Type 1 Diabetes Mellitus (T1DM)GlycoQuestNCT07726680
GlycoQuest: An AI-Adaptive CGM-Integrated Serious Game for Pediatric Type 1 Diabetes
A study testing GlycoQuest Digital Therapeutic and Enhanced Digital Psychoeducation in people with Type 1 Diabetes Mellitus (T1DM) and Diabetes Distress, run by Shifa International Hospital at 1 site in Pakistan.
Trial summary
Type 1 diabetes diagnosed in childhood requires rapid acquisition of complex self-management skills while children and caregivers are also adapting emotionally and socially to a chronic condition. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus (T1DM), Diabetes Distress, Hypoglycemia (Diabetic)
- What is being tested?
- GlycoQuest Digital Therapeutic and Enhanced Digital Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 30 Nov 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child or adolescent aged 6 to 17 years at enrollment.
- Diagnosis of type 1 diabetes confirmed by a pediatric endocrinologist according to standard clinical criteria.
- Type 1 diabetes diagnosed within the previous 3 months.
- Primary caregiver aged 18 years or older willing to participate as part of a parent-child dyad.
- Current use of continuous glucose monitoring or willingness to initiate CGM as part of standard diabetes care.
- Household access to a compatible smartphone or tablet, or willingness to use a study-provided device if available.
Show all 9Show fewer
- Ability of child and caregiver to engage with study procedures and digital intervention content.
- Caregiver able to provide written informed consent.
- Child able to provide age-appropriate assent.
Who cannot join
- Type 1 diabetes diagnosed more than 3 months before enrollment.
- Concurrent participation in another intensive diabetes behavioral intervention trial.
- Significant developmental, intellectual, visual, motor, or psychiatric condition that, in the opinion of the clinical team, would preclude meaningful engagement with the digital game interface or study procedures.
- Acute psychiatric instability or safety concern requiring urgent specialist intervention.
- Planned transfer to a different diabetes care provider within 6 months.
- Absence of internet access that cannot be addressed by study support.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shifa International hospital
Lahore, Punjab Province
Saima Abbass, MD, PhD, 00923206503200, saimaabasstahammal@gmail.com
About this study
Official title: GlycoQuest: Glycemic and Psychosocial Outcomes of a CGM-Integrated, AI-Adaptive Serious Game Digital Therapeutic in Newly Diagnosed Pediatric Type 1 Diabetes: A Parallel-Group Randomized Controlled Trial
Type 1 diabetes diagnosed in childhood requires rapid acquisition of complex self-management skills while children and caregivers are also adapting emotionally and socially to a chronic condition. Standard diabetes education is often delivered early after diagnosis, is information intensive, and is not usually personalized to real-time glucose patterns, emotional state, child developmental stage, or family communication needs.
This study will evaluate GlycoQuest, an AI-adaptive, continuous glucose monitoring-integrated serious game digital therapeutic for children and adolescents newly diagnosed with type 1 diabetes and their primary caregivers. GlycoQuest uses CGM-linked gameplay, a glucose-responsive digital avatar, AI-personalized learning pathways, parent-child collaborative modules, adaptive hypoglycemia and insulin decision simulations, and psychosocial adaptation content addressing diabetes distress, fear of hypoglycemia, stigma, illness acceptance, and autonomy transition.
This randomized controlled trial will enroll 110 parent-child dyads. Children aged 6 to 17 years with type 1 diabetes diagnosed within the previous 3 months will be randomized 1:1 to GlycoQuest plus standard care or enhanced digital psychoeducation plus standard care. The intervention period will be 6 months, with follow-up to 8 months. The co-primary outcomes are change in CGM-derived time in range, defined as 70 to 180 mg/dL, and child diabetes distress at 8 months. Secondary outcomes include time below range, glycemic variability, HbA1c, severe hypoglycemia, diabetic ketoacidosis readmissions, insulin omission, quality of life, fear of hypoglycemia, parental stress, diabetes family conflict, self-efficacy, engagement, and implementation outcomes.
Read the detailed description
GlycoQuest is a precision behavioral digital therapeutic designed for children and adolescents newly diagnosed with type 1 diabetes and their caregivers. The intervention integrates continuous glucose monitoring data, AI-driven personalization, serious game mechanics, behavioral science, and family-centered psychosocial support. The study is designed to test whether a CGM-linked adaptive game can improve glycemic outcomes and psychosocial adaptation during the critical first year after diagnosis.
