GlycoQuest: An AI-Adaptive CGM-Integrated Serious Game for Pediatric Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorShifa International Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GlycoQuest Digital Therapeutic
BehavioralGlycoQuest 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 Psychoeducation
BehavioralEnhanced 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Behavioral: GlycoQuest Digital TherapeuticExperimental treatment 1 intervention
Group B: Enhanced Digital PsychoeducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 8 monthsSecondary outcomes
1
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.
Time frame
Baseline to 8 months2
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.
Time frame
Baseline to 8 months3
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.
Time frame
Baseline to 8 months4
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.
Time frame
Baseline to 8 monthsOther outcomes
1
Number of Diabetic Ketoacidosis Hospital Readmissions
Cumulative number of hospital readmissions for diabetic ketoacidosis during the 8-month study period, confirmed by medical record review. Higher values indicate a greater number of diabetic ketoacidosis readmissions.
Time frame
Baseline to 8 months2
Insulin Omission Frequency
Change from baseline to 8 months in insulin omission frequency, measured as the percentage of prescribed insulin doses omitted during the preceding 7 days, based on a participant- or caregiver-completed insulin-administration diary. The percentage is calculated as the number of prescribed doses not administered divided by the total number of prescribed doses, multiplied by 100. Values range from 0% to 100%, with higher percentages indicating more frequent insulin omission.
Time frame
Baseline to 8 months3
Change in Fear of Hypoglycemia
Change from baseline to 8 months in child-reported fear of hypoglycemia, measured using the study-developed GlycoQuest Child Hypoglycemia Fear Questionnaire. Total scores range from 0 to 40, with higher scores indicating greater fear of hypoglycemia.
Time frame
Baseline to 8 months4
Change in Diabetes Family Conflict
Change from baseline to 8 months in diabetes-related family conflict, measured using the study-developed GlycoQuest Diabetes Family Conflict Questionnaire. Total scores range from 0 to 40, with higher scores indicating greater diabetes-related family conflict.
Time frame
Baseline to 8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shifa International Hospital
Lead sponsor
Al Ain University
Collaborator
Source ClinicalTrials.gov