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HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes

Study acronym: HOME-AHCL
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Recruitment opened Show 8 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Study completion pushed from Apr 2028 to Sep 2028
    • Study sites: 1 to 3
    • Primary completion date: Apr 2028 to May 2028
    • Start date changed from estimate of Apr 2026 to Apr 22, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: 17 to 15
    • Study description shortened, about 52 words
  2. Enrollment increased: 25 → 80 participantsv3
  3. Secondary endpoints: details revised at 5 of 17 entriesv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07492992
Lead Sponsor Air Liquide Healthcare Spain
Conditions
(from sponsor)		 Diabetes Mellitus Type 1
Related terms Diabetes Mellitus, Type 1
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov