Undiagnosed Diabetes in a Dental Setting

NCT01711385 | Completed

• 1 other identifier: AAAD6446
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetic State; Type 2 Diabetes Mellitus With Oral Complications; Periodontal Pocket; Tooth Loss

Keywords

Oral Health; Prediabetes; Diabetes; Periodontitis; Early Identification; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Decrease in HbA1c

  Baseline up to six months

• Improved periodontal measures

  Baseline up to six months

Study Arms (2)

Standard practice

NO 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 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.

Enhanced intervention

EXPERIMENTAL

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

Interventions

Enhanced intervention BEHAVIORAL

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.

Enhanced intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Colgate Palmolive: collaborator

Study Sites (1)

Columbia University College of Dental Medicine

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Prediabetic State; Periodontal Pocket; Tooth Loss; Diabetes Mellitus; Periodontitis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Ira B. Lamster, DDS, M.M.Sc.

  Columbia University College of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 22, 2012
• Study Start: April 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

US (1)