Diabetes Distress, Family Conflict, Hypoglycemia (Diabetic), Type 1 Diabetes Mellitus (T1DM)
Conditions
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
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.
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.
Interventions
BEHAVIORALGlycoQuest Digital Therapeutic
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.
BEHAVIORALEnhanced Digital Psychoeducation
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.
Sponsors
Shifa International Hospital
Al Ain University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants, caregivers, and intervention support staff cannot be blinded because of the nature of the digital behavioral intervention. Laboratory personnel assessing HbA1c, outcome assessors abstracting clinical events, and statisticians conducting primary analyses will be masked to group allocation where feasible.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CGM-Derived Time in Range at 8 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Diabetes Distress at 8 Months | Baseline to 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. |
| Change in CGM-Derived Time Below 70 mg/dL | Baseline to 8 months | Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose below 70 mg/dL. |
| Change in CGM-Derived Time Above 180 mg/dL | Baseline to 8 months | Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose above 180 mg/dL. |
| Change in CGM-Derived Glucose Coefficient of Variation | Baseline to 8 months | 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. |
| Change in HbA1c | Baseline, 6 and 8 months | Change from baseline in glycated hemoglobin A1c (HbA1c), measured in percentage points, at 6 months and 8 months. |
| Number of Severe Hypoglycemia Events | Baseline to 8 months | 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. |
| Change in CGM-Derived Time Below 54 mg/dL | Baseline to 8 months | Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose below 54 mg/dL. |
| Change in CGM-Derived Time Above 250 mg/dL | Baseline to 8 months | Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose above 250 mg/dL. |
Countries
Pakistan
Contacts
CONTACTNadia Hussain, MD, PhD
STUDY_DIRECTORSaima Abbass, MD, PhD
Shifal hospital
Outcome results
None listed