[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625784":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":37,"responsibleParty":70,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":18,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Sultan Qaboos University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Flexible Digital Insulin Dose Calculator",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Flexible Digital Insulin Dose Calculator","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.",[9],[26],"Insulin Dose Decision-Support Tool",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Hussain Alsaffar, FACE, MSc, FRCPCH, CCT, MBChB","CONTACT","0096896399402","hussaina@squ.edu.om",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Nandu Kumar Thalange, Professor","00971589466920","n.thalange@genesis-dubai.com",[38,55],{"facility":39,"status":40,"city":41,"state":18,"zip":18,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of Mosul","RECRUITING","Mosul","Iraq","IQ",{"type":45,"coordinates":46},"Point",[47,48],43.11889,36.335,{"lat":48,"lon":47},[51],{"name":52,"role":30,"phone":53,"phoneExt":18,"email":54},"Dr Farah Othman, MBBS","009647703833560","fsy@uomosul.edu.iq",{"facility":56,"status":40,"city":57,"state":18,"zip":18,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University Child Hospital","Lahore","Pakistan","PK",{"type":45,"coordinates":61},[62,63],74.35071,31.558,{"lat":63,"lon":62},[66],{"name":67,"role":30,"phone":68,"phoneExt":18,"email":69},"Dr Sommayya Aftab, MBBS","+923314941549","sommayyaaftab@gmail.com",{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dr. Hussain Al Saffar","Principal Investigator",[75,76],{"name":39,"class":6},{"name":77,"class":6},"University of Child Health Sciences and Children's Hospital, Lahore","100625784","pediatric-insulin-plan-calculator-for-t1dm-management-100625784",false,"NCT07427134","Pediatric Insulin Plan Calculator for T1DM Management","Prospective, Parallel-Group Randomised Controlled Trial Evaluating a Flexible Insulin Dose Calculator in Paediatric Type 1 Diabetes Management","FLEXI-T1D","Inclusion Criteria:\n\n* Children and adolescents \\\u003C 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)","ALL","1 Year","12 Years",{"count":90,"type":91},440,"ESTIMATED","INTERVENTIONAL",[94],"NA","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\u002Fkg\u002Fday), 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.",[97,98,99,100],"Type 1 Diabetes Mellitus","Type 1 Diabetes Mellitus (T1DM)","T1DM","T1DM - Type 1 Diabetes Mellitus",[97,102,103,104],"Clinical Decision Support Tool","Digital Health Intervention","Insulin Dose Calculator","2026-06-06",{"date":107,"type":108},"2026-06-09","ACTUAL",{"date":110,"type":108},"2026-05-03",{"date":112,"type":91},"2026-12-31",{"name":5,"class":6},2]