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 observational study is to evaluate a new home-based setup and care model for an advanced hybrid closed-loop insulin pump system (Tandem with Control-IQ). The study will look at the safety, effectiveness, costs, and impact on quality of life in adults with type 1 diabetes. The main questions it aims to answer are: * Is it safe for participants to start using the insulin pump system at home instead of the hospital? (Measured by the amount of time blood sugar is very low, under 54 mg/dL). * Does this home-based care model help participants keep their blood sugar in a healthy range? * How does this model affect the participants' quality of life, device satisfaction, and overall experience? * Does this model reduce healthcare costs and the need for hospital visits? Participants will: * Complete an online technical training course before the setup. * Receive a home visit from a specialized nurse to configure and start the insulin pump system. * Have their device data monitored remotely every 14 days by the nursing team to manage any health alerts. * Attend scheduled clinical follow-up visits at 1, 3, 6, and 12 months. * Answer surveys about their quality of life, their experience with the healthcare service, and their satisfaction with the new device.

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

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