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
Sponsor: Air Liquide Healthcare Spain
Trial Details
| Condition | Diabetes Mellitus Type 1 |
| Status | Not_yet_recruiting |
| Participants | 80 |
| Est. Completion | 1 Apr 2028 |
| Last Updated | 13 Apr 2026 |
Primary Outcome
Percentage of Time Below Range (TBR) <54 mg/dL
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * 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 Criteria: * 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).
Trial Sites
Countries
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