An Active Health-Based Comprehensive Study on Diabetes Management

NCT ID: NCT07160998

Last Updated: 2026-02-12

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

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-07

Study Completion Date

2025-12-06

Brief Summary

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This randomized, open-label, multicenter trial evaluates the efficacy and safety of the AI-based lifestyle guidance system (X-Life) compared to standard care in adults with type 2 diabetes. X-Life integrates glucose level, wearable devices, and AI-driven decision models to provide personalized lifestyle recommendations. The primary endpoint is the percentage of time in glucose target range (TIR).

Detailed Description

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Type 2 diabetes imposes a global health burden. Traditional care has limitations in accessibility, personalization, and long-term adherence. AI-driven digital therapeutics may overcome these barriers. X-Life is an innovative AI system providing individualized lifestyle guidance using glucose level and wearable data. User studies demonstrated usability and acceptability. This multicenter randomized controlled trial will rigorously test whether X-Life improves glycemic control compared with standard care, while also evaluating metabolic outcomes, patient-reported measures, and safety. The investigators designed this trial with the assistance of a digital twin-based clinical research system (termed X Town).

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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X Life AI Lifestyle Guidance

Personalized real-time lifestyle recommendations delivered via smartphone, tablet, etc., integrating glucose level and wearable data.

Group Type EXPERIMENTAL

Digital Lifestyle Therapeutic

Intervention Type OTHER

Personalized real-time lifestyle recommendations are delivered via via smartphone, tablet, etc., integrating glucose level and wearable data.

Standard Care

Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines.

Interventions

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Digital Lifestyle Therapeutic

Personalized real-time lifestyle recommendations are delivered via via smartphone, tablet, etc., integrating glucose level and wearable data.

Intervention Type OTHER

Standard Care

Participants receive standard diabetes management including medications and lifestyle recommendations based on guidelines.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18-70 years
* Diagnosed type 2 diabetes
* Stable medication regimen ≥ 3 months
* HbA1c 7-10%
* Smartphone access and ability to operate app
* Willing to wear CGM and activity tracker
* Able to provide informed consent

Exclusion Criteria

* Insulin therapy
* Severe chronic/acute diabetic complications
* Early-onset diabetes (\<40 years at diagnosis)
* Severe cardiovascular disease, uncontrolled hypertension, active liver disease, malignancy
* Severe psychiatric or cognitive disorders
* Allergy to CGM materials
* Planned surgery or long-term travel during study
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Li Huating

OTHER

Sponsor Role lead

Responsible Party

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Li Huating

Shanghai 6th People's Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai Sixth People's Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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2025-122

Identifier Type: -

Identifier Source: org_study_id

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