ACTRN12616001482459
Completed
未知
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 sites20 target enrollmentOctober 25, 2016
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Hypoglycaemia.
- Sponsor
- Firefly Health Pty Ltd
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*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.
Exclusion Criteria
- •\*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.
Outcomes
Primary Outcomes
Not specified
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