The game is structured as a narrative role-playing environment in which the child's avatar responds to real-world glucose patterns. CGM-derived glucose trends influence in-game state, quest allocation, feedback, and reinforcement. The platform includes modules on CGM interpretation, insulin safety, carbohydrate estimation, hypoglycemia recognition and treatment, sick-day decision-making, school and peer interactions, stigma, illness acceptance, and gradual transfer of diabetes responsibility. Parent-child collaborative gameplay modules address communication, shared problem solving, caregiver fear of hypoglycemia, child autonomy, and diabetes-related family conflict.
The AI personalization engine adapts game content using multiple signal streams, including CGM patterns, engagement behavior, in-game decision errors, literacy and comprehension markers, and brief emotional check-ins. The system classifies recurring self-management challenges and delivers personalized gameplay, simulations, repetition, caregiver prompts, and psychosocial support. The platform does not provide autonomous insulin dosing advice and does not replace clinical care. Safety-critical content is governed by clinician-approved rules, and families remain under the care of their usual pediatric diabetes team.
Participants will be randomized to GlycoQuest plus standard care or enhanced digital psychoeducation plus standard care. The comparator is a professionally designed digital education app containing diabetes education materials matched for content coverage but without AI personalization, CGM-linked gameplay, adaptive algorithms, serious game mechanics, or parent-child co-play. The primary follow-up time point is 6 months, with extended follow-up at 8 months to assess durability, safety, engagement, and implementation outcomes.
- Conditions
- Type 1 Diabetes Mellitus (T1DM), Diabetes Distress, Hypoglycemia (Diabetic), Family Conflict
- Being tested
- GlycoQuest Digital Therapeutic, Enhanced Digital Psychoeducation
- Keywords
- Type 1 Diabetes, Pediatric Diabetes, Continuous Glucose Monitoring, Digital Therapeutic, Serious Game, Artificial Intelligence, Diabetes Distress, Fear of Hypoglycemia, Family-Centered Care, Behavioral Medicine, Time in Range, Self-Efficacy, Implementation Science
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycoQuest Digital TherapeuticBehavioural
GlycoQuest is an AI-adaptive, CGM-integrated serious game digital therapeutic designed for children and adolescents newly diagnosed with type 1 diabetes and their caregivers. The intervention includes real-time CGM-linked gameplay, a glucose-responsive digital avatar, AI-personalized content allocation, adaptive insulin and hypoglycemia decision simulations, parent-child collaborative missions, spaced repetition, reward-based learning, self-efficacy reinforcement, and psychosocial adaptation modules addressing diabetes distress, fear of hypoglycemia, stigma, illness acceptance, and autonomy transition. GlycoQuest does not provide autonomous insulin dosing recommendations and does not replace clinical care.
Enhanced Digital PsychoeducationBehavioural
Enhanced Digital Psychoeducation is a study-branded digital education app providing structured diabetes education content for children, adolescents, and caregivers. It includes educational modules, illustrations, videos, glossary functions, and links to validated diabetes resources. The comparator does not include AI personalization, CGM-linked gameplay, serious game mechanics, adaptive algorithms, digital twin functions, or parent-child co-play modules.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: GlycoQuest Digital Therapeutic | Experimental | Participants randomized to this arm will receive GlycoQuest in addition to standard pediatric diabetes care. GlycoQuest is an AI-adaptive, CGM-integrated serious game digital therapeutic for children and adolescents newly diagnosed with type 1 diabetes and their caregivers. The platform uses CGM-linked gameplay, a glucose-responsive digital avatar, AI-personalized learning pathways, parent-child collaborative modules, adaptive hypoglycemia and insulin decision simulations, and psychosocial adaptation content. The intervention is delivered over 6 months, with follow-up to 8 months. Receives: Behavioral: GlycoQuest Digital Therapeutic |
| Enhanced Digital Psychoeducation | Active comparator | Participants randomized to this arm will receive enhanced digital psychoeducation in addition to standard pediatric diabetes care. The comparator consists of a professionally designed digital library of diabetes education materials, including text, illustrations, videos, glossary functions, and links to validated diabetes resources. It is matched to GlycoQuest for general content coverage but does not include serious game mechanics, AI personalization, CGM-linked gameplay, adaptive algorithms, or parent-child co-play features. Receives: Behavioral: Enhanced Digital Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CGM-Derived Time in Range at 8 Months
Change from baseline to 8 months in the percentage of time spent in the glucose target range of 70 to 180 mg/dL, measured using continuous glucose monitoring data.
