INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED): a study protocol for a randomised, double-blind, placebo-controlled clinical trial in children and adolescents with recent-onset type 1 diabetes.

INTRODUCTION: Children and adolescents with recent-onset type 1 diabetes (T1D) commonly maintain a certain level of insulin production during the remission phase, which can last months to years. Preserving ß-cell function can reduce T1D complications and improve glycaemic control. Influenza vaccination has pleiotropic effects and administration of the vaccine during the early phases of T1D may offer ß-cell protection. This study aims to assess the effect of influenza vaccination on preserving ß-cell function in children and adolescents with recent-onset T1D. METHODS AND ANALYSIS: The INfluenza VaccInation To mitigate typE 1 Diabetes trial is a randomised, double-blind, placebo-controlled, multicentre trial in paediatric patients with recent-onset T1D aged 7-17 years. 100 participants will be randomised in a 1:1 ratio to receive either a standard inactivated quadrivalent influenza vaccine or a placebo within 14 days of diagnosis. The primary outcome is a difference in mean change (from baseline to 12 months) in C-peptide level between groups during a 2-hour mixed-meal tolerance test. Secondary outcomes include mean change (from baseline to 6 months) in C-peptide levels, haemoglobin A1c, ambulatory glucose profiles and insulin requirements. Exploratory outcomes are diabetes-related autoantibodies, inflammatory markers and serum haemagglutinin inhibition antibody titres against the influenza viruses. The current treatment for T1D is largely symptomatic, relying on insulin administration. There is a pressing need for novel pharmacological approaches aimed at modulating the immune system to preserve residual ß-cell function. Existing immunotherapies are cost-prohibitive and associated with multiple side effects, whereas influenza vaccination is inexpensive and generally well tolerated. A positive outcome of this study holds potential for immediate implementation into standard care for children and adolescents with recent-onset T1D and may guide future research on immune modulation in T1D. ETHICS AND DISSEMINATION: Ethical approval was obtained from Danish Health Authorities prior to participant enrollment. The trial results will be submitted to a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT05585983 and EudraCT Number 2022-500906-17-01.

"They look into our world" - A qualitative study of intensive support to adolescents with poorly regulated type 1 diabetes and their families.

OBJECTIVE: This article is based on a qualitative evaluation of a project offering intensive support to Danish adolescents with poorly regulated type I diabetes and their families. The article explores 1) how the project allowed for another approach to the families than what is possible in usual care at the hospital, and 2) how the nurse involved other professionals in caring for the adolescents. METHODS: The study involved interviews with four participating adolescents, four parents, a social worker, and the nurse running the project, along with a reading of the nurse's entries in the adolescents' electronic patient records. Data was analyzed within the framework of realistic evaluation. RESULTS: The findings showed that key mechanisms in the nurse's work was her open and flexible approach to the families, the way she anchored conversations about diabetes in here and now situations, and her efforts at engaging teachers, social and health care professionals in helping the adolescents. CONCLUSION: The strengths of the project were the nurse's special approach to the families and her ability to engage other professionals. PRACTICE IMPLICATIONS: A care manager providing individualized and flexible help can have positive results on the treatment of adolescents with poorly regulated type 1 diabetes.