Undiagnosed Diabetes in a Dental Setting

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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetic State; Tooth Loss; Periodontal Pocket; Type 2 Diabetes Mellitus With Oral Complications
• Intervention / Treatment: Behavioral: Enhanced intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University College of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard practice; Study patients are notified of their "diagnostic" test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the basic/control intervention, are informed that it is important to follow-up with their physician regarding their test results. They are contacted by phone once to schedule their 6-month recall visit.
Experimental: Enhanced intervention; Study patients are notified of their "diagnostic" test result within 72 hours. Those identified as potentially pre-diabetic or diabetic and randomized to the enhanced group, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results. They are given a letter to take to their physician and receive a call at month two and then again at month four if necessary to inquire if they have followed-up with their physician and encouragement to do so, if they have not, prior to their six month follow-up study visit.	Behavioral: Enhanced intervention; Study patients are notified of their blood test result within 72 hours. Those identified as potentially pre-diabetic or diabetic, and randomized to the enhanced intervention arm, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results or are provided with a referral to one. They are given a letter to take to their physician that specifies the risk factors identified, the tests carried out for the patient and the exact numeric results. They receive a call at month 2 to see if they have followed up with a physician regarding their test results. If they have not seen a physician regarding their results, they are advised again to do so and reminded of their individual risk factors. At month 4 they are asked again if they have seen a physician regarding their test results. If they still have not seen a physician at this time the message is reinforced. They are contacted again by phone to schedule the 6-month recall visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of follow-up visit to physician regarding screening result	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.	Baseline up to six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in HbA1c	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.	Baseline up to six months
Improved periodontal measures	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.	Baseline up to six months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Colgate Palmolive
• Investigators: Principal Investigator: Ira B. Lamster, DDS, M.M.Sc., Columbia University College of Dental Medicine

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; Prediabetes; Prevention; Periodontitis; Oral Health; Early Identification
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Tooth Loss; Periodontal Pocket
• Other Study ID Numbers: AAAD6446