An observational study in Diabetes Mellitus Type 1, sponsored by Air Liquide Healthcare Spain. Recruiting at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Air Liquide Healthcare Spain · Observational
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:
Participants will:
The standard model for initiating Advanced Hybrid Closed-Loop (AHCL) systems in Spain is primarily hospital-centric, consuming significant healthcare resources and creating potential bottlenecks in patient access. In the Region of Murcia, high diabetes-related hospitalisation rates suggest an opportunity to optimise care delivery. The HOME-AHCL study evaluates an alternative care-delivery pathway that shifts the initiation of the Tandem Control-IQ system to the patient's home, supported by structured online education, 14-day telemonitoring with automated alerts, and shared follow-up between hospital endocrinology teams and a specialised diabetes technology care team (Novalab).
Study Pathway and Procedures:
Study activities initiated in April 2026 following ethics committee approval. The first participant signed written informed consent on 22 April 2026, and the first device was activated (Day 0) on 14 May 2026, marking the start of a 12-month staggered recruitment period planned to conclude in May 2027 (14 May 2027).
Eligible adults with type 1 diabetes undergo online technical training provided by a specialised nurse prior to system activation. The nurse subsequently conducts a home visit on Day 0 for device setup according to parameters prescribed by the hospital endocrinologist. Participants are monitored remotely every 14 days throughout the 12-month follow-up. Continuous glucose monitoring (CGM) data are reviewed fortnightly to classify automated alerts based on predefined criteria: High alerts (TIR ≤50% or TBR \<70 mg/dL ≥8%), Medium alerts (TIR >50% to \<70% or TBR \<70 mg/dL >4% to \<8%), and No alert (TIR ≥70% and TBR \<70 mg/dL ≤4%). Medium or High alerts trigger a protocolised telephone triage by specialised nurses. Technical issues are resolved directly, while persistent clinical issues are referred back to the hospital team. Scheduled data collection occurs at baseline, and at months 1, 3, 6, and 12.
Healthcare Professionals Sub-study:
Participating physicians and nurses will complete two study-specific, ad hoc questionnaires when approximately 50% of participants complete 12-month follow-up. Questionnaire 1 assesses model acceptance and feasibility; Questionnaire 2 evaluates healthcare professionals' perceptions regarding clinical time allocation and estimated resource impacts. These estimates are interpreted strictly as professional perceptions rather than objectively recorded comparative healthcare utilization data.
Data Management and Quality Assurance:
Data are prospectively collected using an electronic Case Report Form (e-CRF) hosted on the secure cloud platform ReseaArch® (Persei Vivarium, S.L.) under joint-controller GDPR compliance. Re-identification keys remain under the exclusive custody of site investigators. Missing data are expected to be minimal due to automated CGM cloud synchronization and monthly database audits.
Sample Size Assessment:
The planned sample comprises 80 participants. Assuming up to a 15% attrition rate, approximately 68 participants are expected to contribute complete 12-month primary outcome data. Given the descriptive nature of this single-arm study, statistical adequacy is based on estimation precision for the primary safety outcome: Time Below Range (TBR \<54 mg/dL at Month 12). Assuming a conservative standard deviation of 0.65 percentage points (based on real-world PLGS baseline variability), N=68 provides a 95% confidence interval precision (half-width) of approximately +/-0.15 percentage points around the mean TBR \<54 mg/dL.
Statistical Analysis Plan:
Baseline characteristics will be summarized using descriptive statistics. Longitudinal outcomes across follow-up time points (M1, M3, M6, M12) will be evaluated using mixed-effects models under the Missing at Random (MAR) assumption: Linear Mixed Models (LMM) with AR(1) or Compound Symmetry covariance structures (selected by AIC) for continuous CGM and PROM/PREM metrics, and Generalized Linear Mixed Models (GLMM) with a logit link function for dichotomous consensus targets. Centre, sex, age, duration of diabetes, and baseline BMI will be considered as prespecified potential fixed-effect covariates in adjusted analyses; their inclusion in individual models will depend on their clinical relevance to the outcome and on whether they can be meaningfully estimated given the available data. Because all participants transition systematically from FreeStyle Libre 2 at baseline to Dexcom G7 upon AHCL initiation, baseline-to-follow-up CGM comparisons are considered exploratory due to platform-time confounding; post-initiation longitudinal analyses utilize Dexcom G7 metrics exclusively. Accumulated QALYs (derived from EQ-5D-5L) will be reported descriptively within the cohort. Post-hoc pairwise comparisons will be adjusted using Bonferroni correction.
Cost Analysis:
Resource utilization (consultations, emergency visits, admissions, consumables) will be measured and valued using official regional tariffs. This allows to conduct a cost analysis from the public healthcare system perspective (Servicio Murciano de Salud), considering direct medical costs over a 1-year time horizon, and thus without discounting. In the absence of a concurrent comparator, no incremental cost analysis or economic evaluation (such as cost/effectiveness analysis) will be performed.
