None listed
Conditions
Brief summary
The objective of this study is to verify the effectiveness of a non invasive warning system in detecting hypoglycaemic (low blood sugar levels) episodes in type 1 diabetics.
Interventions
Changes in physiological tremor associated with hypoglycaemia being observed to assess the effectiveness of a non invasive monitor. Hypoglycaemia is to be induced in the participants for these changes to be observed.
Hypoglycaemia is to be induced by the administration of IV insulin until the blood glucose levels is less than or equal to 5mmol. Hypoglycaemia will be reversed with the administration of IV glucose when blood glucose levels are less than or equal to 2.4mmol or at the discretion
Changes in physiological tremor associated with hypoglycaemia being observed to assess the effectiveness of a non invasive monitor. Hypoglycaemia is to be induced in the participants for these changes to be observed. Hypoglycaemia is to be induced by the administration of IV insulin until the blood glucose levels is less than or equal to 5mmol. Hypoglycaemia will be reversed with the administration of IV glucose when blood glucose levels are less than or equal to 2.4mmol or at the discretion of the Principal Investigator. The non invasive monitor will be attached to the participant prior to the induction of insulin and will continually monitor changes in physiological tremor until 40 minutes post glucose administration. The non invasive monitor utilises multiple sensors which are connected to the participant's forearms, wrists and fingers as follows: The wrist worn unit is mounted on the participant's non dominant arm forearm close to the wrist using fabric wrist straps. The skin surface temperature transducers are adhered to one finger of the participant's dominant arm and the other on the wrist of the dominant arm using medical tape. The finger pulse oximeter is mounted on a finger of the dominant arm using a light clamp. The piezoelectric film sensor transducer is adhered to the participant's non dominant arm near the wrist using medical tape.
Sponsors
Firefly Health Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Have type 1 diabetes mellitus and are willing to have induced hypoglycaemia under medical supervision 2. Have adequate venous access to both arms to allow for IV administration of insulin and glucose and for the collection of blood samples 3. Have adequate surface area on the non dominate arm to allow for the application of all study related monitoring devices 4. Be willing to fast for up to 14 hours
Exclusion criteria
1. Are unwilling to wear the clinical monitoring devices for the duration of the study. 2. Have a history of cerebrovascular disease, central or peripheral neurological disease, idiopathic tremors, primary muscle disease, hypokalaemia or a concurrent illness that in the Principal Investigator's opinion would interfere with study procedures. 3. Have a history of, or current evidence of abuse of alcohol or any illicit drug substances. 4. Have a positive breath alcohol or urine drug screening on day 1. 5. Unable to abstain from alcohol during the 48 hours prior to day 1 and until completion of blood sampling on day 1. 6. Tobacco users who are unable to abstain from smoking whilst confined to the clinical facility 7. Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthenes (eg coffee, tea, cola and chocolate) during the 48 hours prior to day 1 and until completion of blood sampling on day 1. 8. Are pregnant or breast feeding. 9. Has been in receipt of an investigational agent within 4 weeks of screening. 10. Have given a standard blood donation within the 12 week period prior to day 1. 11. Are currently taking regular prescription or over the counter medications including vitamins and dietary supplements that may induce or mask muscle tremor. Including but not limited to muscle stimulants, muscle relaxants or medications with potential to cause muscle toxicity. 12. Have experienced a serious hypoglycaemic episode (requiring the assistance of another person) within the 2 weeks prior to day 1. 13. Have a BMI of equal to or greater than 40kg/m2 and weigh equal to or greater than 110kg. 14. Are unwilling to remove nail varnish or false nails for the duration of day 1. 15. Are currently using an insulin pump.
Outcome results
None listed