An interventional study of GlycoQuest Digital Therapeutic and Enhanced Digital Psychoeducation in Type 1 Diabetes Mellitus (T1DM), Diabetes Distress and Hypoglycemia (Diabetic), sponsored by Shifa International Hospital. Recruiting at 1 site in Pakistan. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Shifa International Hospital · Not applicable, Interventional, and Treatment
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 110 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Shifa International Hospital is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 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.
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.
Time frame: Baseline to 8 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 8 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 8 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Nov 2026, 5 months after the start.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 5 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
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Shifa International Hospital