Clinical Trial Radar

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

Baseline, Month 1, Month 3, Month 6, and Month 12

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.

Baseline, Month 1, Month 3, Month 6, and Month 12

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

Baseline, Month 1, Month 3, Month 6, and Month 12

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

Baseline, Month 1, Month 3, Month 6, and Month 12

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

Baseline and Month 12

Mean Sensor Glucose

Mean glucose level (mg/dL) measured by the continuous glucose monitoring (CGM) system

Baseline, Month 1, Month 3, Month 6, and Month 12

Glycemic Variability Assessed by Coefficient of Variation (CV)

Percentage of the coefficient of variation of sensor glucose levels, used as a measure of glycemic variability

Baseline, Month 1, Month 3, Month 6, and Month 12

Total Insulin Units Consumed

Total daily units of insulin consumed by the participant via the advanced hybrid closed-loop system

Baseline, Month 1, Month 3, Month 6, and Month 12

Percentage of Time With Active System

Percentage of time the advanced hybrid closed-loop system is active and operating in closed-loop model

Baseline, Month 1, Month 3, Month 6, and Month 12

Incidence of Severe Hypoglycemia

Number of severe hypoglycemia episodes requiring assistance from another person during the follow-up period

12 months

Incidence of Diabetic Ketoacidosis (DKA)

Number of episodes of diabetic ketoacidosis and related hospital admissions during the follow-up period

12 months

Change in Quality of Life Assessed by the ViDa1 Questionnaire

Quality of life will be measured using the ViDa1 (Vida con Diabetes tipo 1) questionnaire, a specific instrument validated in Spain for adults with Type 1 Diabetes. It assesses 4 dimensions: interference with life, self-care, well-being, and disease worry

Baseline, Month 3, Month 6, and Month 12

Change in Diabetes Distress Assessed by the PAID-20 Questionnaire

Disease burden and diabetes-related emotional distress will be measured using the 20-item Problem Areas in Diabetes (PAID-20) scale. Higher scores indicate greater emotional distress related to diabetes management

Baseline, Month 3, Month 6, and Month 12

Health-Related Quality of Life Assessed by the EQ-5D-5L Questionnaire

General health-related quality of life will be measured using the EQ-5D-5L questionnaire, evaluating mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses will be used to calculate the EQ-Index (scale 0-1, where 1 is perfect health) to estimate Quality-Adjusted Life Years (QALYs) gained

Baseline, Month 1, Month 3, Month 6, and Month 12

Patient Experience Assessed by the howRwe Questionnaire

Patient experience regarding the healthcare service and the home-based initiation model will be evaluated using the generic howRwe questionnaire, which assesses the patient-staff relationship and overall system functioning

Month 1, Month 3, Month 6, and Month 12

Device Satisfaction Assessed by the Diabetes Impact and Device Satisfaction Scale (DIDS)

Patient satisfaction with the technology and the impact of the treatment will be measured using the DIDS questionnaire, which assesses satisfaction and impact domains related to the advanced hybrid closed-loop system

Baseline, Month 3, Month 6, and Month 12

Cost-Utility Indicator: Quality-Adjusted Life Years (QALYs) Accumulated

The cost-utility indicator will be evaluated using the total direct medical costs and the QALYs accumulated over the follow-up period. QALYs will be calculated using the EQ-5D-5L questionnaire index scores based on validated tariffs. Since the study lacks a comparator group, any estimation of "QALYs gained" will be conducted explicitly as an exploratory analysis, using a before-after counterfactual compared against the patient's own baseline state.

12 months

Direct Healthcare Costs and Resource Consumption

The economic impact the home-based initiation model will be evaluated by quantifying total direct healthcare costs from the perspective of the Healthcare System. This includes the consumption of resources such as scheduled and unscheduled primary care visits, emergency room visits, hospital admissions, and specialized endocrinology consultations.

12 months