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Undiagnosed Diabetes in a Dental Setting

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ClinicalTrials.gov Identifier: NCT01711385
Recruitment Status : Unknown
Verified October 2012 by Ira B. Lamster, Columbia University.
Recruitment status was:  Active, not recruiting
First Posted : October 22, 2012
Last Update Posted : October 22, 2012
Sponsor:
Collaborator:
Colgate Palmolive
Information provided by (Responsible Party):
Ira B. Lamster, Columbia University

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.

Condition or disease Intervention/treatment Phase
Prediabetic State Type 2 Diabetes Mellitus With Oral Complications Periodontal Pocket Tooth Loss Behavioral: Enhanced intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Screening for Undiagnosed Diabetes in a Dental Setting - A New Paradigm for Dental Practice
Study Start Date : April 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711385


Locations
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United States, New York
Columbia University College of Dental Medicine
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Colgate Palmolive
Investigators
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Principal Investigator: Ira B. Lamster, DDS, M.M.Sc. Columbia University College of Dental Medicine

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Responsible Party: Ira B. Lamster, Professor of Health Policy and Management and Dental Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01711385     History of Changes
Other Study ID Numbers: AAAD6446
First Posted: October 22, 2012    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012

Keywords provided by Ira B. Lamster, Columbia University:
Oral Health
Prediabetes
Diabetes
Periodontitis
Early Identification
Prevention

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Tooth Loss
Periodontal Pocket
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Periodontitis