Type 2 Diabetes Mellitus 1
Conditions
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.
Detailed description
Participants will be randomized into two groups: the intervention group receiving AI-guided resistance training alongside intermittent fasting, and the control group receiving standard diabetes care. Outcomes will include changes in HbA1c, insulin sensitivity (HOMA-IR), muscle strength, functional mobility, and quality of life. The study will also assess adherence, feasibility, and cost-effectiveness. By utilizing AI-enabled technology and lifestyle-based interventions, this study addresses the gap between clinical management and sustainable self-care in T2DM. The framework is designed to be low-cost, scalable, and adaptable, making it suitable for resource-limited healthcare systems.
Interventions
COMBINATION_PRODUCTAI-Guided Multimodal Rehabilitation Program
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
DIAGNOSTIC_TESTStandard Diabetes Care
Usual pharmacological treatment + general lifestyle advice No structured AI, fasting, or exercise protocol
Sponsors
Superior University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* any other disability * not willing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (Biochemical Outcome) | 24 Months | HbA1c will be assessed from venous blood and reported as a percentage (%). |
| HOMA-IR (Biochemical Outcome) | 24 Months | HOMA-IR will be derived from fasting glucose and fasting insulin measurements and presented as a unitless index. |
| 6-Minute Walk Test (Functional capacity; distance in meters) | 24 Months | 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, |
| WHOQOL-BREF | 24 Months | 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 |
| Diabetes Self-Management Questionnaire | 24 Months | 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. |
Countries
Pakistan
Outcome results
None listed