Assessment of a Non-Invasive System to Detect Changes in Physiological Tremor in Children and Adolescents with Type 1 Diabetes Mellitus.

Firefly Health Pty Ltd0 个研究点目标入组 20 人开始时间: 2016年10月25日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•*Have voluntarily given written informed consent to participate in the study.
•*Are male or female aged 5 years up to 18 years (inclusive).
•*Have type 1 diabetes (as determined by the Principal Investigator or delegate).
•*On no medication that may exacerbate or reduce the physiological tremor (as determined by the Principal Investigator or delegate).
•*Can wear both the CGMS and TIP3 Firefly Monitoring Device.
•*Participant is willing to perform at least 4 capillary blood glucose readings each day of study.
•*Participant and/or their caregiver/guardian is willing to keep the Diary as per protocol requirements.
•*Can follow the protocol for the CGM and the glucose meter.

•*Are unwilling to wear the clinical monitoring devices for the duration of the study
•*Any history of cerebro-vascular disease, central or peripheral neurological disease, idiopathic tremors, primary muscle disease, ischaemic muscle disease.
•*On medications that may affect muscle tremor.
•*Excessive use of alcohol (as determined by the Principal Investigator or his delegate).
•*Illicit drug use.
•*Dermatological conditions (e.g. psoriasis) involving the region of CGM insertion.
•*Current use of a CGM with alarms or plans to start using one during the study.
•*Unable to follow the protocols.

发起方

Firefly Health Pty Ltd