Transition to Hospital Discharge in Insulinized Patients With Type 2 Diabetes Mellitus and Incorporation Into a Comprehensive Diabetes Management System
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
- 1
- 主要终点
- Therapeutic adherence
研究概览
简要总结
This clinical study explores whether adding technological tools during hospital discharge can help people with type 2 diabetes who are starting insulin therapy achieve better treatment adherence and blood glucose control once they return home. The discharge transition period includes both the final days of hospitalization and the first weeks to months after returning home.
When people with type 2 diabetes are hospitalized, they sometimes need to begin insulin therapy. After discharge, managing insulin properly is essential to avoid high or low blood sugar levels. However, many patients forget or delay insulin doses, which can lead to poor control of their diabetes.
This study will compare two groups of patients. All participants will be adults with type 2 diabetes, between 18 and 70 years old, who are newly starting insulin during their hospital stay.
Group 1 ("technological group") will use a continuous glucose monitor (CGM) and a smart insulin pen cap called Insulclock. These tools show real-time blood glucose data and record when and how much insulin is injected. Patients and doctors can use this information to better adjust treatment. Insulclock also includes alarms to remind patients of their doses.
Group 2 ("control group") will use the same devices, but they will not see the data in real time. Instead, they will manage their insulin based on standard finger-prick blood sugar checks four times a day, as typically done in standard care.
Both groups will be followed for 12 weeks after hospital discharge. Medical check-ins will occur in weeks 1, 2, 4, 8, and 12. Blood tests and treatment adjustments will be performed as needed.
The main goals are:
To measure if the use of technology helps patients stick to their insulin schedule (fewer missed or mistimed injections).
To see if it leads to better blood glucose control (e.g., more time within the recommended range, fewer episodes of low or high glucose).
To evaluate patient satisfaction with this technology and check if the number of unplanned hospital readmissions decreases.
The study will take place at Hospital Universitari i Politècnic La Fe in Valencia, Spain. Around 80 patients will participate.
This study is important because real-world data about the use of CGM and smart insulin devices during the hospital-to-home transition are limited. It may help improve diabetes care for people starting insulin after hospitalization.
详细描述
The transition from hospital to home is a clinically vulnerable phase for patients with type 2 diabetes mellitus (T2DM), particularly for those who are newly initiated on insulin therapy during hospitalization. This period is characterized by increased therapeutic complexity, limited patient confidence with insulin use, and heightened risk of poor glycemic outcomes. Suboptimal adherence to insulin regimens-including missed or delayed doses-is common and has been associated with adverse clinical events, reduced quality of life, and higher healthcare utilization, including unplanned readmissions.
While continuous glucose monitoring (CGM) systems and smart insulin pen caps have individually shown promise in improving glycemic control and treatment adherence, there is a lack of robust data regarding their effectiveness when introduced in the peri-discharge period. Importantly, the transition from inpatient to outpatient care has been highlighted as a critical moment to implement structured, technology-supported interventions aimed at improving self-management and continuity of care.
This study investigates whether the combination of CGM and Insulclock® technology, initiated during hospitalization and continued after discharge, improves glycemic control and adherence in insulin-treated T2DM patients. Unlike prior studies, this trial evaluates these devices not only as monitoring tools but also as real-time decision-making supports during a period of high clinical risk.
In addition to assessing standard glycemic metrics - including time in range (TIR), time below and above range (TBR, TAR), coefficient of variation, and HbA1c - the study will measure patient-reported treatment satisfaction and unplanned hospital readmissions within 30 days. The outcomes of this research may inform future protocols for diabetes discharge planning and support the integration of connected technologies into standard care pathways for insulin initiation in hospitalized patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years.
- •Hospitalized patients with a diagnosis of type 2 diabetes mellitus (T2DM), either newly diagnosed during admission or previously known but not previously treated with insulin.
- •Initiation of insulin therapy (basal, basal-plus, or basal-bolus regimen) during hospitalization, with planned continuation post-discharge.
- •Independent in basic activities of daily living.
- •Adequate cognitive and functional capacity to manage the required devices: insulin pen, glucometer, continuous glucose monitoring (CGM) sensor, and Insulclock® cap.
