HOME-AHCL: Home-Based Implementation of an Advanced Hybrid Closed-Loop System With Telemonitoring in Type 1 Diabetes
HOME-AHCL
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
1 other identifier
observational
80
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2026
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2026
CompletedFirst Posted
Study publicly available on registry
March 25, 2026
CompletedStudy Start
First participant enrolled
April 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
September 29, 2026
September 1, 2026
2 years
March 20, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Month 12
Secondary Outcomes (15)
Percentage of Time in Range (TIR) 70-180 mg/dL
Baseline, Month 1, Month 3, Month 6, and Month
Percentage of Time Above Range (TAR)
Baseline, Month 1, Month 3, Month 6, and Month 12
Change in Glycated Hemoglobin (HbA1c) Levels
Baseline and Month 12
Mean Sensor Glucose
Baseline, Month 1, Month 3, Month 6, and Month 12
Glycemic Variability Assessed by Coefficient of Variation (CV)
Baseline, Month 1, Month 3, Month 6, and Month
- +10 more secondary outcomes
Other Outcomes (2)
Healthcare Professionals Acceptance and Experience
Month 12
Healthcare Professionals' Perceptions of Time and Resource Use
Month 12
Study Arms (1)
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
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202, Spain
Hospital General Universitario Reina Sofía
Murcia, Murcia, 30003, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Georgios Kyriakos
Hospital General Universitario Santa Lucía, Cartagena
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2026
First Posted
March 25, 2026
Study Start
April 22, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
September 29, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share