NCT07726680 GlycoQuest: An AI-Adaptive CGM-Integrated Serious Game for Pediatric Type 1 Diabetes

Eligibility & Interventions

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This trial targets 110 participants in total. It began in 2026-06-01 with a primary completion date of 2026-11-01.

Brief 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.

Eligibility Criteria

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.

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