Clinical trial NCT01711385: Undiagnosed Diabetes in a Dental Setting
Official title: Screening for Undiagnosed Diabetes in a Dental Setting - A New Paradigm for Dental Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Type 2 Diabetes Mellitus With Oral Complications
Periodontal Pocket
Tooth Loss
Keywords: Oral Health
Prediabetes
Diabetes
Periodontitis
Early Identification
Prevention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2012-10-22
Enrollment: 101
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 description: 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 set in motion far ranging, changes in the practice of dentistry, leading to the advancement of a new paradigm in dental practice that calls for the adoption of a more holistic approach to patient care.

Eligibility criteria: Inclusion Criteria:

* Patient who presents at the Columbia University College of Dental Medicine dental clinic
* Never been told that pre-diabetic or diabetic
* 40 years old or older, if white
* 30 years old or older, if non-white
* If female, not pregnant
* Not completely edentulous
* Able to undergo a periodontal examination

Exclusion Criteria:

* Previously told by physician that prediabetes or diabetes is present
* \< 40 years of age if non-hispanic and white, and \< 30 years of age if hispanic or non-white
* For medical or other reasons cannot tolerate a periodontal exam
* If female, pregnant
* Fully edentulous

Primary outcomes:
measure: Occurrence of follow-up visit to physician regarding screening result
timeFrame: Baseline up to six months
Secondary outcomes:
measure: Decrease in HbA1c
timeFrame: Baseline up to six months
measure: Improved periodontal measures
timeFrame: Baseline up to six months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University College of Dental Medicine
state: New York
Study officials:
affiliation: Columbia University College of Dental Medicine
name: Ira B. Lamster, DDS, M.M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: