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

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.

NCT Number	NCT07492992
Lead Sponsor	Air Liquide Healthcare Spain
Conditions	Diabetes Mellitus Type 1
Enrollment	80 participants
Start Date	2026-04
Primary Completion	2028-04 (estimated)
Study Completion	2028-04 (estimated)
Updated on ClinicalTrials.gov	2026-04-13