Randomized Clinical Trial to Assess the Efficacy of the System Insulclock® 360 for Insulin Treatment Management in Type 1 Diabetes Patients With Insufficient Glycemic Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Change in "Time In Range" (TIR)
研究概览
简要总结
Insulclock® is a small electronic device developed to facilitate the optimal administration of insulin. This device works as an add-on module of commercially available insulin pens and monitors the date, time and dose of injections, the type of insulin injected, the duration of injections and insulin temperature. The Insulclock 360 app allows automatic data logging, report generation and reminder setting, among other functions. In this study, we pretend to show the clinical impact of Insulclock system, both device and mobile application, on glycemic indices, treatment compliance, and quality of life in patients with persistent poorly controlled T1DM.
Material and methods: Randomized open-label multicenter controlled trial to evaluate glycemic control, the number of missed and delayed insulin doses, and quality of life after seven weeks of Insulclock 360 use in participants with uncontrolled DM1. We will also compare these results between patients with or without receiving system reminders and alerts.
This study aims to assess the effect of Insulclock on glycemic control, treatment adherence, and quality of life. As a secondary objective, we will compare the study outcomes between participants in the Active and Masked Insulclock groups (i.e., with or without receiving alerts and reminders and accessing the app).
To assess glycemic control, we will measure HbA1C and glycemic indices. Glycemic variability indices will be monitored with the FreeStyle Libre™ and included glucose coefficient of variation (CV), standard deviation (SD), time in range (TIR), time above range (TAR), and time below range (TBR). Mean glucose levels will be obtained from 48-h time intervals with the FreeStyle Libre.
A late meal bolus (mistimed) will be considered when Insulclock detects the injection at least 30 minutes after the CGM rise. To identify meal glucose excursions, we will use the Glucose Rate Increase Detector (GRID) algorithm, which estimates the rate of change (ROC) of glucose from CGM data.
Participants will complete the ITSQ and the DTSQ, which are validated questionnaires to assess the diabetes treatment satisfaction.
详细描述
Study design:
This multicentric randomized open-label study will be conducted at the Hospital General de Segovia (Segovia, Spain), Hospital de Cruces (Bilbao, Spain), Hospital Arquitecto Marcide (Ferrol, A Coruña, Spain) and Hospital Central de Asturias (Oviedo, Spain) after classification by the Spanish Agency for Medicines and Health Products (AEMPS) and ethical approval by the Ethics Review Committee of each research center. The study will be conducted in compliance with the ethical principles of the Declaration of Helsinki. Each participant will provide written informed consent before being included in the study.
The study is scheduled across seven visits. At Visit 1 (Screening, Week -1), demographic and clinical information will be collected, and concomitant medications will be registered. All potential study patients will be screened for eligibility after signing the informed consent form (ICF) and will be assigned with a patient identification number. Laboratory evaluations (HbA1c, serum chemistry) must be available within the last 2 months. An identification number will be assigned to each participant At Visit 2 (Run-in, week 0), participants will receive information on the use of the Insulclock device and app on masked mode (excluding the use of Insulclock 360 app information and alarms). If the participant does not use a CGM: a healthcare professional applies the FreeStyle Libre sensor to the back of the upper arm and activates it. If the participant already uses a CGM system, the patient will be encouraged to use sensors during this period.
At Visit 3 (First Visit CGM 1, week 1) and Visit 4 (Follow-up, week 3), participants will be encouraged to use the system At Visit 5 (Visit Starting CGM 2 and Randomization, week 4) participants will be randomized (1:1) to the Active Insulclock group or the Masked Insulclock group. Participants randomized in the Insulclock Active Group will receive detailed instructions on using the Insulclock device and Insulclock 360 mobile application and will be instructed and motivated for full use of all system functions (alarms, messages to the caregivers and investigation team). Participants randomized in the Insulclock Masked Group will be instructed on the correct installation and use of the Insulclock system for recording insulin bolus information but they will not receive any other information and will not have access to the Insulclock 360 application from the Internet and will keep administering insulin treatment as before. A healthcare professional will apply a FreeStyle Libre sensor to the upper arm in all the participants who do not use a CGM and will be encouraged to wear the sensor for 2 weeks. Participants who already use a CGM system will be encouraged to use sensors during this period.
At Visit 6 (Final Visit CGM 2 and Randomization, week 6). Participants will receive a reminder on the use of Insulclock according to the corresponding group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
- Patients will be instructed on the correct installation and use of the Insulclock 360 system for recording insulin bolus information.
- Patients do not receive any other information and will not have access to the Insulclock 360 application from the Internet.
- They will keep administering insulin treatment as before.
- Randomization is blind to the recruiting investigator.
入排标准
- 年龄范围
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age range: 14 to 80 years
- •DM1 diagnosed
- •Patients with type 1 diabetes and poor glycemic control, defined as:
- •HbA1c ≥ 6.5% during more than a year
- •and/or extreme variations (more than 1% of change in HbA1c in the last 2 years)
- •and regular visits to the Endocrinology Unit / Diabetes Unit (more than four each year).
- •Signed informed consent form
- •Ability of the subjects to use the system and fill the included questionnaires
- •Ability and willingness of following and be compatible with the protocol of the clinical trial
排除标准
- •Rejection or inability to give the informed consent to participate in the trial.
- •Pregnancy or lactation
- •Addiction or abuse of alcohol, or history of drug abuse in the last years
- •Dementia diagnosis
- •Acute infection
- •Any illness or condition that, according to investigator, could interfere with the trial
结局指标
主要结局
Change in "Time In Range" (TIR)
时间窗: Baseline, 7 weeks
TIR, is the percentage of time that a person spends with their blood glucose levels in a target range. The range will vary depending on the person, but general guidelines suggest starting with a range of 70 to 180 mg/dl. Glucose levels are obtained from Continuous Glucose Monitor (CGM) and investigators compare the results obtained within the first 4 weeks of the study with the values of the next 3 weeks of the study.
Number of daily insulin injections irregularities
时间窗: Week 0 through week 7
The number of insulin injections irregularities (omission, mistiming and dosing) will be registered in the Insulclock pen cap device and will be transferred to the Insulclock mobile application in real time to monitor treatment adherence.The moment of the insulin injection will be compared with the moment of food intake analyzing the glycemic excursion. Investigators will determine if the insulin was injected with ahead of time enough, so that catalog the injection as on time, mistiming or omission.
次要结局
- Change in Mean glucose(Baseline, 7 weeks)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQc-change) Score.(Baseline, 7 weeks)
- Change in Insulin Treatment Satisfaction Questionnaire (ITSQ-change) Score.(Baseline, 7 weeks)