Diabetes Mellitus Type 1HOME-AHCLNCT07492992
HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes
An observational study of Diabetes Mellitus Type 1, run by Air Liquide Healthcare Spain at 3 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Type 1
- How many people
- 80 participants
- Where
- 3 sitesSpain
- Study dates
- 22 Apr 2026to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Willingness to participate in the study and sign the informed consent form.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Carla Yago-Díez contact
Spain3 sites, 3 recruiting
- Recruiting
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
Georgios Kyriakos, +34 968 12 86 00, georgios.kyriakos@carm.es
- Not yet recruiting
Hospital General Universitario Reina Sofía
Murcia, Murcia, 30003
Cristina del Peso Gilsanz, +34968 21 77 62 ext. 911124, cristina.delpeso@carm.es
- Not yet recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
Aurora Aragón Alonso, +34968299087, auroaragon@yahoo.es
About this study
Official title: Safety, Glycaemic Outcomes, Quality of Life, Costs, and Healthcare Resource Use of the Home Setup of the Hybrid Closed-Loop System in People With Type 1 Diabetes: Application of a Value-Based Diabetes Management Model
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- Type 1 Diabetes, Advanced Hybrid Closed Loop, Insulin Pump, Continuous Glucose Monitoring, Telemonitoring, Remote Patient Monitoring, Value-Based Healthcare, Home Care Services, Quality of Life, Healthcare Resource Utilization, Partial Economic Evaluation
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AHCL-IQ Home-based Cohort | Adults with type 1 diabetes initiating the advanced hybrid closed-loop system (Tandem Control-IQ) in a home-based setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12
Secondary outcomes (15)
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.
Measured: 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
Measured: 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
Measured: Baseline and Month 12
Mean Sensor Glucose
Mean glucose level (mg/dL) measured by the continuous glucose monitoring (CGM) system
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Incidence of Diabetic Ketoacidosis (DKA)
Number of episodes of diabetic ketoacidosis and related hospital admissions during the follow-up period
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start22 Apr 2026
- Primary completionMay 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Liquide Healthcare Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georgios Kyriakos, Principal investigator, Hospital General Universitario Santa Lucía, Cartagena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492992
- Sponsor's protocol ID
- HOME-AHCL-DMT1
- Acronym
- HOME-AHCL
- Status last verified
- Sep 2026
- First submitted
- 20 Mar 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Glycaemic Outcomes, Quality of Life, Costs, and Healthcare Resource Use of the Home Setup of the Hybrid Closed-Loop System in People With Type 1 Diabetes: Application of a Value-Based Diabetes Management Model
- ClinicalTrials.gov ID
- NCT07492992
- Acronym / sponsor ID
- HOME-AHCL / HOME-AHCL-DMT1
- Conditions
- Diabetes Mellitus Type 1
- Keywords
- Type 1 Diabetes, Advanced Hybrid Closed Loop, Insulin Pump, Continuous Glucose Monitoring, Telemonitoring, Remote Patient Monitoring, Value-Based Healthcare, Home Care Services
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Air Liquide Healthcare SpainIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHCL-IQ Home-based Cohort | – | –Adults with type 1 diabetes initiating the advanced hybrid closed-loop system (Tandem Control-IQ) in a home-based setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
- Willingness to participate in the study and sign the informed consent form.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Time Below Range (TBR) <54 mg/dL
Time frame: Month 12
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.
15 secondary outcomes
Percentage of Time in Range (TIR) 70-180 mg/dL
Time frame: Baseline, Month 1, Month 3, Month 6, and Month
Percentage of Time Above Range (TAR)
Time frame: Baseline, Month 1, Month 3, Month 6, and Month 12
Change in Glycated Hemoglobin (HbA1c) Levels
Time frame: Baseline and Month 12
Mean Sensor Glucose
Time frame: Baseline, Month 1, Month 3, Month 6, and Month 12
Glycemic Variability Assessed by Coefficient of Variation (CV)
Time frame: Baseline, Month 1, Month 3, Month 6, and Month
Total Insulin Units Consumed
Time frame: Baseline, Month 1, Month 3, Month 6, and Month 12
Percentage of Time With Active System
Time frame: Baseline, Month 1, Month 3, Month 6, and Month 12
Incidence of Severe Hypoglycemia
Time frame: 12 months
Incidence of Diabetic Ketoacidosis (DKA)
Time frame: 12 months
Change in Quality of Life Assessed by the ViDa1 Questionnaire
Time frame: Baseline, Month 3, Month 6, and Month 12
Change in Diabetes Distress Assessed by the PAID-20 Questionnaire
Time frame: Baseline, Month 3, Month 6, and Month 12
Health-Related Quality of Life Assessed by the EQ-5D-5L Questionnaire
Time frame: Baseline, Month 1, Month 3, Month 6, and Month 12
Patient Experience Assessed by the howRwe Questionnaire
Time frame: Month 1, Month 3, Month 6, and Month 12
Device Satisfaction Assessed by the Diabetes Impact and Device Satisfaction Scale (DIDS)
Time frame: Baseline, Month 3, Month 6, and Month 12
Resource Consumption and Costs
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carla Yago-Díez contact
Georgios Kyriakos principal investigator
Hospital General Universitario Santa Lucía, Cartagena
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 1, run by Air Liquide Healthcare Spain at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Martínez Mateos (+34 690 283 723, maria.martinez-mateos@airliquide.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time Below Range (TBR) <54 mg/dL (time frame: Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.