NCT07336459

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of an AI-driven multimodal rehabilitation framework combining digital health technologies, intermittent fasting, and resistance training in individuals with Type 2 Diabetes Mellitus (T2DM). The study will integrate mobile-based AI monitoring for glucose trends, physical activity tracking, and dietary adherence reminders, thereby improving patient engagement and self-management.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress54%
Apr 2025Mar 2027

Study Start

First participant enrolled

April 17, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

November 21, 2025

Last Update Submit

January 12, 2026

Conditions

Type 2 Diabetes Mellitus 1

Outcome Measures

Primary Outcomes (5)

  • HbA1c (Biochemical Outcome)

    HbA1c will be assessed from venous blood and reported as a percentage (%).

    24 Months

  • HOMA-IR (Biochemical Outcome)

    HOMA-IR will be derived from fasting glucose and fasting insulin measurements and presented as a unitless index.

    24 Months

  • 6-Minute Walk Test (Functional capacity; distance in meters)

    The 6-Minute Walk Test (6MWT) measures functional capacity by recording the total distance (in meters) a person can walk in six minutes on a flat, straight course. Healthy adults typically walk between 400 and 700 meters,

    24 Months

  • WHOQOL-BREF

    The WHOQOL-BREF is a 26-item, self-report questionnaire developed by the World Health Organization (WHO) for measuring an individual's self-perceived quality of life. It is a widely used and cross-culturally validated abbreviated version of the original, more comprehensive WHOQOL-Score 0-100

    24 Months

  • Diabetes Self-Management Questionnaire

    Diabetes Self-Management Questionnaire (DSMQ), first reverse the scores for any negatively worded items so higher scores consistently indicate more effective self-care. Then, sum the scores for all items to get a raw total score. This raw score can be transformed to a scale of 0-10 by dividing the raw score by the theoretical maximum and multiplying by 10 for easier interpretation and comparison.

    24 Months

Study Arms (2)

AI-Guided Multimodal Rehabilitation Program

EXPERIMENTAL
Combination Product: AI-Guided Multimodal Rehabilitation Program

Standard Diabetes Care

ACTIVE COMPARATOR
Diagnostic Test: Standard Diabetes Care

Interventions

AI-Guided Multimodal Rehabilitation ProgramCOMBINATION_PRODUCT

Digital Health: Mobile AI-based app with glucose tracking, exercise reminders, and fasting compliance monitoring Intermittent Fasting: 16:8 time-restricted feeding protocol, 5 days/week Resistance Training: 3 sessions/week (45 minutes), supervised + home-based program using elastic bands \& bodyweight

AI-Guided Multimodal Rehabilitation Program
Standard Diabetes CareDIAGNOSTIC_TEST

Usual pharmacological treatment + general lifestyle advice No structured AI, fasting, or exercise protocol

Standard Diabetes Care

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Type 2 Diabetes (≥1 year)
  • HbA1c between 6.5% and 9.0%
  • Sedentary or low physical activity levels
  • BMI: 25-35 kg/m²
  • Able to perform mild-to-moderate exercise

You may not qualify if:

  • any other disability
  • not willing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Superior University CRC

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Noninsulin-Dependent, 1

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 13, 2026

Study Start

April 17, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)