Undiagnosed Diabetes in a Dental Setting
Screening for Undiagnosed Diabetes in a Dental Setting - A New Paradigm for Dental Practice
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
-
New York
-
New York, New York, Соединенные Штаты, 10032
- Columbia University College of Dental Medicine
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Скрининг
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: 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.
|
|
|
Экспериментальный: 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.
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Occurrence of follow-up visit to physician regarding screening result
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Decrease in HbA1c
Временное ограничение: 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
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Ira B. Lamster, DDS, M.M.Sc., Columbia University College of Dental Medicine
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AAAD6446
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .