Improving diabetes Outcomes among youth with type 1 diabetes in Ahmedabad, India: Adoption of the 4T (Teamwork, Targets, Technology, and Tight Control) Program from Stanford, United States

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 & SettingThe 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.