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Clinical Trials in Spain / NCT07492992
Recruiting Observational

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

NCT07492992 · tracked via the Priya Life Science Spain tracker
Sponsor
Air Liquide Healthcare Spain
Phase
Observational
Started
2026-04-22
Last updated
2026-09-29

Condition(s) studied

Diabetes Mellitus Type 1

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Percentage of Time Below Range (TBR) <54 mg/dL — Month 12
    Safety of the home-based initiation model is evaluated as the percentage of CGM time spent strictly below 54 mg/dL at the primary assessment time point of 12 months, analysed as a continuous variable. Results are interpreted with reference to the internationally recommended consensus target of \<1% as a clinical interpretive benchmark.

Trial sites (3)

FacilityCityRegionStatus
Hospital General Universitario Santa Lucía Cartagena Murcia Recruiting
Hospital General Universitario Reina Sofía Murcia Murcia Not Yet Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca Murcia Murcia Not Yet Recruiting

More Air Liquide Healthcare Spain trials in Spain

Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07492992 on ClinicalTrials.gov ↗ ← All trials in Spain