HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring… (NCT07492992) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes
Spain80 participantsStarted 2026-04
Plain-language summary
The goal of this observational study is to evaluate a new home-based setup and care model for an advanced hybrid closed-loop insulin pump system (Tandem with Control-IQ). The study will look at the safety, effectiveness, costs, and impact on quality of life in adults with type 1 diabetes.
The main questions it aims to answer are:
* Is it safe for participants to start using the insulin pump system at home instead of the hospital? (Measured by the amount of time blood sugar is very low, under 54 mg/dL).
* Does this home-based care model help participants keep their blood sugar in a healthy range?
* How does this model affect the participants' quality of life, device satisfaction, and overall experience?
* Does this model reduce healthcare costs and the need for hospital visits?
Participants will:
* Complete an online technical training course before the setup.
* Receive a home visit from a specialized nurse to configure and start the insulin pump system.
* Have their device data monitored remotely every 14 days by the nursing team to manage any health alerts.
* Attend scheduled clinical follow-up visits at 1, 3, 6, and 12 months.
* Answer surveys about their quality of life, their experience with the healthcare service, and their satisfaction with the new device.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.