Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Sultan Qaboos University
- Enrollment
- 440
- Primary Endpoint
- Change in HbA1c from Baseline to 6 Months
Overview
Brief Summary
This is a multi-centre, prospective, randomized, open-label controlled trial designed to evaluate the effectiveness of a flexible digital insulin dose calculator in children under 12 years of age with Type 1 Diabetes Mellitus (T1DM) managed with multiple daily injections (MDI). Participants will be stratified by continuous glucose monitoring (CGM) use and baseline HbA1c, and randomised to receive either standard care alone or standard care plus the insulin dose calculator tool for 6 months.
The primary outcome is the change in HbA1c from baseline to 6 months. Secondary outcomes include CGM-derived glycaemic metrics (Time in Range, Time Below Range, Time Above Range, and Coefficient of Variation), total daily insulin dose (units/kg/day), healthcare provider contact frequency, and caregiver-reported usability and satisfaction. The study aims to determine whether the use of a structured digital decision-support tool improves glycaemic control and supports safer insulin dosing in paediatric patients with T1DM.
Detailed Description
Type 1 Diabetes Mellitus (T1DM) in children requires intensive insulin therapy and frequent dose adjustments based on carbohydrate intake, glucose levels, and individualised insulin parameters. Although carbohydrate counting is widely practised in paediatric diabetes management, translating these principles into accurate insulin dosing remains complex. Caregivers must integrate insulin-to-carbohydrate ratios, correction factors, pre-meal glucose values, and -when applicable- continuous glucose monitoring (CGM) trend information. This process is prone to calculation errors and variability, which may contribute to suboptimal glycaemic outcomes.
While advanced technologies such as insulin pumps and hybrid closed-loop systems can automate insulin delivery, many children worldwide continue to use multiple daily injections (MDI). For this population, structured digital decision-support tools may help standardise insulin dose calculations and reduce caregiver burden. However, high-quality prospective evidence evaluating such tools in paediatric MDI users remains limited.
This study is a multi-centre, prospective, randomised, open-label controlled trial evaluating the clinical impact of a flexible digital insulin dose calculator in children under 12 years of age with established T1DM managed with MDI and carbohydrate counting. Participants will be stratified according to CGM use and baseline glycaemic control, then randomised to either standard care alone or standard care plus access to the insulin dose calculator for a 6-month period.
The intervention consists of structured training in the use of the digital calculator, which integrates individualised insulin-to-carbohydrate ratios, correction factors, and glucose inputs to generate dosing recommendations. The study will assess whether integration of this tool into routine care improves overall glycaemic control and glycaemic stability compared with standard practice alone. In addition, the study will explore effects on insulin titration patterns, healthcare utilisation, and caregiver experience.
The trial is designed to reflect real-world paediatric diabetes practice across multiple international sites. Data will be collected during routine clinical encounters over a 6-month follow-up period. The findings are expected to provide evidence regarding the effectiveness, feasibility, and scalability of a non-invasive digital decision-support intervention aimed at improving insulin dosing accuracy and supporting families managing paediatric T1DM.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children and adolescents \< 12 years
- •Diagnosed with Type 1 Diabetes Mellitus (T1DM)
- •Duration of diagnosis \> 1 year
- •Using a multiple daily injection (MDI) regimen
- •Practising carbohydrate counting for at least 1 month before enrolment
Exclusion Criteria
- •Use of an existing insulin dose calculator (e.g., mobile application or bolus advisor) within the last 3 months
- •Diagnosis of other types of diabetes (e.g., Type 2 diabetes mellitus, monogenic diabetes)
- •Use of insulin regimens other than multiple daily injections (MDI) (e.g., insulin pump therapy)
Arms & Interventions
Standard Care Alone
Participants receive routine standard diabetes care according to local clinical practice, including insulin dose adjustments based on carbohydrate counting principles, without access to the digital insulin dose calculator. Participants are followed for 6 months during routine clinic visits.
Flexible Insulin Dose Calculator + Standard Care
Participants receive standard diabetes care plus access to a flexible digital insulin dose calculator designed to support carbohydrate-based insulin dosing. Caregivers receive structured training on tool use at baseline. The tool integrates individualized insulin-to-carbohydrate ratios, correction factors, and glucose inputs to generate dosing recommendations. Participants are followed for 6 months during routine clinic visits.
Intervention: Flexible Digital Insulin Dose Calculator (Behavioral)
Outcomes
Primary Outcomes
Change in HbA1c from Baseline to 6 Months
Time Frame: Baseline to 6 Months
The primary outcome is the difference in glycated haemoglobin (HbA1c) levels between baseline and 6 months. HbA1c will be measured as part of routine clinical care and analysed to compare changes between the intervention (digital insulin dose calculator plus standard care) and control (standard care alone) groups.
Secondary Outcomes
- Healthcare provider contact frequency during study follow-up(Baseline to 6 Months (assessed at 3 and 6 Months))
- Change in Total Daily Insulin Dose (units/kg/day)(Baseline, 3 Months, and 6 Months)
- Change in Time in Range (TIR)(Baseline, 3 Months, and 6 Months)
- Change in Time Below Range (TBR)(Baseline, 3 Months, and 6 Months)
- Change in Time Above Range (TAR)(Baseline, 3 Months, and 6 Months)
- Change in Glucose Coefficient of Variation (CV)(Baseline, 3 Months, and 6 Months)
- Caregiver diabetes distress(Baseline and 6 Months)
- Caregiver usability and satisfaction with the insulin dose calculator(3 Months and 6 Months)
Investigators
Dr. Hussain Al Saffar
Principal Investigator
Sultan Qaboos University