Measured: Baseline to 8 months
Secondary outcomes (8)
Change in Pediatric Diabetes Distress at 8 Months
Change from baseline to 8 months in child-reported diabetes distress, measured using the study-developed GlycoQuest Pediatric Diabetes Distress Questionnaire. Total scores range from 0 to 40, with higher scores indicating greater diabetes distress.
Measured: Baseline to 8 months
Change in CGM-Derived Time Below 70 mg/dL
Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose below 70 mg/dL.
Measured: Baseline to 8 months
Change in CGM-Derived Time Above 180 mg/dL
Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose above 180 mg/dL.
Measured: Baseline to 8 months
Change in CGM-Derived Glucose Coefficient of Variation
Change from baseline to 8 months in glucose coefficient of variation, calculated from continuous glucose monitoring values as the standard deviation of glucose divided by mean glucose, multiplied by 100. Values are expressed as a percentage, with higher values indicating greater glycemic variability.
Measured: Baseline to 8 months
Change in HbA1c
Change from baseline in glycated hemoglobin A1c (HbA1c), measured in percentage points, at 6 months and 8 months.
Measured: Baseline, 6 and 8 months
Number of Severe Hypoglycemia Events
Number of severe hypoglycemia events requiring assistance from another person during the 8-month study period. Higher values indicate a greater number of severe hypoglycemia events.
Measured: Baseline to 8 months
Change in CGM-Derived Time Below 54 mg/dL
Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose below 54 mg/dL.
Measured: Baseline to 8 months
Change in CGM-Derived Time Above 250 mg/dL
Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose above 250 mg/dL.
Measured: Baseline to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus (T1DM)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized individually in a 1:1 ratio to either GlycoQuest plus standard diabetes care or enhanced digital psychoeducation plus standard diabetes care. Both groups will be followed for 8 months, with the primary endpoint assessed at 6 months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa International Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Al Ain University
- Responsible party
- Principal investigator, Saima Abass Tahammal, Shifa International Hospital
- Investigators
- Saima Abbass, MD, PhD, Study director, Shifal hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726680
- Sponsor's protocol ID
- SH-34988971
- Other IDs
- SIAC-02907, GlycoQuest
- Acronym
- GlycoQuest
- Status last verified
- Jul 2026
- First submitted
- 26 May 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published primary results will be made available after publication, subject to ethics approval, institutional data-sharing agreements, and protection of participant privacy. Shared data may include de-identified clinical outcomes, CGM-derived outcome metrics, questionnaire scores, and intervention engagement variables. Data that could reasonably identify child participants or families, including raw high-resolution CGM streams linked to timestamps or free-text responses, will not be shared without additional safeguards.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GlycoQuest: Glycemic and Psychosocial Outcomes of a CGM-Integrated, AI-Adaptive Serious Game Digital Therapeutic in Newly Diagnosed Pediatric Type 1 Diabetes: A Parallel-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07726680
- Acronym / sponsor ID
- GlycoQuest / SH-34988971
- Conditions
- Type 1 Diabetes Mellitus (T1DM), Diabetes Distress, Hypoglycemia (Diabetic), Family Conflict
- Keywords
- Type 1 Diabetes, Pediatric Diabetes, Continuous Glucose Monitoring, Digital Therapeutic, Serious Game, Artificial Intelligence, Diabetes Distress, Fear of Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shifa International HospitalUniversity, hospital or other
- Collaborators
- Al Ain University
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 24 Jul 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.
Type 1 diabetes diagnosed in childhood requires rapid acquisition of complex self-management skills while children and caregivers are also adapting emotionally and socially to a chronic condition. Standard diabetes education is often delivered early after diagnosis, is information intensive, and is not usually personalized to real-time glucose patterns, emotional state, child developmental stage, or family communication needs.
