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.
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 will be evaluated by measuring the percentage of time participants spend with sensor glucose levels strictly below 54 mg/dL (Level 2 hypoglycemia), as recorded by the continuous glucose monitoring (CGM) system
Percentage of Time in Range (TIR) 70-180 mg/dL
Clinical effectiveness will be evaluated 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
Percentage of Time in Tight Range (TITR) 70-140 mg/dL
Clinical effectiveness will be evaluated by measuring the percentage of time participants spend with sensor glucose levels between 70 and 140 mg/dL, 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
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 Estimation of Efficiency and Saved Time
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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