An Active Health-Based Comprehensive Study on Diabetes Management

NCT07160998 | Completed DMC

• 1 other identifier: 2025-122
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Time in Range (TIR, %)

  Percentage of glucose readings within 3.9-10 mmol/L measured by CGM

  Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28)

Secondary Outcomes (20)

• Other CGM metrics

  Run-in period (Day -7 to Day 0) and intervention period (Day 1 to Day 28)

• Patient-reported outcomes

  Baseline and 28 days

• User Experience Score

  At 28 days

• Safety outcomes

  Day 1-28 (intervention period)

• OGTT Glucose Concentration

  Baseline and 28 days

Study Arms (2)

X Life AI Lifestyle Guidance

EXPERIMENTAL

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

Other: Digital Lifestyle Therapeutic

Standard Care

ACTIVE COMPARATOR

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

Behavioral: Standard Care

Interventions

Digital Lifestyle Therapeutic OTHER

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

X Life AI Lifestyle Guidance

Standard Care BEHAVIORAL

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

Standard Care

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Li Huating: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai 6th People's Hospital

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 8, 2025
• Study Start: September 7, 2025
• Primary Completion: November 28, 2025
• Study Completion: December 6, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

CN (1)