This study will evaluate GlycoQuest, an AI-adaptive, continuous glucose monitoring-integrated serious game digital therapeutic for children and adolescents newly diagnosed with type 1 diabetes and their primary caregivers. GlycoQuest uses CGM-linked gameplay, a glucose-responsive digital avatar, AI-personalized learning pathways, parent-child collaborative modules, adaptive hypoglycemia and insulin decision simulations, and psychosocial adaptation content addressing diabetes distress, fear of hypoglycemia, stigma, illness acceptance, and autonomy transition.
This randomized controlled trial will enroll 110 parent-child dyads. Children aged 6 to 17 years with type 1 diabetes diagnosed within the previous 3 months will be randomized 1:1 to GlycoQuest plus standard care or enhanced digital psychoeducation plus standard care. The intervention period will be 6 months, with follow-up to 8 months. The co-primary outcomes are change in CGM-derived time in range, defined as 70 to 180 mg/dL, and child diabetes distress at 8 months. Secondary outcomes include time below range, glycemic variability, HbA1c, severe hypoglycemia, diabetic ketoacidosis readmissions, insulin omission, quality of life, fear of hypoglycemia, parental stress, diabetes family conflict, self-efficacy, engagement, and implementation outcomes.
Detailed description
GlycoQuest is a precision behavioral digital therapeutic designed for children and adolescents newly diagnosed with type 1 diabetes and their caregivers. The intervention integrates continuous glucose monitoring data, AI-driven personalization, serious game mechanics, behavioral science, and family-centered psychosocial support. The study is designed to test whether a CGM-linked adaptive game can improve glycemic outcomes and psychosocial adaptation during the critical first year after diagnosis.
The game is structured as a narrative role-playing environment in which the child's avatar responds to real-world glucose patterns. CGM-derived glucose trends influence in-game state, quest allocation, feedback, and reinforcement. The platform includes modules on CGM interpretation, insulin safety, carbohydrate estimation, hypoglycemia recognition and treatment, sick-day decision-making, school and peer interactions, stigma, illness acceptance, and gradual transfer of diabetes responsibility. Parent-child collaborative gameplay modules address communication, shared problem solving, caregiver fear of hypoglycemia, child autonomy, and diabetes-related family conflict.
The AI personalization engine adapts game content using multiple signal streams, including CGM patterns, engagement behavior, in-game decision errors, literacy and comprehension markers, and brief emotional check-ins. The system classifies recurring self-management challenges and delivers personalized gameplay, simulations, repetition, caregiver prompts, and psychosocial support. The platform does not provide autonomous insulin dosing advice and does not replace clinical care. Safety-critical content is governed by clinician-approved rules, and families remain under the care of their usual pediatric diabetes team.
Participants will be randomized to GlycoQuest plus standard care or enhanced digital psychoeducation plus standard care. The comparator is a professionally designed digital education app containing diabetes education materials matched for content coverage but without AI personalization, CGM-linked gameplay, adaptive algorithms, serious game mechanics, or parent-child co-play. The primary follow-up time point is 6 months, with extended follow-up at 8 months to assess durability, safety, engagement, and implementation outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized individually in a 1:1 ratio to either GlycoQuest plus standard diabetes care or enhanced digital psychoeducation plus standard diabetes care. Both groups will be followed for 8 months, with the primary endpoint assessed at 6 months.
| Arm | Type | Receives |
|---|---|---|
| Behavioral: GlycoQuest Digital Therapeutic | Experimental | Behavioral: GlycoQuest Digital TherapeuticParticipants randomized to this arm will receive GlycoQuest in addition to standard pediatric diabetes care. GlycoQuest is an AI-adaptive, CGM-integrated serious game digital therapeutic for children and adolescents newly diagnosed with type 1 diabetes and their caregivers. The platform uses CGM-linked gameplay, a glucose-responsive digital avatar, AI-personalized learning pathways, parent-child collaborative modules, adaptive hypoglycemia and insulin decision simulations, and psychosocial adaptation content. The intervention is delivered over 6 months, with follow-up to 8 months. |
| Enhanced Digital Psychoeducation | Active comparator | Behavioral: Enhanced Digital PsychoeducationParticipants randomized to this arm will receive enhanced digital psychoeducation in addition to standard pediatric diabetes care. The comparator consists of a professionally designed digital library of diabetes education materials, including text, illustrations, videos, glossary functions, and links to validated diabetes resources. It is matched to GlycoQuest for general content coverage but does not include serious game mechanics, AI personalization, CGM-linked gameplay, adaptive algorithms, or parent-child co-play features. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Child or adolescent aged 6 to 17 years at enrollment.
