Home-based use of an advanced hybrid closed-loop insulin pump with telemonitoring for adults with type 1 diabetes
Official title: Safety, Glycaemic Outcomes, Quality of Life, Costs, and Healthcare Resource Use of the Home Setup of the Hybrid Closed-Loop System in People With Type 1 Diabetes: Application of a Value-Based Diabetes Management Model
Run by Air Liquide Healthcare Spain · NCT07492992 · Data updated 2026-11-12
This study tests whether starting an advanced hybrid closed-loop insulin pump at home, with online education and telemonitoring, is feasible and safe for adults with type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Air Liquide Healthcare Spain Industry-sponsored |
| Locations | 3 sites (Cartagena, Murcia and 2 other locations) |
| Status | Recruiting |
| Started | April 22, 2026 |
| Main results expected | May 2028 |
| Study ends | September 2028 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07492992 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with type 1 diabetes who are candidates for an advanced hybrid closed-loop system and have internet or smartphone access.
✕Probably not a fit
Individuals without internet access, those unable to autonomously operate the system, or those who do not meet clinical criteria for AHCL initiation may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm observational study in adults with type 1 diabetes to characterize a home-based initiation pathway for the Tandem Control-IQ system with telemonitoring over 12 months. It aims to describe safety (including sensor-time below 54 mg/dL), glycemic outcomes (e.g., time in range), quality of life and user experience, and direct healthcare costs from a public healthcare perspective. Training is delivered online by a specialized nurse, followed by a home setup and 14-day telemonitoring with hospital and diabetes technology team involvement. Data are reviewed regularly to guide automated alerts and care decisions. The study seeks to determine whether home initiation can reduce resource bottlenecks and improve access compared with hospital-centric initiation.
Why it matters
Potential benefit: If successful, patients may experience safer home initiation, improved access, and potential improvements in glycemic control and quality of life.
How similar studies have gone: Prior work suggests home-based or telemonitoring approaches can support CGM/loop therapy, but this specific home-initiation pathway for AHCL with telemonitoring is relatively novel and being evaluated.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
-
Hospital General Universitario Santa Lucía
Cartagena, Murcia, Spain Recruiting -
Hospital General Universitario Reina Sofía
Murcia, Murcia, Spain Not yet recruiting -
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain Not yet recruiting
Study contacts
- Principal investigator: Georgios Kyriakos — Hospital General Universitario Santa Lucía, Cartagena
- Study coordinator: María Martínez Mateos
- Email: maria.martinez-mateos@airliquide.com
- Phone: +34 690 283 723
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.