Type 2 Diabetes Mellitus 1NCT07336459
AI-Driven MRF Type 2 Diabetes Integrating DHT IF and Resistance Training to OM and Functional Outcomes
A study testing AI-Guided Multimodal Rehabilitation Program and Standard Diabetes Care in people with Type 2 Diabetes Mellitus 1, run by Superior University at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus 1
- What is being tested?
- AI-Guided Multimodal Rehabilitation Program and Standard Diabetes Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- any other disability
- not willing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AI-Driven Multimodal Rehabilitation Framework for Type 2 Diabetes Integrating Digital Health Technologies, Intermittent Fasting, and Resistance Training to Optimize Metabolic and Functional Outcomes
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus 1
- Being tested
- AI-Guided Multimodal Rehabilitation Program, Standard Diabetes Care
- Medical subject headings
- Diabetes Mellitus, Noninsulin-Dependent, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Standard Diabetes CareDiagnostic test
Usual pharmacological treatment + general lifestyle advice No structured AI, fasting, or exercise protocol
| Study group | Role | What they receive |
|---|---|---|
| AI-Guided Multimodal Rehabilitation Program | Experimental | Not described Receives: Combination Product: AI-Guided Multimodal Rehabilitation Program |
| Standard Diabetes Care | Active comparator | Not described Receives: Diagnostic Test: Standard Diabetes Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c (Biochemical Outcome)
HbA1c will be assessed from venous blood and reported as a percentage (%).
Measured: 24 Months
HOMA-IR (Biochemical Outcome)
HOMA-IR will be derived from fasting glucose and fasting insulin measurements and presented as a unitless index.
Measured: 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,
Measured: 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
Measured: 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.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336459
- Sponsor's protocol ID
- PhDRSW/Batch-Fall23/2228
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Driven Multimodal Rehabilitation Framework for Type 2 Diabetes Integrating Digital Health Technologies, Intermittent Fasting, and Resistance Training to Optimize Metabolic and Functional Outcomes
- ClinicalTrials.gov ID
- NCT07336459
- Acronym / sponsor ID
- PhDRSW/Batch-Fall23/2228
- Conditions
- Type 2 Diabetes Mellitus 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Guided Multimodal Rehabilitation Program | Experimental | Combination Product: AI-Guided Multimodal Rehabilitation Program |
| Standard Diabetes Care | Active comparator | Diagnostic Test: Standard Diabetes Care |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- any other disability
- not willing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Guided Multimodal Rehabilitation ProgramDigital 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 | Combination product | AI-Guided Multimodal Rehabilitation Program |
| Standard Diabetes CareUsual pharmacological treatment + general lifestyle advice No structured AI, fasting, or exercise protocol | Diagnostic test | Standard Diabetes Care |
Primary outcome
HbA1c (Biochemical Outcome)
Time frame: 24 Months
HbA1c will be assessed from venous blood and reported as a percentage (%).
HOMA-IR (Biochemical Outcome)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Guided Multimodal Rehabilitation Program and Standard Diabetes Care in people with Type 2 Diabetes Mellitus 1, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (Biochemical Outcome) (time frame: 24 Months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.