HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes
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
- Diabetes Mellitus Type 1
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Air Liquide Healthcare Spain
- Enrolment target
- 80
- Started
- 22 April 2026
- Main results due
- May 2028
- Study sites
- 3
- Registry updated
- 29 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility 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).
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(3)
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
Showing 3 of 3 sites. 1 of the 3 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07492992. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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