NCT07726680Recruiting
GlycoQuest: An AI-Adaptive CGM-Integrated Serious Game for Pediatric Type 1 Diabetes
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
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 26 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- Shifa International Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT07726680
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 1 Jun 2026 to the primary completion date, 1 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Type 1 diabetes diagnosed more than 3 months before enrollment.
- Concurrent participation in another intensive diabetes behavioral intervention trial.
Other illness
- 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.
Other
- Absence of internet access that cannot be addressed by study support.
Who the study is looking for
- 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.
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shifa International hospital Coordinator of this site? Confirm its status | Lahore | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.