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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in CGM-Derived Time in Range at 8 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in CGM-Derived Time in Range at 8 Months
时间窗: 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.
次要结局
- Change in Pediatric Diabetes Distress at 8 Months(Baseline to 8 months)
- Change in CGM-Derived Time Below 70 mg/dL(Baseline to 8 months)
- Change in CGM-Derived Time Above 180 mg/dL(Baseline to 8 months)
- Change in CGM-Derived Glucose Coefficient of Variation(Baseline to 8 months)
- Change in HbA1c(Baseline, 6 and 8 months)
- Number of Severe Hypoglycemia Events(Baseline to 8 months)
- Change in CGM-Derived Time Below 54 mg/dL(Baseline to 8 months)
- Change in CGM-Derived Time Above 250 mg/dL(Baseline to 8 months)
研究者
Saima Abass Tahammal
Medical director
Shifa International Hospital