NCT07492992
HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes
Recruiting · Not specified · Air Liquide Healthcare Spain · registry updated 2026-09-29
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- Diagnosis of type 1 diabetes.
- Aged 18 years or older.
- Candidate to initiate an Advanced Hybrid Closed-Loop (AHCL) system based on standard clinical criteria.
- Access to the internet and/or a compatible smartphone to connect to the system.
- Willingness to participate in the study and sign the informed consent form.
Exclusion
- Currently participating in another diabetes-related clinical trial.
- Pregnant or planning to become pregnant during the study.
- Inability to use the system autonomously (e.g., severe cognitive impairment or severe psychiatric disorders without support).
- Medical contraindication for the use of insulin pumps or continuous glucose monitors (CGM).