Type 1 Diabetes MellitusFLEXI-T1DNCT07427134
Pediatric Insulin Plan Calculator for T1DM Management
A study testing Flexible Digital Insulin Dose Calculator in people with Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus (T1DM), run by Sultan Qaboos University at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus (T1DM), T1DM
- What is being tested?
- Flexible Digital Insulin Dose Calculator
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 3 May 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Iraq1 site, 1 recruiting
- Recruiting
University of Mosul
Mosul
Dr Farah Othman, MBBS, 009647703833560, fsy@uomosul.edu.iq
Pakistan1 site, 1 recruiting
- Recruiting
University Child Hospital
Lahore
Dr Sommayya Aftab, MBBS, +923314941549, sommayyaaftab@gmail.com
About this study
Official title: Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus (T1DM), T1DM, T1DM - Type 1 Diabetes Mellitus
- Being tested
- Flexible Digital Insulin Dose Calculator
- Keywords
- Type 1 Diabetes Mellitus, Clinical Decision Support Tool, Digital Health Intervention, Insulin Dose Calculator
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible Digital Insulin Dose CalculatorBehavioural
Also called Insulin Dose Decision-Support Tool
The flexible digital insulin dose calculator is a structured decision-support tool designed specifically for children with Type 1 Diabetes Mellitus managed with multiple daily injections and carbohydrate counting. Unlike basic insulin calculation applications that consider limited variables, this tool integrates individualised insulin-to-carbohydrate ratios, correction factors (insulin sensitivity), pre-meal glucose values, and glucose trends (when available) to generate dosing recommendations. The tool is non-automated and does not deliver insulin; it supports caregiver decision-making. It is intended for real-world clinical use and is implemented alongside routine diabetes care with standardised training at baseline. The intervention focuses on improving dosing accuracy and consistency rather than replacing clinician oversight or insulin therapy.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Insulin Dose Calculator + Standard Care | Experimental | 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. Receives: Behavioral: Flexible Digital Insulin Dose Calculator |
| Standard Care Alone | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from 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.
Measured: Baseline to 6 Months
Secondary outcomes (8)
Change in Time in Range (TIR)
For participants using CGM, change in the percentage of time glucose is within 70-180 mg/dL (4-10 mmol/L) based on CGM reports.
Measured: Baseline, 3 Months, and 6 Months
Change in Time Below Range (TBR)
For participants using CGM, change in the percentage of time glucose is <70 mg/dL (<4 mmol/L) based on CGM reports.
Measured: Baseline, 3 Months, and 6 Months
Change in Time Above Range (TAR)
For participants using CGM, change in the percentage of time glucose is >180 mg/dL (>10 mmol/L) based on CGM reports.
Measured: Baseline, 3 Months, and 6 Months
Change in Glucose Coefficient of Variation (CV)
For participants using CGM, change in glucose coefficient of variation (CV, %) derived from CGM reports as a measure of glycaemic variability.
Measured: Baseline, 3 Months, and 6 Months
Change in Total Daily Insulin Dose (units/kg/day)
Change in total daily insulin dose normalized to body weight (units/kg/day), calculated from clinical records at each assessment time point
Measured: Baseline, 3 Months, and 6 Months
Healthcare provider contact frequency during study follow-up
Number of diabetes-related healthcare provider contacts (e.g., clinic, telemedicine, phone consultations) recorded over the study period and/or between visits
Measured: Baseline to 6 Months (assessed at 3 and 6 Months)
Caregiver diabetes distress
Caregiver burden assessed using validated Diabetes Distress Scale instruments, comparing scores over follow-up. PARENT DIABETES DISTRESS SCALE (PARENT-DDS) questionnaire will be used. A mean item score or 0 - 1.9 should be considered "little or no distress," a mean item score between 2.0 - 2.9 should be considered 'moderate distress,' and a mean item score > 3.0 should be considered 'high distress.'
Measured: Baseline and 6 Months
Caregiver usability and satisfaction with the insulin dose calculator
Structured caregiver questionnaire assessing usability, satisfaction, and perceived value of the digital tool (intervention arm only). System Usability Scale (SUS) questionnaire will be used, which produces a score from 0 to 100 (not a percentage). The higher score indicates better usability. Below 50 means poor usability and >75 = Acceptable for clinical deployment.
