RecruitingNot Applicable

GlycoQuest: An AI-Adaptive CGM-Integrated Serious Game for Pediatric Type 1 Diabetes

Pakistan110 participantsStarted 2026-06-01

Plain-language 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. 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.

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in CGM-Derived Time in Range at 8 Months

Timeframe: Baseline to 8 months

Trial details

NCT IDNCT07726680

SponsorShifa International Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-01

Contact for this trial

Nadia Hussain, MD, PhD

0505440153 nadia.hussain@aau.ac.ae

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus (T1DM) trials