NCT06981286

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Aug 2025Jul 2027

First Submitted

Initial submission to the registry

April 7, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 30, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1.3 years

First QC Date

April 7, 2025

Last Update Submit

May 19, 2025

Conditions

Keywords

Oral HealthMachine LearningDiabetes Type 2

Outcome Measures

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

    12 months

Study Arms (2)

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

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

T2D

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Individuals with Diabetes type1

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Health, Blekinge Institute of Technology

Karlskrona, 37179, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Johan Flyborg, DDS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

May 20, 2025

Study Start

August 30, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Participant data can not be shared due to the GDPR.

Locations