Diabetes MellitusNCT01201460
DPBRN Blood Sugar Testing in Dental Patients
An observational study of Diabetes Mellitus and Hyperglycemia, run by Dental Practice-Based Research Network at 7 sites in 2 countries.
Trial summary
The principal goal of this study was to assess the feasibility of plasma glucose testing in private dental practice. A second aim was was to assess prevalence of plasma glucose abnormalities in dental patients seen by (DPBRN) practitioner-investigators. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hyperglycemia
- How many people
- 498 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Apr 2009to Jul 2010
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The human subjects direclty involved in this study were the patients who had sought dental treatment in the (DPBRN) practitioner-investigators' practices.
Who may be able to join
- adults over the age of 19 who were scheduled for a visit with an exam
Who cannot join
- patients undergoing continuing treatment where an exam was not part of the visit were not eligible
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Florida College of Dentistry
Gainesville, Florida, 32610
Health Partners Dental Group
Minneapolis, Minnesota, 55440-1309
Health Partners Research Foundation
Minneapolis, Minnesota, 55440-1524
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Permanente Denrtal Associates
Portland, Oregon, 97232
About this study
Official title: Blood Sugar Testing in Dental Patients
The principal goal of this study was to assess the feasibility of plasma glucose testing in private dental practice. A second aim was was to assess prevalence of plasma glucose abnormalities in dental patients seen by (DPBRN) practitioner-investigators.
Read the detailed description
The specific aims of this study were:
- To quantify the percentage of (DPBRN) patients who meet the American Diabetes Association screening criteria and to describe the characteristics of these patients.
- To quantify the acceptability of conducting glucose testing in the dental office and barriers to regular screening, as reported by (DPBRN) patients and practices.
- Conditions
- Diabetes Mellitus, Hyperglycemia
- Keywords
- glucose testing
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
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 |
|---|---|---|
| Glucose testing | Patients participating in this study may be alerted to possible presence of (DM) or pre-(DM) or to inadequate glycemic control. In such a case, they were advised to follow-up with their physician for definitive diagnosis and treatment. Early diagnosis and improved glycemic control may be of significant benefit to the patients' health. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startApr 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon
- Investigators
- Andrei Barasch, DMD, MDSc, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201460
- Sponsor's protocol ID
- 123961
- Other IDs
- U01DE016747
- Status last verified
- Jun 2011
- First submitted
- 13 Sep 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Sugar Testing in Dental Patients
- ClinicalTrials.gov ID
- NCT01201460
- Acronym / sponsor ID
- 123961
- Conditions
- Diabetes Mellitus, Hyperglycemia
- Keywords
- glucose testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon
- Study start
- Apr 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Sep 2010 (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.
The principal goal of this study was to assess the feasibility of plasma glucose testing in private dental practice. A second aim was was to assess prevalence of plasma glucose abnormalities in dental patients seen by (DPBRN) practitioner-investigators.
Detailed description
The specific aims of this study were:
- To quantify the percentage of (DPBRN) patients who meet the American Diabetes Association screening criteria and to describe the characteristics of these patients.
- To quantify the acceptability of conducting glucose testing in the dental office and barriers to regular screening, as reported by (DPBRN) patients and practices.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glucose testing | – | –Patients participating in this study may be alerted to possible presence of (DM) or pre-(DM) or to inadequate glycemic control. In such a case, they were advised to follow-up with their physician for definitive diagnosis and treatment. Early diagnosis and improved glycemic control may be of significant benefit to the patients' health. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The human subjects direclty involved in this study were the patients who had sought dental treatment in the (DPBRN) practitioner-investigators' practices.
Key inclusion criteria (1 listed)
- adults over the age of 19 who were scheduled for a visit with an exam
Key exclusion criteria (1 listed)
- patients undergoing continuing treatment where an exam was not part of the visit were not eligible
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 16 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.
Andrei Barasch, DMD, MDSc principal investigator
The University of Alabama at Birmingham
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hyperglycemia, run by Dental Practice-Based Research Network at 7 sites in 2 countries.
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 1 inclusion and 1 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 16 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 7 sites in United States, Denmark. 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 16 Jun 2011.