Clinical Trial: Undiagnosed Diabetes in a Dental Setting

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Screening for Undiagnosed Diabetes in a Dental Setting - A New Paradigm for Dental Practice

Brief Summary: In an ongoing study new dental patients are screened to determine their risk of having undiagnosed pre-diabetes or diabetes based on risk factors readily known by the patient and signs of gum disease. Investigators further seek to assess if a post-identification intervention leads to a greater likelihood of study participants identified as potentially pre-diabetic or diabetic visiting their physician regarding their screening blood test results, and to improved health outcomes.

Detailed Summary:

Approximately 3% to 4% of the U.S. adult population has undiagnosed diabetes and the prevalence is likely to be substantially higher among people with risk factors for diabetes. Of note, many patients at the time of diagnosis of diabetes already have diabetic complications. This indicates that there is a period of "asymptomatic" diabetes during which hyperglycemia and other risk factors are present and complications are developing. This substantial delay in clinical diagnosis of diabetes involves a period of about 10-12 years that elapses between onset of diabetes and its diagnosis. Early diagnosis of diabetes, with treatment aiming at strict control of blood glucose levels, is important in preventing or mitigating its clinical complications and improving health outcomes.

Oral findings may offer an unrealized opportunity for the identification of affected individuals unaware of their condition. Previous research suggests that oral healthcare professionals have the opportunity to identify unrecognized diabetes and pre-diabetes in dental patients and refer them to a physician for further evaluation and care.

Based on these findings, efforts to identify dental patients' risk of having undiagnosed pre-diabetes or diabetes, using a new diagnostic blood test as the outcome (HPLC HbA1c), continue. In addition, a subgroup of study subjects identified as potentially pre-diabetic or diabetic are randomly assigned to either a group 1/basic-standard intervention arm or to a group 2/enhanced intervention arm. The investigators seek to determine if a post-identification intervention leads to a greater likelihood of study participants identified as potentially pre-diabetic or diabetic visiting their physician regarding their blood test results and to improved health outcomes. Results of this pilot study have the potential to se
Sponsor: Columbia University

Current Primary Outcome: Occurrence of follow-up visit to physician regarding screening result [ Time Frame: Baseline up to six months ]

Investigators want to determine if the enhanced intervention increases the likelihood that study participants identified as potentially pre-diabetic or diabetic visit their physician to discuss the screening results of their and to receive advice from their physician, relative to participants in the standard practice group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Decrease in HbA1c [ Time Frame: Baseline up to six months ]
    Investigators want to determine if study participants who receive the enhanced intervention have an improved HbA1c test result, relative to standard practice group participants, upon re-testing during a second study visit at 6 months.
  • Improved periodontal measures [ Time Frame: Baseline up to six months ]
    Investigators want to determine if the participants who receive the enhanced intervention are found to have improved periodontal findings, relative to standard practice group participants, upon re-examination during a second study visit at 6 months.


Original Secondary Outcome: Same as current

Information By: Columbia University

Dates:
Date Received: October 10, 2012
Date Started: April 2009
Date Completion: June 2013
Last Updated: October 18, 2012
Last Verified: October 2012