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

NCT07726680 | Recruiting

• 3 other identifiers: SH-34988971SIAC-02907GlycoQuest
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus (T1DM); Diabetes Distress; Hypoglycemia (Diabetic); Family Conflict

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

Outcome Measures

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.

  Baseline to 8 months

Secondary Outcomes (8)

• 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

Other Outcomes (16)

• Number of Diabetic Ketoacidosis Hospital Readmissions

  Baseline to 8 months

• Insulin Omission Frequency

  Baseline to 8 months

• Change in Fear of Hypoglycemia

  Baseline to 8 months

Study Arms (2)

Behavioral: GlycoQuest Digital Therapeutic

EXPERIMENTAL

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

Enhanced Digital Psychoeducation

ACTIVE COMPARATOR

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

Interventions

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.

Behavioral: GlycoQuest Digital Therapeutic

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.

Enhanced Digital Psychoeducation

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shifa International Hospital: lead
• Al Ain University: collaborator

Study Sites (1)

Shifa International hospital

Lahore, Punjab Province, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Saima Abbass, MD, PhD

  Shifal hospital

  STUDY DIRECTOR

Central Study Contacts

Nadia Hussain, MD, PhD

CONTACT

0505440153; nadia.hussain@aau.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: July 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication of the primary trial results and ending 5 years after publication.
• 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.

Locations

PA (1)