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Development and Preclinical Validation of DiaBuddy, a Point-of-Care Decision Support Tool for Children With Type 1 Diabetes: A Pilot Clinical Study

NCT07470905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-03-13

No results posted yet for this study

Summary

Type 1 Diabetes Mellitus (T1DM) in children requires precise insulin dose adjustments and reliable sick-day decision-making on a daily basis. In real-world practice, families frequently make errors in both domains, predisposing children to hypoglycemia, suboptimal glycemic control, and diabetic ketoacidosis (DKA). Access to structured diabetes education and specialist support is limited in India, creating an unmet need for accessible point-of-care decision support.

DiaBuddy™ is a comprehensive mobile decision-support application for pediatric T1DM developed at Regency Center for Diabetes, Endocrinology and Research, Kanpur. It integrates seven modules aligned with ISPAD 2022 clinical practice guidelines: Insulin Wizard (basal titration, bolus dosing, and correction doses), Sick-Day Guide (stepwise intercurrent illness management), Sugar Tracker (glucose logging with alerts), EatRite (meal planning with carbohydrate quantification using an India-specific food database of 10,245 foods), PlayRite (physical activity guidance), SleepRite (sleep hygiene monitoring), and Knowledge Base (patient and family education).

This study evaluated DiaBuddy™ in two sequential phases. Phase 1 was a preclinical vignette-based validation in which 37 families of children with T1DM independently completed 40 standardized clinical scenarios - 20 insulin-dosing and 20 sick-day - with responses compared against a blinded independent pediatric endocrinologist gold standard. Phase 2 was a prospective single-arm pilot clinical study in which 25 children aged 5 to 18 years with T1DM received structured DiaBuddy™ training and unrestricted home access for three months, with hemoglobin A1c, continuous glucose monitoring metrics, and health-related quality of life assessed at baseline and at three months.

The study aimed to establish whether DiaBuddy™ produces guideline-aligned insulin dosing and sick-day recommendations, whether it outperforms unaided family decision-making, and whether its use over three months is associated with improvements in glycemic control and quality of life in children with T1DM

Conditions

  • Type 1 Diabetes (T1D)

Interventions

DEVICE

Access to DiaBuddy tool

Children recieved access to DiaBuddy for insulin guidance and sick day management

Sponsors & Collaborators

  • Regency Hospital Kanpur

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470905 on ClinicalTrials.gov