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Not yet recruitingNCT06981286JFGUpdated May 20, 2025

Oral Health Parameter-Based Diabetes Type 2 Indication Using Machine Learning

An observational study in Type 2 Diabetes, sponsored by Blekinge Institute of Technology. Not yet recruiting at 1 site in Sweden. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-20.

Sponsored by Blekinge Institute of Technology · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
2,000
Ages
60 Years and older
Sex
All
01

Study summary

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.

Read the 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:

  1. Primary Objective: To assess the potential of oral health parameters for binary classification of type 2 diabetes or not.
  2. Secondary Objective: To identify the most influential oral health parameters contributing to type 2 diabetes predictions.
  3. 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.
02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Oral Health
  • Machine Learning
  • Diabetes Type 2
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Blekinge Institute of Technology is the lead sponsor of 14 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals aged 60 years or older.
  • Participants with recorded oral health parameters with or without Diabetes type2

Exclusion criteria

Exclusion Criteria:

  • Individuals with Diabetes type1
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • T2D

    Older individuals with Diabetes type 2

    Other: A dataset comprising participants withT2D will be used to evaluate the classification performance of various machine learning techniques.

  • Group/Cohort Description: Older individuals without Diabetes type 2

Interventions

  • OtherA dataset comprising participants withT2D will be used to evaluate the classification performance of various machine learning techniques.

    A dataset comprising participants with T2D will be used to evaluate the classification performance of various machine-learning techniques.

06

What researchers measure

Primary outcomes

  1. Detection perfomance

    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

    Time frame: 12 months

07

Study locations

1 site
  • Department of Health, Blekinge Institute of Technology
    Karlskrona, 37179, Sweden
08

References and documents

Individual participant data

Plan to share: No — Participant data can not be shared due to the GDPR.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2025; primary completion for Dec 2026, 16 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2025
First posted
May 20, 2025
StartEst.
Aug 30, 2025
Primary completionEst.
Dec 2026
CompletionEst.
Jul 2027
Last update
May 20, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06981286
Lead sponsor
Blekinge Institute of Technology
Responsible party
Sponsor
First posted
May 20, 2025
Start date
Aug 30, 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Jul 2027 (estimated)
Last update
May 20, 2025

Study contacts

Johan Flyborg, DDS, PhD
Contact
johan.flyborg@bth.se
+46707283117

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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