排除标准
- •Dependence in basic activities of daily living.
- •Any medical condition or functional limitation precluding the use of the CGM or the Insulclock® system.
- •Pregnancy or intention to become pregnant.
- •Diagnosis of type 1 diabetes mellitus.
- •Patients undergoing dialysis.
研究组 & 干预措施
Use of blind continuous glucose sensor and smart insulin pen cap.
From discharge, use of a blind continuous glucose sensor and a smart insulin pen cap. Insulin therapy decision-making based on capillary blood glucose.
干预措施: Usual Care group (Device)
Use of continuous glucose sensor and smart insulin pen cap and is able to see the parameters.
From discharge, a continuous glucose sensor and smart insulin pen cap are used, and the subject is able to see its parameters. Insulin therapy decision-making is based on the continuous glucose sensor and smart cap parameters.
干预措施: Technological group (Device)
结局指标
主要结局
Therapeutic adherence
时间窗: From baseline (hospital discharge) to 12 weeks post-discharge
Assessment of therapeutic adherence based on the number of injustified insulin administration omissions per week. Measured by Number of missed basal and bolus insulin doses within any 14-day period during follow-up. Method of Assessment: Data will be collected through the digital insulin pen smart cap system (Insulclock®), which automatically records each insulin administration and detects missed doses.
Time in Range
时间窗: From baseline (hospital discharge) to 12 weeks post-discharge
Percentage of time that interstitial glucose values remain within the target range of 70 to 180 mg/dL, as measured by continuous glucose monitoring (CGM). This metric reflects the effectiveness of glycemic control in patients with type 2 diabetes. TIR is widely recognized as a clinically meaningful outcome in diabetes technology studies. Unit of Measurement: Percentage (%) of time in target range Method of Assessment: data will be collected from continuous glucose monitoring systems (e.g., Dexcom G6 or equivalent), which record interstitial glucose every 5 minutes. TIR will be calculated over the monitoring period using standard CGM metrics, following international consensus guidelines. Justification: TIR has been endorsed as a key metric in diabetes management by the International Consensus on Time in Range. It correlates with reduced risk of microvascular complications and complements traditional measures such as HbA1c.
次要结局
- Health-related quality of life assessed using the EQ-5D-5L (EuroQol)(At 12 weeks post-discharge)
- Medication adherence assessed by the 4-item Morisky-Green test (MMAS-4)(At 12 weeks post-discharge)
- Time Below Range(From baseline (hospital discharge) to 12 weeks post-discharge)
- Time Above Range(From baseline (hospital discharge) to 12 weeks post-discharge)
- Coefficient of Variation(From baseline (hospital discharge) to 12 weeks post-discharge)
- Mean Glucose Level(From baseline (hospital discharge) to 12 weeks post-discharge)
- Glycated Hemoglobin (HbA1c)(At 12 weeks post-discharge)
- Re-hospitalization Rate(Within 30 days post-discharge)
- Number of off-schedule insulin administrations(From hospital discharge to 12 weeks post-discharge)
- Number of participants with abnormal laboratory tests results(During index hospitalization (baseline) and 12 weeks post-discharge)
- Use of corticosteroids during hospitalization(During hospitalization (baseline))
- Use of corticosteroids at discharge(At hospital discharge to 12 weeks post-discharge)
- Insulin dose intensity at discharge(Baseline)
- Insulin dose intensity 12 weeks post-discharge(12 weeks post-discharge)
- Length of hospital stay(During hospitalization)
- Use of oral antidiabetic drugs at discharge(at hospital discharge and at 12 weeks post-discharge)
- Body Weight(Baseline (hospitalization) and at 12 weeks post-discharge)
- Height(Baseline (hospitalization))
- Body Mass Index (BMI)(Baseline (hospitalization) and at 12 weeks post-discharge)
- Global cardiovascular risk category(Baseline (hospitalization))
研究者
Juan Francisco Merino Torres
Chief of Endocrinology, Professor of Medicine, and Principal Investigator
Instituto de Investigacion Sanitaria La Fe