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

NCT07470905 | Completed

• 2 other identifiers: Regency-IEC-16084IEC 16084 / 160152 / 16015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

DiaBuddy; Clinical decision support; Sick day; Insulin dose; Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Change in Hemoglobin A1c

  Over three months

Secondary Outcomes (2)

• CGM metric

  3 months

• Quality of life score

  Three months

Study Arms (1)

DiaBuddy™ mobile decision-support application.

EXPERIMENTAL

Participants recieved DiaBuddy™ mobile decision-support application.

Device: Access to DiaBuddy tool

Interventions

Access to DiaBuddy tool DEVICE

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

DiaBuddy™ mobile decision-support application.

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed Type 1 Diabetes Mellitus for more than 1 year Age 5 to 18 years Attending pediatric endocrinology outpatient clinic at Regency Center for Diabetes Endocrinology and Research, Kanpur Caregiver willing and able to use a smartphone application Written informed consent from parent or guardian and assent from participant where applicable

You may not qualify if:

• Type 2 diabetes or other forms of diabetes Significant comorbidity is known to independently affect glycemic control No smartphone access in the household Prior use of the DiaBuddy application Incomplete follow-up data at 3 months

Sponsors & Collaborators

• Regency Hospital Kanpur: lead

Study Sites (1)

Regency Hospital

Kanpur, Uttar Pradesh, 208001, India

Location

Related Publications (1)

• Mahapatra A, Paimode S, Banerjee S, Shukla P, Sachan N, Yadav V, Bajpai A. Development and Preclinical Validation of DiaBuddy, a Point-of-Care Decision Support Tool for Children with Type 1 Diabetes: A Pilot Clinical Study. Horm Res Paediatr. Under review. Preprint: medRxiv 2026; MEDRXIV/2026/347874.

  RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: DiaBuddy™ mobile decision-support application. Participants received structured training at enrollment followed by unrestricted home access for 3 months.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 13, 2026
• Study Start: July 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)