Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:10 AM
Study NCT ID:
NCT07427134
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pediatric Insulin Plan Calculator for T1DM Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-21', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c from Baseline to 6 Months', 'timeFrame': 'Baseline to 6 Months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Time in Range (TIR)', 'timeFrame': 'Baseline, 3 Months, and 6 Months', 'description': '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.'}, {'measure': 'Change in Time Below Range (TBR)', 'timeFrame': 'Baseline, 3 Months, and 6 Months', 'description': 'For participants using CGM, change in the percentage of time glucose is \\<70 mg/dL (\\<4 mmol/L) based on CGM reports.'}, {'measure': 'Change in Time Above Range (TAR)', 'timeFrame': 'Baseline, 3 Months, and 6 Months', 'description': 'For participants using CGM, change in the percentage of time glucose is \\>180 mg/dL (\\>10 mmol/L) based on CGM reports.'}, {'measure': 'Change in Glucose Coefficient of Variation (CV)', 'timeFrame': 'Baseline, 3 Months, and 6 Months', 'description': 'For participants using CGM, change in glucose coefficient of variation (CV, %) derived from CGM reports as a measure of glycaemic variability.'}, {'measure': 'Change in Total Daily Insulin Dose (units/kg/day)', 'timeFrame': 'Baseline, 3 Months, and 6 Months', 'description': 'Change in total daily insulin dose normalized to body weight (units/kg/day), calculated from clinical records at each assessment time point'}, {'measure': 'Healthcare provider contact frequency during study follow-up', 'timeFrame': 'Baseline to 6 Months (assessed at 3 and 6 Months)', 'description': 'Number of diabetes-related healthcare provider contacts (e.g., clinic, telemedicine, phone consultations) recorded over the study period and/or between visits'}, {'measure': 'Caregiver diabetes distress', 'timeFrame': 'Baseline and 6 Months', 'description': '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.\''}, {'measure': 'Caregiver usability and satisfaction with the insulin dose calculator', 'timeFrame': '3 Months and 6 Months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 1 Diabetes Mellitus', 'Clinical Decision Support Tool', 'Digital Health Intervention', 'Insulin Dose Calculator'], 'conditions': ['Type 1 Diabetes Mellitus', 'Type 1 Diabetes Mellitus (T1DM)', 'T1DM', 'T1DM - Type 1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nWhile 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.\n\nThis 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents \\< 12 years\n* Diagnosed with Type 1 Diabetes Mellitus (T1DM)\n* Duration of diagnosis \\> 1 year\n* Using a multiple daily injection (MDI) regimen\n* Practising carbohydrate counting for at least 1 month before enrolment\n\nExclusion Criteria:\n\n* Use of an existing insulin dose calculator (e.g., mobile application or bolus advisor) within the last 3 months\n* Diagnosis of other types of diabetes (e.g., Type 2 diabetes mellitus, monogenic diabetes)\n* Use of insulin regimens other than multiple daily injections (MDI) (e.g., insulin pump therapy)'}, 'identificationModule': {'nctId': 'NCT07427134', 'acronym': 'FLEXI-T1D', 'briefTitle': 'Pediatric Insulin Plan Calculator for T1DM Management', 'organization': {'class': 'OTHER', 'fullName': 'Sultan Qaboos University'}, 'officialTitle': 'Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management', 'orgStudyIdInfo': {'id': 'SultanQU-PEDU-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Flexible Insulin Dose Calculator + Standard Care', 'description': '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.', 'interventionNames': ['Behavioral: Flexible Digital Insulin Dose Calculator']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care Alone', 'description': '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.'}], 'interventions': [{'name': 'Flexible Digital Insulin Dose Calculator', 'type': 'BEHAVIORAL', 'otherNames': ['Insulin Dose Decision-Support Tool'], 'description': '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.', 'armGroupLabels': ['Flexible Insulin Dose Calculator + Standard Care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Hussain Alsaffar, FACE, MSc, FRCPCH, CCT, MBChB', 'role': 'CONTACT', 'email': 'hussaina@squ.edu.om', 'phone': '0096896399402'}, {'name': 'Nandu Kumar Thalange, Professor', 'role': 'CONTACT', 'email': 'n.thalange@genesis-dubai.com', 'phone': '00971589466920'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '6 months after publication of the primary study results. Up to 2 years after publication of the primary results.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': 'De-identified individual participant data underlying the published results (including primary and secondary outcome data, data dictionary, and statistical analysis plan) may be made available to qualified researchers for scientifically sound research purposes. Access will be granted upon reasonable request to the Principal Investigator and subject to institutional review, ethics approval where applicable, and execution of a formal data-sharing agreement. Data will be provided in a de-identified format and shared through secure electronic transfer or a controlled-access repository in accordance with applicable data protection regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sultan Qaboos University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Mosul', 'class': 'OTHER'}, {'name': "University of Child Health Sciences and Children's Hospital, Lahore", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Hussain Al Saffar', 'investigatorAffiliation': 'Sultan Qaboos University'}}}}