NCT05708040已完成不适用
Open-label, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Associated With a Continuous Glucose Monitoring System Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年8月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Time in Range
研究概览
简要总结
Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnostic criteria for DM1 according to ADA
- •Candidates for both systems (closed loop or smart insulin pen) for their usual healthcare team.
- •Acceptance of participation in the study and signing of the informed consent
排除标准
- •Gestation
- •Institutionalization, serious or terminal illness or renal replacement therapy.
- •Inability to undertake the training and / or acquire the degree of knowledge to use both systems
- •Refusal to participate in the study or to sign the informed consent
结局指标
主要结局
Time in Range
时间窗: 12 months
To assess the difference on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose).
次要结局
- A1c levels(12 months)
- Time above range(12 months)
- Health-Related Quality of Life in Patients with Type 1 Diabetes(12 months)
- Time below range(12 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect Of Vitalstim In Patients With Chronic Post-stroke Oropharyngeal DysphagiaDeglutition DisordersStrokeNCT02379182Pere Clave90
已完成
4 期
Study of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker---atherosclerosis Cerebral Infarction Patient as Study SubjectAtherosclerosis Cerebral InfarctionNCT00823875Otsuka Beijing Research Institute200
已完成
不适用
Study of Effect of Pecan Consumption on Caregiver Burden for Dementia PersoDementiaJPRN-UMIN000039229Matsubara-en, Medical Corporation Syoukyukai34
已完成
不适用
Efficacy and safety of intravaginal application of SAM vaginal gel on suspicious cervical smear results and on CIN 1 and CIN 2 lesionsCervical intraepithelial neoplasiaISRCTN11009040Deflamed International s.r.o.216
招募中
3 期
A clinical trial to compare the effect of Single Transition from Enbrel® Auto-Injector (AI) to YLB113 Auto-Injector in Patients with Active Rheumatoid Arthritis (RA).CTRI/2019/01/016851upin Limited Biotechnology Division