Study to Assist with Development of a Non-Invasive 'Wearable' Device to Measure Signs of Hypoglycaemia (Low Blood Sugar) in Children and Teenages with Type 1 Diabetes

Not Applicable

Completed

• Conditions: Hypoglycaemia.; Type 1 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616001482459
• Lead Sponsor: Firefly Health Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to obtain overnight exploratory data using the Firefly Monitoring device to determine the relationship of defined parameters (tremor and temperature) with hypoglycaemia using glucose levels as measured by a continuous glucose monitor (CGM) in a real-world” setting in children and adolescents (5-18 years inclusive) with type 1 diabetes. This will assist with the refinement of a hypoglycaemia detection monitoring system.[7 days post wearing the device overnight.]

Secondary Outcome Measures

Name	Time	Method
A secondary objective is to evaluate patient acceptance regarding comfort and utility of the Firefly Monitoring device using a questionnaire designed for this study.[7 days post wearing the device overnight.]