Starting an automated insulin pump system at home in adults with type 1 diabetes
Follows adults with type 1 diabetes starting an automated insulin pump at home.
Plain-language title generated from the registry record
Registry title: HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes
Key facts
- Where
- Cartagena and Murcia, SpainSee the 3 sites
Where in Spain
- Hospital General Universitario Santa LuciaCartagena, SpainTaking people
- Hospital Clínico Universitario Virgen de la ArrixacaMurcia, SpainNot yet recruiting
- Hospital General Universitario Reina SofíaMurcia, SpainNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Air Liquide Healthcare Spain
- Trial code
- NCT07492992
- Record updated
- 29 September 2026
- Original description
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.Read full original descriptionShow less
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
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.
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; 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); Pregnant or planning to become pregnant during the study.