1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response (Others) -  In case, the protocol is published. It will include all the above mention information
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  Data will be presented as a, results in publication only. NO individual data will be shared. That will include with mean/median age of the participants, their demographic and glycaemic outcome and change in HbA1c at 3 and 6 months of the study


6. For how long will this data be available start date provided 01-06-2030 and end date provided 01-06-2033?
   Response (Others) -  It will be presented in publication only


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Impact of the 4T (teamwork, target, technology, tight control) intervention on glycaemic outcomes among children and youth with type 1 diabetes in Ahmedabad, India

Abstract

Background: India has the highest estimated number of prevalent and incident cases of Type 1 Diabetes (T1D) in children and youth globally. Despite the benefits of intensive glucose control, translation into clinical practice remains limited.Objective: To assess HbA1c outcomes during the first year of diagnosis in children and youth with T1D by adopting the Stanford 4T model.

Hypothesis: Early use of Continuous Glucose Monitoring (CGM) within one year of diagnosis will significantly improve HbA1c levels and Increase Time-in-Range (TIR) compared to traditional monitoring.

Primary & Secondary Outcomes

• Primary Outcome: Optimal reduction of HbA1c (<7.5% from baseline) within 6 months of the study. 

• Secondary Outcomes: * Reduction in hospitalizations due to Diabetic Ketoacidosis (DKA).

• Increased Time-in-Range (TIR) and reduced glycemic variability.

• Lowered frequency of moderate and severe hypoglycemia.

• Improved psychological measures (reduced diabetes-related distress) and high CGM satisfaction.

• 4. Study Design & Methodology

• Type of Study: Randomized Controlled Trial (RCT).

• Allocation: 1:1 ratio using a computer-generated randomization sequence.

• Participants: Children and youth <18 years old diagnosed with T1D within one year of their clinical visit.

• Sample Size: 106 participants total (53 in the intervention arm, 53 in the control arm).

• Intervention: Use of the LinX CGM system (Bluetooth-enabled) paired with a phased education model involving virtual and face-to-face consultations.

• Control: Regular patient consultations and education every 3 months without virtual consultations or CGM.

• 5. Recruitment & Setting The study will be conducted at tertiary diabetes centers in Ahmedabad, India. Referral partnerships with public and private hospitals will be established to ensure rapid identification of new-onset cases.

• 6. Ethical Considerations Consent: Written informed consent will be obtained from parents (for those <13 years) and assent/consent from adolescents (14–18 years).

• Sponsors: International Society for Pediatric and Adolescent Diabetes (ISPAD) and Breakthrough T1D.