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

21. juli 2026 opdateret af: Saima Abass Tahammal, Shifa International Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

110

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Rekruttering
        • Shifa International hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Aktiv komparator: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in CGM-Derived Time in Range at 8 Months
Tidsramme: 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.
Baseline to 8 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pediatric Diabetes Distress at 8 Months
Tidsramme: 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.
Baseline to 8 months
Change in CGM-Derived Time Below 70 mg/dL
Tidsramme: Baseline to 8 months
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
Tidsramme: Baseline to 8 months
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
Tidsramme: 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.
Baseline to 8 months
Change in HbA1c
Tidsramme: Baseline, 6 and 8 months
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
Tidsramme: 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.
Baseline to 8 months
Change in CGM-Derived Time Below 54 mg/dL
Tidsramme: Baseline to 8 months
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
Tidsramme: Baseline to 8 months
Change from baseline to 8 months in the percentage of continuous glucose monitoring time with glucose above 250 mg/dL.
Baseline to 8 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Diabetic Ketoacidosis Hospital Readmissions
Tidsramme: 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.
Baseline to 8 months
Insulin Omission Frequency
Tidsramme: 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.
Baseline to 8 months
Change in Fear of Hypoglycemia
Tidsramme: 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.
Baseline to 8 months
Change in Diabetes Family Conflict
Tidsramme: 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.
Baseline to 8 months
Change in Diabetes Self-Efficacy
Tidsramme: 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.
Baseline to 8 months
Change in Pediatric Diabetes-Specific Quality of Life
Tidsramme: 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.
baseline to 8 months
Change in Caregiver Diabetes Distress
Tidsramme: 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.
Baseline to 8 months
Number of Diabetes-Related School Days Missed
Tidsramme: 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.
Baseline to 8 months
Total Number of Unscheduled Diabetes-Related Healthcare Encounters
Tidsramme: 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.
Baseline to 8 months
Number of Digital Intervention Sessions Initiated
Tidsramme: 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.
From intervention initiation to 6 months
Digital Intervention Session Duration
Tidsramme: 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.
From intervention initiation to 6 months
Digital Intervention Module Completion
Tidsramme: 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.
From intervention initiation to 6 months
Parent-Child Co-Play Activity Completion
Tidsramme: 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.
From intervention initiation to 6 months
Digital Intervention Retention at 6 Months
Tidsramme: 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
Tidsramme: 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.
At 3 months and 6 months
Change in Parent-Reported Fear of Hypoglycemia
Tidsramme: 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.
Baseline to 8 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shifa International Hospital

Samarbejdspartnere

Al Ain University

Efterforskere

  • Studieleder: Saima Abbass, MD, PhD, Shifal hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2026

Primær færdiggørelse (Anslået)

1. november 2026

Studieafslutning (Anslået)

30. november 2026

Datoer for studieregistrering

Først indsendt

26. maj 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SH-34988971
  • SIAC-02907 (Andet bevillings-/finansieringsnummer: Shifa Hospital Research Council grant)
  • GlycoQuest (Anden identifikator: Shifa Hospital Research Council grant)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

Beginning 12 months after publication of the primary trial results and ending 5 years after publication.

IPD-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med GlycoQuest Digital Therapeutic

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in India

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner