HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes
brief 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.
detailed description
Background and Rationale: The standard model for initiating Advanced Hybrid Closed-Loop (AHCL) systems in Spain is primarily hospital-centric. This model consumes significant healthcare resources and can lead to variability in access or delays in treatment indication. The Region of Murcia currently has a higher hospitalization rate for Type 1 Diabetes (T1D) than the national average, suggesting room for improvement in care organization. This project proposes an alternative Value-Based Healthcare (VBHC) model that shifts the initiation of the Tandem Control-IQ system to the patient's home, supported by structured online education, continuous telemonitoring, and shared clinical follow-up between the hospital and a specialized external nursing team.
Study Pathway and Procedures: Eligible patients will first undergo online technical training on the AHCL system provided by a specialized nurse. Subsequently, the nurse will perform the physical setup of the system at the patient's home, configuring the device according to the medical parameters (e.g., basal rates, sensitivity factors, carbohydrate ratios) prescribed by the patient's endocrinologist. Sampling Method: Eligible participants will be selected using consecutive participant sampling to minimize selection bias.
Throughout the 12-month follow-up, patients will be telemonitored every 14 days. The external nursing team will review glycemic metrics to identify automated clinical alerts. High alerts (defined as Time in Range \[TIR\] \<=50% or Time Below Range \[TBR\] \>=8%) and Medium alerts will trigger a telephone intervention. Technical issues will be resolved directly by the specialized nurses, while persistent clinical issues will trigger a protocolized referral back to the hospital's endocrinology team. Scheduled data collection for clinical indicators, questionnaires, and resource consumption will occur at baseline, and at 1, 3, 6, and 12 months.
Healthcare Professionals Sub-study: A parallel evaluation will involve the participating doctors and nurses (approximately 9 physicians and 3 nurses). They will complete specific, anonymized questionnaires halfway through the study to assess their acceptance of the model, perceived experience, and the estimated time saved in hospital consultations and avoided emergency visits due to the home-based model.
Data Management and Quality Assurance: Data will be prospectively collected using an electronic Case Report Form (e-CRD) hosted on a secure, centralized cloud clinical platform (ReseaArch). The system is designed with filters and restrictions to minimize data entry errors, flag out-of-range values, and detect inconsistencies.
official title
Safety, Effectiveness, Quality of Life, Costs, and Efficiency of the Home Setup of the Hybrid Closed-Loop System in People With Type 1 Diabetes: Application of a Value-Based Diabetes Management Model