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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Percentage of Time Below Range (TBR) <54 mg/dL
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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
结局指标
主要结局
Percentage of Time Below Range (TBR) <54 mg/dL
时间窗: 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.
Percentage of Time Below Range (TBR) <54 mg/dL
时间窗: Baseline, Month 1, Month 3, Month 6, and Month 12
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
次要结局
- Health-Related Quality of Life Assessed by the EQ-5D-5L Questionnaire(Baseline, Month 1, Month 3, Month 6, and Month 12)
- Percentage of Time in Range (TIR) 70-180 mg/dL(Baseline, Month 1, Month 3, Month 6, and Month)
- Glycemic Variability Assessed by Coefficient of Variation (CV)(Baseline, Month 1, Month 3, Month 6, and Month)
- Resource Consumption and Costs(12 months)
- Change in Glycated Hemoglobin (HbA1c) Levels(Baseline and Month 12)
- Percentage of Time in Range (TIR) 70-180 mg/dL(Baseline, Month 1, Month 3, Month 6, and Month 12)
- Percentage of Time Above Range (TAR)(Baseline, Month 1, Month 3, Month 6, and Month 12)
- Percentage of Time in Tight Range (TITR) 70-140 mg/dL(Baseline, Month 1, Month 3, Month 6, 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 12)
- Total Insulin Units Consumed(Baseline, Month 1, Month 3, Month 6, and Month 12)
- Percentage of Time With Active System(Baseline, Month 1, Month 3, Month 6, and Month 12)
- Incidence of Severe Hypoglycemia(12 months)
- Incidence of Diabetic Ketoacidosis (DKA)(12 months)
- Change in Quality of Life Assessed by the ViDa1 Questionnaire(Baseline, Month 3, Month 6, and Month 12)
- Change in Diabetes Distress Assessed by the PAID-20 Questionnaire(Baseline, Month 3, Month 6, and Month 12)
- Patient Experience Assessed by the howRwe Questionnaire(Month 1, Month 3, Month 6, and Month 12)
- Device Satisfaction Assessed by the Diabetes Impact and Device Satisfaction Scale (DIDS)(Baseline, Month 3, Month 6, and Month 12)
- Cost-Utility Indicator: Quality-Adjusted Life Years (QALYs) Accumulated(12 months)
- Direct Healthcare Costs and Resource Consumption(12 months)