DiabetesFlex™ – the effect of PRO-based telehealth and user involvement in care management of patients with type 1 diabetes: Trial protocol for a non-inferiority randomised controlled study

Background: This trial focuses on management of care for patients with type 1 diabetes, patient involvement and use of patient-reported outcome (PRO)-based telehealth. Despite available knowledge on the use of different kinds of PRO measures in diabetes care, studies that use PRO in remote monitoring in diabetes management are scarce. Objective: The aim of this pragmatic randomised controlled non-inferiority study is to investigate the effect using a PRO-based telehealth intervention, DiabetesFlex, on health outcome, user involvement and healthcare utilisation in patients with type 1 diabetes. Methods: This trial plans to recruit 400 patients with type 1 diabetes treated at an outpatient clinic at XXXX University Hospital. The participants will fill in an electronic questionnaire covering health outcome and patient involvement at baseline and at end of the study period (15 month). Data on HbA1c, blood pressure, urine albumin/creatinine ratio and resource (number of contacts and consultations) will be drawn from the patients’ medical records at baseline and at 4, 8, 12 and 15 months. Patients will be randomised to either DiabetesFlex™ (a patient-initiated and PRO-driven protocol) or standard care. The patient perspective on the use of DiabetesFlex™ will be explored in a qualitative study. Conclusion: This study will seek to outline significant knowledge on what matters to the people with diabetes in relation to involvement in care planning. As well as factors related to patients’ experiences concerning the use of PRO measures. This is important components in diabetes care management. Trial registration: ClinicalTrials.gov. NCT03202732