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Trial registered on ANZCTR


Registration number
ACTRN12616001482459
Ethics application status
Approved
Date submitted
20/10/2016
Date registered
25/10/2016
Date last updated
17/10/2017
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
Diabetes

Intervention/exposure
Study type
Interventional
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
Uncontrolled

Outcomes
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.

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Diagnosis
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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is the first observational study in children and teenagers using the Firefly device.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/10/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
2/03/2017
Date of last data collection
Anticipated
10/08/2017
Actual
28/03/2017
Sample size
Target
20
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
SA
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
Country [1] 294674 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Firefly Health Pty Ltd
Address
Level 1/10 Yarra Street, South Yarra, VIC 3141
Country
Australia
Secondary sponsor category [1] 293525 0
None
Name [1] 293525 0
Address [1] 293525 0
Country [1] 293525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296103 0
Women's and Children's Health Network, EC00197
Ethics committee address [1] 296103 0
Ethics committee country [1] 296103 0
Australia
Date submitted for ethics approval [1] 296103 0
13/11/2015
Approval date [1] 296103 0
22/04/2016
Ethics approval number [1] 296103 0
HREC/15/WCHN/186

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 69554 0
+61 (08) 7088 7900
Fax 69554 0
+61 (08) 7088 7999
Email 69554 0
hair77@bigpond.com
Contact person for public queries
Name 69555 0
Gabrielle Byars
Address 69555 0
Firefly Health Pty Ltd, Level 1/10 Yarra Street, South Yarra, VIC 3141
Country 69555 0
Australia
Phone 69555 0
+61 499 001 778
Fax 69555 0
Email 69555 0
gabrielle.byars@fireflyhealth.com.au
Contact person for scientific queries
Name 69556 0
Sheryl Harradine
Address 69556 0
CMAX, a division of IDT Australia Ltd
Level 5, 18a North Terrace
Adelaide SA 5000
Country 69556 0
Australia
Phone 69556 0
+61 8 7088 7940
Fax 69556 0
+61 (08) 7088 7999
Email 69556 0
sheryl.harradine@cmax.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.