Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07726680

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Type 1 Diabetes Mellitus (T1DM) Autoimmune Diseases Diabetes Distress Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Family Conflict Glucose Metabolism Disorders Hypoglycemia Hypoglycemia (Diabetic) Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shifa International hospital

Lahore, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Saima Abbass, MD, PhD

CONTACT

[email protected]

00923206503200

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GlycoQuest Digital Therapeutic

Behavioral

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.

Enhanced Digital Psychoeducation

Behavioral

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.

Primary outcomes

  1. Change in CGM-Derived Time in Range at 8 Months

    Time frame: 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 outcomes

  1. Change in Pediatric Diabetes Distress at 8 Months

    Time frame: 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.

  2. Change in CGM-Derived Time Below 70 mg/dL

    Time frame: Baseline to 8 months

    Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose below 70 mg/dL.

  3. Change in CGM-Derived Time Above 180 mg/dL

    Time frame: Baseline to 8 months

    Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose above 180 mg/dL.

  4. Change in CGM-Derived Glucose Coefficient of Variation

    Time frame: 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.

  5. Change in HbA1c

    Time frame: Baseline, 6 and 8 months

    Change from baseline in glycated hemoglobin A1c (HbA1c), measured in percentage points, at 6 months and 8 months.

  6. Number of Severe Hypoglycemia Events

    Time frame: 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.

  7. Change in CGM-Derived Time Below 54 mg/dL

    Time frame: Baseline to 8 months

    Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose below 54 mg/dL.

  8. Change in CGM-Derived Time Above 250 mg/dL

    Time frame: Baseline to 8 months

    Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose above 250 mg/dL.

Other outcomes

  1. Number of Diabetic Ketoacidosis Hospital Readmissions

    Time frame: Baseline to 8 months

    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.

  2. Insulin Omission Frequency

    Time frame: Baseline to 8 months

    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.

  3. Change in Fear of Hypoglycemia

    Time frame: Baseline to 8 months

    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.

  4. Change in Diabetes Family Conflict

    Time frame: Baseline to 8 months

    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.

  5. Change in Diabetes Self-Efficacy

    Time frame: Baseline to 8 months

    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.

  6. Change in Pediatric Diabetes-Specific Quality of Life

    Time frame: baseline to 8 months

    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.

  7. Change in Caregiver Diabetes Distress

    Time frame: Baseline to 8 months

    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.

  8. Number of Diabetes-Related School Days Missed

    Time frame: Baseline to 8 months

    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.

  9. Total Number of Unscheduled Diabetes-Related Healthcare Encounters

    Time frame: Baseline to 8 months

    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.

  10. Number of Digital Intervention Sessions Initiated

    Time frame: From intervention initiation to 6 months

    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.

  11. Digital Intervention Session Duration

    Time frame: From intervention initiation to 6 months

    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.

  12. Digital Intervention Module Completion

    Time frame: From intervention initiation to 6 months

    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.

  13. Parent-Child Co-Play Activity Completion

    Time frame: From intervention initiation to 6 months

    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.

  14. Digital Intervention Retention at 6 Months

    Time frame: 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.

  15. Digital Intervention Usability

    Time frame: At 3 months and 6 months

    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.

  16. Change in Parent-Reported Fear of Hypoglycemia

    Time frame: Baseline to 8 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nadia Hussain, MD, PhD

CONTACT

[email protected]

0505440153

Sponsors and collaborators

Lead sponsor

Shifa International Hospital

Other

Collaborators

  • Al Ain University

Registry information

Official study title

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

Acronym: GlycoQuest

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.