Clinical Research Directory

HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes

Sponsor: Air Liquide Healthcare Spain

Summary

The goal of this prospective, single-arm observational study is to characterise a home-based setup and telemonitoring care model for an advanced hybrid closed-loop insulin pump system (Tandem Control-IQ) in adults with type 1 diabetes. The study characterises safety, glycaemic outcomes, direct healthcare costs, and impact on quality of life and user experience over 12 months. The main research questions are: * What is the safety profile of initiating the insulin pump system at home, measured by the percentage of sensor time spent below 54 mg/dL at 12 months? * What longitudinal changes in glycaemic metrics (such as Time in Range) are observed within the cohort following home-based initiation? * What changes in quality of life, technology satisfaction and healthcare experience are observed during follow-up? * What are the direct healthcare costs and resource utilization patterns associated with this care pathway from a public healthcare system perspective? Participants will: * Complete an online technical training course prior to system activation. * Receive a home visit from a specialised nurse to configure and start the insulin pump system. * Have their continuous glucose monitoring data reviewed remotely every 14 days by the nursing team to manage automated clinical alerts. * Attend scheduled clinical follow-up assessments at 1, 3, 6, and 12 months. * Complete questionnaires assessing quality of life, patient experience, and device satisfaction.

Official title: Safety, Glycaemic Outcomes, Quality of Life, Costs, and Healthcare Resource Use of the Home Setup of the Hybrid Closed-Loop System in People With Type 1 Diabetes: Application of a Value-Based Diabetes Management Model

Key Details

Conditions

Locations (3)