Please note that due to a high volume of submissions, the ANZCTR is currently experiencing a delay in processing of submissions.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
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
Scientific title
Assessment of a Non-Invasive System to Detect Changes in Physiological Tremor in Children and Adolescents with Type 1 Diabetes Mellitus.
Secondary ID [1] 290296 0
FFL-1488 (CM2715)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoglycaemia. 300538 0
Type 1 Diabetes 300674 0
Condition category
Condition code
Metabolic and Endocrine 300398 300398 0 0

Study type
Description of intervention(s) / exposure
Cross sectional, observational, non-randomised pilot study where all subjects wear the Firefly Monitoring Device (TIP3) overnight for 6 consecutive nights at home. The Firefly Monitoring Device is a noninvasive logging device designed to detect symptoms of hypoglycaemia utilising multiple sensors. It consists of a wrist band and parameters monitored include physiological tremor, temperature, and coarse limb movements.
With increasing hypoglycaemia the parameters monitored by the device are integrated and processed by a computational algorithm in this observational study.

Firefly is currently recruiting and conducting this study in Adelaide through CMAX (a division of IDT Australia Ltd). The study is being conducted over 7 days in children and teenagers, with the Friefly device worn overnight for 6 nights. The Firefly device is worn just prior to bedtime and worn overnight until the participant wakes up in the morning. When the Firefly device is not connected to the participant's wrist, it is connected to the tablet which has been given to the participant to charge the device and also upload data from the device, this also confirms the device was working properly on the previous night.

On Day 1, commencement of the study, a medical staff member undertakes the screening process to confirm eligibility and consent, demonstrates the instructions for use of the Firefly Device and also fits the participant with the continous glucose monitor (CGM) on the abdomen of the pariticipant. A diary is given to the parent/carer of the participant which is required to track daily activities, adherence of Firefly device being worn overnight and also timing of blood glucose level (BGL) readings per day. First BGL is taken 1 hour after the participant is fitted with the CGM and before the participant goes home to continue the study. At least 4 BGL readings are required per day before meals and bedtime for calibration of the CGM. The CGM is important in this study to assess the effectiveness of the Firefly device in monitoring signs of hypoglycaemia and to assist with the refinement of the algorithm within the device that generates the alerts. On Day 3 the parents/carers of the participants receive a call from a CMAX staff member to confirm adherence to the study protocol and ensure no difficulties with the devices, no adverse events and to provide any assistance if necessary. On Day 7, completion of the study, the CGM sensor is removed from a medical staff member and all diaries and devices are collected and data uploaded by the clinical staff member onto the study computer, A questionnaire is also handed by the clinical staff member to the parent/carer of the participant with regards to comfort and 'ease of use' of the Firefly device and any adverse events.
Intervention code [1] 296194 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group

Primary outcome [1] 299842 0
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.
Timepoint [1] 299842 0
7 days post wearing the device overnight.
Secondary outcome [1] 328284 0
A secondary objective is to evaluate patient acceptance regarding comfort and utility of the Firefly Monitoring device using a questionnaire designed for this study.
Timepoint [1] 328284 0
7 days post wearing the device overnight.

Key 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.
Minimum age
5 Years
Maximum age
18 Years
Both males and females
Can healthy volunteers participate?
Key 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
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
This is the first observational study in children and teenagers using the Firefly device.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 6788 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 14444 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 294674 0
Commercial sector/Industry
Name [1] 294674 0
Firefly Health Pty Ltd
Address [1] 294674 0
Level 1/10 Yarra Street, South Yarra, VIC 3141
Country [1] 294674 0
Primary sponsor type
Commercial sector/Industry
Firefly Health Pty Ltd
Level 1/10 Yarra Street, South Yarra, VIC 3141
Secondary sponsor category [1] 293525 0
Name [1] 293525 0
Address [1] 293525 0
Country [1] 293525 0

Ethics approval
Ethics application status
Ethics committee name [1] 296103 0
Women's and Children's Health Network, EC00197
Ethics committee address [1] 296103 0
Level 2, Samuel Way Building
72 King William Road
North Adelaide 5006 SA
Ethics committee country [1] 296103 0
Date submitted for ethics approval [1] 296103 0
Approval date [1] 296103 0
Ethics approval number [1] 296103 0

Brief summary
An observational, non-randomised pilot study in children and adolescents, 5 -18 years of age, with Type 1 Diabetes of a non-invasive device for monitoring signs of hypoglycaemia. The Firefly Monitoring Device, is a non-invasive wrist-band device which is worn overnight for 6 nights at home to monitor signs of hypoglycaemia such as physiological tremor using mutiple sensors. The Firefly Monitoring device is worn along with a continous glucose monitor (CGM) to assist in measuring glucose levels. The aim of this study is to refine the hypoglycaemia detection system of the Firefly Monitoring Devce in children and adolescents.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 69554 0
Dr Richard Burnet
Address 69554 0
Emeritus Physician, Women’s and Children’s Hospital and Honorary Endocrinologist, Royal Adelaide Hospital.
North Terrace, Adelaide SA 5000

Country 69554 0
Phone 69554 0
+61 (08) 7088 7900
Fax 69554 0
+61 (08) 7088 7999
Email 69554 0
Contact person for public queries
Name 69555 0
Ms Gabrielle Byars
Address 69555 0
Firefly Health Pty Ltd, Level 1/10 Yarra Street, South Yarra, VIC 3141
Country 69555 0
Phone 69555 0
+61 499 001 778
Fax 69555 0
Email 69555 0
Contact person for scientific queries
Name 69556 0
Ms Sheryl Harradine
Address 69556 0
CMAX, a division of IDT Australia Ltd
Level 5, 18a North Terrace
Adelaide SA 5000
Country 69556 0
Phone 69556 0
+61 8 7088 7940
Fax 69556 0
+61 (08) 7088 7999
Email 69556 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary