NCT06310980尚未招募不适用
Pilot Study in Order to Verify the Effect of the Use of a Smartpen Coordinated With a Continuous Glucose Sensor by a Dedicated App, in a Group of Adolescents in Not Good Control: Sensor Augmented Smartpen.
Giulio Frontino0 个研究点目标入组 34 人开始时间: 2024年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 主要终点
- Time in range
研究概览
简要总结
The Aim of this interventional study in to assess the effect of the use of a smartpen connected by an APP to continuous glucose sensors in a cohort of diabetic adolescents in not good metabolic control.
Primary endpoint: time in range Secondary endpoints: other glucometrics, Hba1c, treatment satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12 - 18 years
- •A clinical diagnosis of diabetes type 1 as determined by investigator for at least 12 months.
- •HbA1c >7.5% (DCA)
- •Subject is on multiple daily injection therapy (3 or more insulin injections per day one of which is a long acting insulin injection), is currently using or is willing to use insulin pens and pen cartridges and are not willing to use an insulin pump or AHCL system
- •Subject is currently using a CGM or is willing to use the Guardian 4 system during the study.
- •Subject and parents agree to comply with the study protocol requirements
- •Subject and parents provide their signature on the Informed Consent Form
排除标准
- •Subject is unwilling or unable to use insulin pen(s).
- •Subject is in plans to use or is already using an insulin pump.
- •Subject is currently using a non-Medtronic standalone CGM system and unwilling to use only the Guardian 4 system during the study.
- •Subject has any unresolved adverse skin condition in the area of device placement (e.g. psoriasis, rash, Staphylococcus infection).
- •Subject is actively participating in or plans to enroll in an investigational study (e.g. drug or device), other than this study, wherein they have received treatment from an investigational drug or device.
- •Subject has a positive urine pregnancy test at time of screening.
- •Subject is unwilling to participate in study procedures.
- •Subject is directly involved in the study as research staff.
- •Subject with poorly controlled thyroid or celiac disease.
- •Subject with any risk of exposure to MRI equipment, diathermy devices or other devices capable of generating strong magnetic fields
研究组 & 干预措施
smartpen
Experimental
patients treated by smartpen, glucose sensor and connected by a digital application
干预措施: smartpen (Device)
结局指标
主要结局
Time in range
时间窗: 3 months
Percentage of the time spent by 70-180 mg/dl
次要结局
- time above range(3 months)
- HbA1c(3 months)
- coefficient of variation (CV)(3 months)
- ITSRQ(end of the study)
- DIDS(3 months)
- time below range(3 months)
研究者
Giulio Frontino
sub investigator
IRCCS San Raffaele
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