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Undiagnosed Diabetes in a Dental Setting

13. august 2021 opdateret af: Columbia University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

101

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University College of Dental Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Eksperimentel: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of follow-up visit to physician regarding screening result
Tidsramme: 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.
Baseline up to six months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decrease in HbA1c
Tidsramme: 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.
Baseline up to six months
Improved periodontal measures
Tidsramme: 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.
Baseline up to six months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Columbia University

Samarbejdspartnere

Colgate Palmolive

Efterforskere

  • Ledende efterforsker: Ira B. Lamster, DDS, M.M.Sc., Columbia University College of Dental Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2009

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

10. oktober 2012

Først indsendt, der opfyldte QC-kriterier

18. oktober 2012

Først opslået (Skøn)

22. oktober 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AAAD6446

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Prædiabetisk tilstand

Kliniske forsøg med Enhanced intervention

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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CROs in United Kingdom

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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