None listed
Conditions
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.
Interventions
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 integ
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.
Sponsors
Firefly Health Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Healthy volunteers
No
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.
Outcome results
None listed