- Diagnosis of type 1 diabetes confirmed by a pediatric endocrinologist according to standard clinical criteria.
- Type 1 diabetes diagnosed within the previous 3 months.
- Primary caregiver aged 18 years or older willing to participate as part of a parent-child dyad.
- Current use of continuous glucose monitoring or willingness to initiate CGM as part of standard diabetes care.
Key exclusion criteria (6 listed)
- Type 1 diabetes diagnosed more than 3 months before enrollment.
- Concurrent participation in another intensive diabetes behavioral intervention trial.
- Significant developmental, intellectual, visual, motor, or psychiatric condition that, in the opinion of the clinical team, would preclude meaningful engagement with the digital game interface or study procedures.
- Acute psychiatric instability or safety concern requiring urgent specialist intervention.
- Planned transfer to a different diabetes care provider within 6 months.
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 |
|---|---|---|
| GlycoQuest Digital TherapeuticGlycoQuest is an AI-adaptive, CGM-integrated serious game digital therapeutic designed for children and adolescents newly diagnosed with type 1 diabetes and their caregivers. The intervention includes real-time CGM-linked gameplay, a glucose-responsive digital avatar, AI-personalized content allocation, adaptive insulin and hypoglycemia decision simulations, parent-child collaborative missions, spaced repetition, reward-based learning, self-efficacy reinforcement, and psychosocial adaptation modules addressing diabetes distress, fear of hypoglycemia, stigma, illness acceptance, and autonomy transition. GlycoQuest does not provide autonomous insulin dosing recommendations and does not replace clinical care. | Behavioural | Behavioral: GlycoQuest Digital Therapeutic |
| Enhanced Digital PsychoeducationEnhanced Digital Psychoeducation is a study-branded digital education app providing structured diabetes education content for children, adolescents, and caregivers. It includes educational modules, illustrations, videos, glossary functions, and links to validated diabetes resources. The comparator does not include AI personalization, CGM-linked gameplay, serious game mechanics, adaptive algorithms, digital twin functions, or parent-child co-play modules. | Behavioural | Enhanced Digital Psychoeducation |
Primary outcome
Change in CGM-Derived Time in Range at 8 Months
Time frame: Baseline to 8 months
Change from baseline to 8 months in the percentage of time spent in the glucose target range of 70 to 180 mg/dL, measured using continuous glucose monitoring data.
8 secondary outcomes
Change in Pediatric Diabetes Distress at 8 Months
Time frame: Baseline to 8 months
Change in CGM-Derived Time Below 70 mg/dL
Time frame: Baseline to 8 months
Change in CGM-Derived Time Above 180 mg/dL
Time frame: Baseline to 8 months
Change in CGM-Derived Glucose Coefficient of Variation
Time frame: Baseline to 8 months
Change in HbA1c
Time frame: Baseline, 6 and 8 months
Number of Severe Hypoglycemia Events
Time frame: Baseline to 8 months
Change in CGM-Derived Time Below 54 mg/dL
Time frame: Baseline to 8 months
Change in CGM-Derived Time Above 250 mg/dL
Time frame: Baseline to 8 months
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 24 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published primary results will be made available after publication, subject to ethics approval, institutional data-sharing agreements, and protection of participant privacy. Shared data may include de-identified clinical outcomes, CGM-derived outcome metrics, questionnaire scores, and intervention engagement variables. Data that could reasonably identify child participants or families, including raw high-resolution CGM streams linked to timestamps or free-text responses, will not be shared without additional safeguards.
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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.
Saima Abbass, MD, PhD study director
Shifal hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlycoQuest Digital Therapeutic and Enhanced Digital Psychoeducation in people with Type 1 Diabetes Mellitus (T1DM) and Diabetes Distress, run by Shifa International Hospital 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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 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?
Contact Nadia Hussain, MD, PhD (0505440153, nadia.hussain@aau.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CGM-Derived Time in Range at 8 Months (time frame: Baseline to 8 months). 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 24 Jul 2026.