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.
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.
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).
The study population consists of adults with type 1 diabetes receiving routine clinical care at public hospitals located in the Region of Murcia, Spain. To minimize selection bias, eligible patients will be invited to participate consecutively as they are identified as candidates for AHCL initiation during routine clinical practice.
Cohort
Prospective
Not listed
Percentage of Time Below Range (TBR) <54 mg/dL
Safety of the home-based initiation model is evaluated as the percentage of CGM time spent strictly below 54 mg/dL at the primary assessment time point of 12 months, analysed as a continuous variable. Results are interpreted with reference to the internationally recommended consensus target of \<1% as a clinical interpretive benchmark.
Percentage of Time in Range (TIR) 70-180 mg/dL
Clinical effectiveness will be characterised by measuring the percentage of time participants spend with sensor glucose levels between 70 and 180 mg/dL, as recorded by the continuous glucose monitoring (CGM) system.
Percentage of Time Above Range (TAR)
Clinical effectiveness will be evaluated by measuring the percentage of time participants spend with sensor glucose levels above 180 mg/dL (Level 1 and 2 hyperglycemia), as recorded by the continuous glucose monitoring (CGM) system
Change in Glycated Hemoglobin (HbA1c) Levels
Clinical effectiveness will be assessed by measuring the change in HbA1c percentage from baseline to evaluate long-term glycemic control
Mean Sensor Glucose
Mean glucose level (mg/dL) measured by the continuous glucose monitoring (CGM) system
Healthcare Professionals Acceptance and Experience
Acceptance and experience of the participating doctors and nurses regarding the home-based initiation model will be evaluated using a study-specific, ad hoc questionnaire. This custom tool is developed by the scientific committee and includes neutral Likert-type items and free-text questions for qualitative analysis. Because it is a custom ad hoc tool, it does not yield a single standardized global score; instead, results will be reported descriptively.
Healthcare Professionals' Perceptions of Time and Resource Use
Estimation of the clinical time saved in consultations and avoided visits, as perceived by the participating doctors and nurses, will be evaluated using a study-specific, ad hoc questionnaire currently under development by the scientific committee. This custom tool will list specific clinical tasks where the home-based model may liberate time, and will include free-text questions. Because it is a custom ad hoc tool in development, it will not yield a single standardized global score on a scale; instead, results will be reported descriptively.
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