NCT07492992Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- 22 Apr 2026
- Primary completion date
- May 2028
- Lead sponsor
- Air Liquide Healthcare Spain
- Diseases
- Type 1 diabetes
- NCT number
- NCT07492992
What you commit to
- Study type: Observational
- Planned participants: 80
- From 22 Apr 2026 to the primary completion date, May 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Lab values
- Medical contraindication for the use of insulin pumps or continuous glucose monitors (CGM).
Other
- Pregnant or planning to become pregnant during the study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital General Universitario Santa Lucia Coordinator of this site? Confirm its status | Cartagena | Spain | Recruiting |
| Hospital General Universitario Reina Sofía Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.