None listed
Conditions
Brief summary
Insulin therapy for people with type 1 diabetes has a risk of hypoglycaemia when insulin delivered is in excess of the individual's requirements. Hypoglycaemia is a major contributor to the failure to achieve glycaemic targets in type 1 diabetes. The device under investigation is a non-invasive wearable device designed to detect hypoglycaemia. The device consists of a wrist band connected by a flexible wire to a ring. Parameters monitored by the device include microtremor and temperature. This study aims to investigate the performance of the device to alert the wearer to the presence of hypoglycaemia overnight. A non-invasive wearable device able to alert for hypoglycaemia may improve the health and well-being of people with type 1 diabetes.
Interventions
This study aims to investigate the performance of a non-invasive wearable device to alert for nocturnal hypoglycaemia.
The investigational device (ID) is a non-invasive device designed to detect hypoglycaemia. It consists of a wrist band connected by a flexible wire to a ring. Parameters including wrist and finger microtremor, skin temperature and coarse limb movements are monitored continuously by the ID during wear. The ID data is processed by an artificial neural network. When pre-determined
This study aims to investigate the performance of a non-invasive wearable device to alert for nocturnal hypoglycaemia. The investigational device (ID) is a non-invasive device designed to detect hypoglycaemia. It consists of a wrist band connected by a flexible wire to a ring. Parameters including wrist and finger microtremor, skin temperature and coarse limb movements are monitored continuously by the ID during wear. The ID data is processed by an artificial neural network. When pre-determined criteria are met signifying that the likelihood of hypoglycaemia has exceeded a specified threshold, an alarm sounds to alert the wearer. Participants will wear the ID overnight each night for 5 weeks, Prior to retiring to bed, the ID is placed on the wrist and middle finger of the non-dominant hand. The ID is removed after waking in the morning. Following ID removal, the data will be offloaded for processing. Following baseline assessment, participants will be provided with education regarding the ID (a verbal 10 min description provided by a study nurse), and instructed to wear the device each night during the study. There is a one week run-in period when the device alert capability is not activated. After run-in, participants return to the trial centre for insertion of a continuous glucose monitoring (CGM) sensor. A CGM system, glucose meter (for capillary blood glucose measurement) and study log book will be provided, together with education about their use provided by a study nurse. Participants will be instructed to measure their blood glucose at least 4 times/day for CGM calibration. During nocturnal ID wear, if the ID alerts or if symptoms of hypoglycaemia are experienced, the participant is instructed to check their blood glucose via the glucose meter. Usual insulin regimen, diet and daily activities are to be maintained. Participants will subsequently return to the trial centre weekly during the study for review and for replacement of their glucose sensor. Participants will have a total of 4 weeks of CGM. At study conclusion, an interview about usage of the ID will be conducted, and all study devices and log books will be returned.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Type 1 diabetes HbA1c <9.5% Willing and able to comply with study protocol Able to refrain from paracetamol use during study
Exclusion criteria
Diabetic ketoacidosis within the past 4 weeks Pregnancy Dermatological condition involving the region of glucose sensor insertion or ID fitment Beta-blocker therapy Tremor disorder Hearing impairment limiting ability to hear ID alarm
Outcome results
None listed