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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Family Conflict; Diabetes Distress; Type 1 Diabetes Mellitus (T1DM); Hypoglycemia (Diabetic)
• Intervention / Treatment: Behavioral: GlycoQuest Digital Therapeutic; Behavioral: Enhanced Digital Psychoeducation

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia Hussain, MD, PhD; Phone Number: 0505440153; Email: nadia.hussain@aau.ac.ae

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan
      • Recruiting
      • Shifa International hospital
      • Contact: Saima Abbass, MD, PhD; Phone Number: 00923206503200; Email: saimaabasstahammal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral: GlycoQuest Digital Therapeutic; Participants randomized to this arm will receive GlycoQuest in addition to standard pediatric diabetes care. GlycoQuest is an AI-adaptive, CGM-integrated serious game digital therapeutic for children and adolescents newly diagnosed with type 1 diabetes and their caregivers. The platform 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. The intervention is delivered over 6 months, with follow-up to 8 months.	Behavioral: GlycoQuest 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.
Active Comparator: Enhanced Digital Psychoeducation; Participants randomized to this arm will receive enhanced digital psychoeducation in addition to standard pediatric diabetes care. The comparator consists of a professionally designed digital library of diabetes education materials, including text, illustrations, videos, glossary functions, and links to validated diabetes resources. It is matched to GlycoQuest for general content coverage but does not include serious game mechanics, AI personalization, CGM-linked gameplay, adaptive algorithms, or parent-child co-play features.	Behavioral: Enhanced 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 8 months
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.	Baseline to 8 months
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.	Baseline to 8 months
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.	Baseline to 8 months
Change in HbA1c	Change from baseline in glycated hemoglobin A1c (HbA1c), measured in percentage points, at 6 months and 8 months.	Baseline, 6 and 8 months
Number of Severe Hypoglycemia Events	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.	Baseline to 8 months
Change in CGM-Derived Time Below 54 mg/dL	Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose below 54 mg/dL.	Baseline to 8 months
Change in CGM-Derived Time Above 250 mg/dL	Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose above 250 mg/dL.	Baseline to 8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 8 months
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.	Baseline to 8 months
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.	Baseline to 8 months
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.	Baseline to 8 months
Change in Diabetes Self-Efficacy	Change from baseline to 8 months in child-reported diabetes self-efficacy, measured using the study-developed GlycoQuest Child Diabetes Self-Efficacy Questionnaire. Total scores range from 0 to 40, with higher scores indicating greater diabetes self-efficacy.	Baseline to 8 months
Change in Pediatric Diabetes-Specific Quality of Life	Change from baseline to 8 months in child-reported diabetes-specific quality of life, measured using the study-developed GlycoQuest Pediatric Diabetes Quality-of-Life Questionnaire. Total scores range from 0 to 40, with higher scores indicating better diabetes-specific quality of life.	baseline to 8 months
Change in Caregiver Diabetes Distress	Change from baseline to 8 months in caregiver-reported diabetes distress, measured using the study-developed GlycoQuest Caregiver Diabetes Distress Questionnaire. Total scores range from 0 to 40, with higher scores indicating greater caregiver diabetes distress.	Baseline to 8 months
Number of Diabetes-Related School Days Missed	Cumulative number of school days missed because of diabetes-related causes during the 8-month study period. Higher values indicate greater diabetes-related school absenteeism.	Baseline to 8 months
Total Number of Unscheduled Diabetes-Related Healthcare Encounters	Cumulative number of unscheduled diabetes-related healthcare encounters during the 8-month study period, including unscheduled diabetes clinic contacts, emergency department visits, hospital admissions, and other urgent diabetes-related healthcare encounters. Each distinct encounter will be counted once, with higher values indicating greater healthcare utilization.	Baseline to 8 months
Number of Digital Intervention Sessions Initiated	Cumulative number of GlycoQuest digital intervention sessions initiated by each participant during the 6-month intervention period, automatically recorded by the digital platform. Higher values indicate more frequent intervention use.	From intervention initiation to 6 months
Digital Intervention Session Duration	Total time, measured in minutes, that the participant spent using the GlycoQuest digital intervention during the 6-month intervention period, automatically recorded by the digital platform. Higher values indicate greater intervention use.	From intervention initiation to 6 months
Digital Intervention Module Completion	Percentage of assigned GlycoQuest intervention modules completed by the participant during the 6-month intervention period, automatically recorded by the digital platform. The percentage is calculated as the number of assigned modules completed divided by the total number of assigned modules, multiplied by 100. Values range from 0% to 100%, with higher percentages indicating greater module completion.	From intervention initiation to 6 months
Parent-Child Co-Play Activity Completion	Percentage of assigned GlycoQuest parent-child co-play activities completed during the 6-month intervention period, automatically recorded by the digital platform. The percentage is calculated as the number of assigned co-play activities completed divided by the total number of assigned co-play activities, multiplied by 100. Values range from 0% to 100%, with higher percentages indicating greater co-play activity completion.	From intervention initiation to 6 months
Digital Intervention Retention at 6 Months	Percentage of participants assigned to the GlycoQuest intervention who remain active users at 6 months. A participant is considered retained if they initiate at least one GlycoQuest session during the final 30 days of the 6-month intervention period. The percentage is calculated as the number of participants meeting the retention criterion divided by the total number of participants who initiated the intervention, multiplied by 100. Values range from 0% to 100%, with higher percentages indicating greater intervention retention.	At 6 months
Digital Intervention Usability	User-reported usability of the GlycoQuest digital intervention, measured using the study-developed GlycoQuest Digital Intervention Usability Questionnaire. Total scores range from 10 to 50, with higher scores indicating better perceived usability.	At 3 months and 6 months
Change in Parent-Reported Fear of Hypoglycemia	Change from baseline to 8 months in parent-reported fear of hypoglycemia, measured using the study-developed GlycoQuest Parent Hypoglycemia Fear Questionnaire. Total scores range from 0 to 40, with higher scores indicating greater fear of hypoglycemia.	Baseline to 8 months

Collaborators and Investigators

• Sponsor: Shifa International Hospital
• Collaborators: Al Ain University
• Investigators: Study Director: Saima Abbass, MD, PhD, Shifal hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; Artificial Intelligence; Type 1 Diabetes; Implementation Science; Self-Efficacy; Digital Therapeutic; Family-Centered Care; Diabetes Distress; Fear of Hypoglycemia; Time in Range; Behavioral Medicine; Serious Game; Pediatric Diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Hypoglycemia; Diabetes Mellitus, Type 1
• Other Study ID Numbers: SH-34988971; SIAC-02907 (Other Grant/Funding Number: Shifa Hospital Research Council grant); GlycoQuest (Other Identifier: Shifa Hospital Research Council grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the published primary results will be made available after publication, subject to ethics approval, institutional data-sharing agreements, and protection of participant privacy. Shared data may include de-identified clinical outcomes, CGM-derived outcome metrics, questionnaire scores, and intervention engagement variables. Data that could reasonably identify child participants or families, including raw high-resolution CGM streams linked to timestamps or free-text responses, will not be shared without additional safeguards.
• IPD Sharing Time Frame: Beginning 12 months after publication of the primary trial results and ending 5 years after publication.
• IPD Sharing Access Criteria: Data will be available to qualified researchers who submit a methodologically sound proposal and obtain approval from the study steering committee or designated institutional data access committee. Requestors will be required to sign a data use agreement and comply with applicable privacy, security, and child-protection requirements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No