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.
Exclusion Criteria:
Adults with type 1 diabetes initiating the advanced hybrid closed-loop system (Tandem Control-IQ) in a home-based setting
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.
Time frame: Month 12
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.
Time frame: Baseline, Month 1, Month 3, Month 6, and Month
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
Time frame: 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
Time frame: Baseline and Month 12
Mean Sensor Glucose
Mean glucose level (mg/dL) measured by the continuous glucose monitoring (CGM) system
Time frame: 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
Time frame: Baseline, Month 1, Month 3, Month 6, and Month
Total Insulin Units Consumed
Total daily units of insulin consumed by the participant via the advanced hybrid closed-loop system
Time frame: 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
Time frame: 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
Time frame: 12 months
Incidence of Diabetic Ketoacidosis (DKA)
Number of episodes of diabetic ketoacidosis and related hospital admissions during the follow-up period
Time frame: 12 months
Change in Quality of Life Assessed by the ViDa1 Questionnaire
Quality of life will be measured using the unabbreviated scale Vida con Diabetes tipo 1 (ViDa1) questionnaire, a specific instrument validated in Spain for adults with type 1 diabetes. The questionnaire consists of 34 items rated on a 5-point Likert scale (from 1 = strongly disagree to 5 = strongly agree). Scores are calculated by summing the items for each of its 4 dimensions: * Interference with life (12 items): Score ranges from 12 to 60. Higher scores indicate greater interference with daily life (a worse outcome). * Self-care (11 items): Score ranges from 11 to 55. Higher scores indicate better disease self-care (a better outcome). * Well-being (6 items): Score ranges from 6 to 30. Higher scores indicate greater physical and psychological well-being (a better outcome). * Disease worry (5 items): Score ranges from 5 to 25. Higher scores indicate greater fear and worry about the disease (a worse outcome).
Time frame: 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 unabbreviated scale, the Problem Areas In Diabetes (PAID) questionnaire. The questionnaire consists of 20 items, each rated from 0 (not a problem) to 4 (a serious problem). The scores for each item are summed and then multiplied by 1.25 to generate a total score. The total score ranges from a minimum value of 0 to a maximum value of 100. Higher scores indicate severe diabetes distress, representing a worse outcome
Time frame: 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 unabbreviated scale, the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The instrument consists of two parts. First, a descriptive system evaluating 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), which are used to calculate the EQ-Index score based on validated tariffs. The EQ-Index score ranges from a minimum value of 0 to a maximum value of 1. Second, a Visual Analogue Scale (VAS) rating current overall health, ranging from a minimum value of 0 (worst health you can imagine) to a maximum value of 100 (best health you can imagine). For both the EQ-Index and the VAS, higher scores indicate better health, representing a better outcome. Quality-adjusted life years (QALYs) will be calculated based on the EQ-Index score.
Time frame: 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 unabbreviated scale, the howRwe (How are we doing) questionnaire, which assesses the patient-staff relationship and overall system functioning. The questionnaire consists of 4 items, each rated on a 4-point scale from 0 (poor) to 3 (excellent). The scores for each item are summed to generate a total summary score. The total score ranges from a minimum value of 0 to a maximum value of 12. Higher scores indicate a better patient experience with the healthcare service, representing a better outcome
Time frame: 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 psychosocial impact of the treatment will be measured using the unabbreviated scale, the Diabetes Impact and Device Satisfaction (DIDS) Scale. The instrument consists of 11 items, each rated on a 10-point Likert scale. It is scored by calculating the mean of the items for its two subscales: * Device Satisfaction (7 items): The score ranges from a minimum value of 1 to a maximum value of 10. Higher scores indicate greater satisfaction with the insulin delivery device, representing a better outcome. * Diabetes Impact (4 items): The score ranges from a minimum value of 1 to a maximum value of 10. Higher scores indicate a greater negative impact of diabetes on the user's daily life (e.g., worry, sleep interruptions), representing a worse outcome.
Time frame: Baseline, Month 3, Month 6, and Month 12
Resource Consumption and Costs
A cost analysis will be conducted by applying the unit cost to each resource used, based on the monetary value assigned by the Murcia Health Service. This includes the consumption of resources such as scheduled and unscheduled primary care visits, emergency room visits, hospital admissions, and specialized endocrinology consultations. The total cost will be the sum of the aggregated costs of each resource used. Therefore, this is a cost analysis considering only direct costs from the payer (the healthcare system) perspective. As the time horizon is one year, no discounting will be applied.
Time frame: 12 months
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.
Time frame: Month 12
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.
Time frame: Month 12
Plan to share: No
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Air Liquide Healthcare Spain