectious diseases per clinical protocol
- Subject has minimally one positive test for any infectious disease listed under Exclusion Criteria per protocol
- Subject with any condition (in addition to those which are listed in the pre-screen Exclusion Criteria tests) which in the opinion of the Investigator may place the subject or site personnel at excessive risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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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.
Richard Bergenstal, MD principal investigator
Park Nicollett Institue - International Diabetes Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Intuity Medical, Inc 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 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 9 Jun 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 9 Jun 2011.