Measured: 3 Months and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start3 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-group, randomised, open-label controlled trial. Participants are stratified by CGM use and baseline HbA1c, then randomised 1:1 to standard care alone or standard care plus a flexible digital insulin dose calculator, with follow-up at baseline, 3 months, and 6 months
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mosul, University of Child Health Sciences and Children's Hospital, Lahore
- Responsible party
- Principal investigator, Dr. Hussain Al Saffar, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427134
- Sponsor's protocol ID
- SultanQU-PEDU-001
- Acronym
- FLEXI-T1D
- Status last verified
- Jun 2026
- First submitted
- 15 Feb 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results may be made available upon reasonable request to the principal investigator, subject to institutional approval, data protection regulations, and a data-sharing agreement. Data sharing will not include direct identifiers and will comply with applicable ethical and legal requirements.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management
- ClinicalTrials.gov ID
- NCT07427134
- Acronym / sponsor ID
- FLEXI-T1D / SultanQU-PEDU-001
- Conditions
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus (T1DM), T1DM, T1DM - Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus, Clinical Decision Support Tool, Digital Health Intervention, Insulin Dose Calculator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Collaborators
- University of Mosul, University of Child Health Sciences and Children's Hospital, Lahore
- Study start
- 3 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-group, randomised, open-label controlled trial. Participants are stratified by CGM use and baseline HbA1c, then randomised 1:1 to standard care alone or standard care plus a flexible digital insulin dose calculator, with follow-up at baseline, 3 months, and 6 months
| Arm | Type | Receives |
|---|---|---|
| Flexible Insulin Dose Calculator + Standard Care | Experimental | Behavioral: Flexible Digital Insulin Dose CalculatorParticipants 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. |
| Standard Care Alone | No intervention | –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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexible Digital Insulin Dose CalculatorAlso: Insulin Dose Decision-Support ToolThe flexible digital insulin dose calculator is a structured decision-support tool designed specifically for children with Type 1 Diabetes Mellitus managed with multiple daily injections and carbohydrate counting. Unlike basic insulin calculation applications that consider limited variables, this tool integrates individualised insulin-to-carbohydrate ratios, correction factors (insulin sensitivity), pre-meal glucose values, and glucose trends (when available) to generate dosing recommendations. The tool is non-automated and does not deliver insulin; it supports caregiver decision-making. It is intended for real-world clinical use and is implemented alongside routine diabetes care with standardised training at baseline. The intervention focuses on improving dosing accuracy and consistency rather than replacing clinician oversight or insulin therapy. | Behavioural | Flexible Insulin Dose Calculator + Standard Care |
Primary outcome
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.
8 secondary outcomes
Change in Time in Range (TIR)
Time frame: Baseline, 3 Months, and 6 Months
Change in Time Below Range (TBR)
Time frame: Baseline, 3 Months, and 6 Months
Change in Time Above Range (TAR)
Time frame: Baseline, 3 Months, and 6 Months
Change in Glucose Coefficient of Variation (CV)
Time frame: Baseline, 3 Months, and 6 Months
Change in Total Daily Insulin Dose (units/kg/day)
Time frame: Baseline, 3 Months, and 6 Months
Healthcare provider contact frequency during study follow-up
Time frame: Baseline to 6 Months (assessed at 3 and 6 Months)
Caregiver diabetes distress
Time frame: Baseline and 6 Months
Caregiver usability and satisfaction with the insulin dose calculator
Time frame: 3 Months and 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results may be made available upon reasonable request to the principal investigator, subject to institutional approval, data protection regulations, and a data-sharing agreement. Data sharing will not include direct identifiers and will comply with applicable ethical and legal requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flexible Digital Insulin Dose Calculator in people with Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus (T1DM), run by Sultan Qaboos University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hussain Alsaffar, FACE, MSc, FRCPCH, CCT, MBChB (0096896399402, hussaina@squ.edu.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c from Baseline to 6 Months (time frame: Baseline to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.