Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation

NCT ID: NCT06469658

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-02

Study Completion Date

2024-06-03

Brief Summary

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This randomized controlled trial investigates the effectiveness of AI-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing Type 2 diabetes (T2D). The study includes 160 participants with T2D, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the AI-guided group (prescriptions determined by GenAIS, an AI system by Triangel Scientific). The primary objective is to compare the reduction in HbA1c levels between the two groups over 6 months. Secondary outcomes include changes in fasting glucose, lipid profiles, body weight, BMI, hsCRP levels, and adherence to the dietary supplement regimen. The AI system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1

Group Type ACTIVE_COMPARATOR

The standard practice dietary supplements intervention

Intervention Type OTHER

Participants receive supplements prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.

Group 2

Group Type EXPERIMENTAL

The AI-guided practice dietary supplements group

Intervention Type OTHER

Participants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Interventions

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The standard practice dietary supplements intervention

Participants receive supplements prescriptions from a physician based on current standard practices, which include biochemical markers, genetic data, and metabolic profiles.

Intervention Type OTHER

The AI-guided practice dietary supplements group

Participants receive DS prescriptions determined by GenAIS, an AI system which considers genetic data, metabolic profiles, biochemical markers, and patient history.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 40 and 75 years.
* Diagnosed with Type 2 diabetes (HbA1c between 7.0% and 10.0%).
* Stable anti-diabetic medication regimen for at least 3 months prior to the study.
* Willingness to provide genetic and metabolic data.

Exclusion Criteria

* Type 1 diabetes or other specific types of diabetes.
* Significant renal, hepatic, or cardiovascular diseases.
* Use of dietary supplements that affect glucose metabolism within the last 3 months.
* Pregnancy or breastfeeding
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Triangel Scientific

INDUSTRY

Sponsor Role collaborator

Center of New Medical Technologies

OTHER

Sponsor Role collaborator

S.LAB (SOLOWAYS)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia

Site Status

Countries

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Russia

Other Identifiers

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SW014

Identifier Type: -

Identifier Source: org_study_id

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