- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06981286
- Original Trial
Oral Health Parameter-Based Diabetes Type 2 Indication Using Machine Learning (JFG)
May 19, 2025 updated by: Blekinge Institute of Technology
Oral Health Parameter-Based Diabetes Type 2 Indication Using Machine Learning in Older Individuals With Mild Cognitive Impairment
This study aims to explore the potential of using machine learning (ML) algorithms to predict Diabetes type2, based on oral health and demographic data.
The objective is to evaluate the effectiveness of various ML models and identify the most relevant oral health indicators for predicting type 2 diabetes in individuals with mild cognitive impairment aged 60 and above.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
This cross-sectional study utilizes oral health and demographic data from the Swedish National Study on Aging and Care (SNAC-B). Participants aged 60 years or older with Mild Cognitive Impairment will be included in the analysis. The data will be used to develop and evaluate machine learning models for predicting type 2 diabetes.
Objectives:
- Primary Objective: To assess the potential of oral health parameters for binary classification of type 2 diabetes or not.
- Secondary Objective: To identify the most influential oral health parameters contributing to type 2 diabetes predictions.
- Tertiary Objective: To compare the performance of Random Forest (RF), Support Vector Machine (SVM), and CatBoost (CB) classifiers in predicting type 2 diabetes using oral health data.
Study Type
Observational
Enrollment (Estimated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Johan Flyborg, DDS, PhD
- Phone Number: +46707283117
- Email: johan.flyborg@bth.se
Study Locations
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Karlskrona, Sweden, 37179
- Department of Health, Blekinge Institute of Technology
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Contact:
- Johan Flyborg
- Phone Number: 0707283117
- Email: johan.flyborg@bth.se
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Contact:
- Email: johan.flyborg@bth.se
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Principal Investigator:
- Johan Flyborg, DDS,PhD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Data collected from the Swedish National Study on Aging and Care (SNAC-B) will be analyzed.
Participants aged 60 years or older will be included in the analysis
Description
Inclusion Criteria:
- Individuals aged 60 years or older.
- Participants with recorded oral health parameters with or without Diabetes type2
Exclusion Criteria:
• Individuals with Diabetes type1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
T2D
Older individuals with Diabetes type 2
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A dataset comprising participants with T2D will be used to evaluate the classification performance of various machine-learning techniques.
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Group/Cohort Description: Older individuals without Diabetes type 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection perfomance
Time Frame: 12 months
|
Description: The study measures the classification performance of Machine Learning classifier.
Performance metrics, Accuracy, precision, recall, F1-Score and confusion matrix will be used for the evaluation.
The examination of the most important features relied on SHAP summary plots, providing visualizations of the influence of parameter groups on the output, organized by their importance.
This importance is based on SHAP values, offering insights into features' effects on the ML model's decision-making process
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 30, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
May 19, 2025
First Posted (Estimated)
May 20, 2025
Study Record Updates
Last Update Posted (Estimated)
May 20, 2025
Last Update Submitted That Met QC Criteria
May 19, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DT2 prediction
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Participant data can not be shared due to the GDPR.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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