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Trial registered on ANZCTR


Registration number
ACTRN12614000362695
Ethics application status
Approved
Date submitted
26/03/2014
Date registered
7/04/2014
Date last updated
7/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of a non-invasive system to detect changes in physiological tremor in type 1 diabetes mellitus
Scientific title
Assessment of a non-invasive system to detect changes in physiological tremor in type 1 diabetes mellitus
Secondary ID [1] 284338 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypoglycaemia in type 1 diabetics 291492 0
Condition category
Condition code
Metabolic and Endocrine 291859 291859 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 289059 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291771 0
Assessing changes in physiological tremor and identifying the level of blood glucose at which these changes occur.

The non invasive monitor utilises various transducers to monitor movement (accelerometer and gyroscope), and force (piezoelectric sensor). The monitor is to be connected to a real time data acquisition system and the data stored for later analysis.
Timepoint [1] 291771 0
To be continuously monitored from prior to the induction of hypoglycaemia, during hypoglycaemia and 40 minutes post hypoglycaemia.
Secondary outcome [1] 307505 0
Identifying other physiological changes that occur with hypoglycaemia.

The non invasive monitor utilises various transducers to monitor temperature (two skin surface temperature transducers to be attached with medical tape to a finger and wrist) and blood flow (pulse oximetry transducer to be mounted on a finger using a light clamp). The monitor is to be connected to a real time data acquisition system and the data stored for later analysis.

Blood sampling for serum glucose and neurotransmitters.

Continuous cardiac monitoring.

Time point monitoring of blood pressure, radial pulse rate, pulse oximetry and respiratory rate.
Timepoint [1] 307505 0
Non invasive monitor to continuously monitor from prior to the induction of hypoglycaemia, during hypoglycaemia and 40 minutes post hypoglycaemia.

Blood sampling and other time point monitoring to be from baseline and then, depending upon blood glucose levels, 5 minutely or 10 minutely from induction of hypoglycaemia until 40 minutes post reversal of hypoglycaemia.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study is an initial assessment of the effectiveness of a hypoglycaemic non invasive detector using changes in the physiological tremor. Under standardised conditions 100% responsiveness in showing changes in the amplitude of the physiological tremor is required. From earlier studies in diabetics there was a mean increase in amplitude in the physiological tremor of 300% in the elevated arm and a 100% mean increase in the resting arm.

An increase of power of greater than 20% is considered significant to allow the detectors to record a change. From confidence intervals tables a 95% level of confidence for this study, 6 participants were assessed as providing suitable data for analysis of the response of the detectors.

As the study design is recording serial measurements over time, analysis of variance and correlation will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2014
Actual
Date of last participant enrolment
Anticipated
30/04/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2247 0
The Royal Adelaide Hospital - Adelaide

Funding & Sponsors
Funding source category [1] 288975 0
Commercial sector/Industry
Name [1] 288975 0
Firefly Health Pty Ltd
Country [1] 288975 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Firefly Health Pty Ltd
Address
C/- 85 Carabooda Road
Carabooda 6033
Western Australia
Country
Australia
Secondary sponsor category [1] 287656 0
None
Name [1] 287656 0
Address [1] 287656 0
Country [1] 287656 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290788 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 290788 0
Ethics committee country [1] 290788 0
Australia
Date submitted for ethics approval [1] 290788 0
05/02/2014
Approval date [1] 290788 0
03/03/2014
Ethics approval number [1] 290788 0
2014-01-049

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

Contacts
Principal investigator
Name 47254 0
Dr Richard Burnet
Address 47254 0
CMAX (A division of IDT Australia Limited)
Level 5, East Wing
Royal Adelaide Hospital
North Terrace
ADELAIDE SA 5000
Country 47254 0
Australia
Phone 47254 0
+61 439 108 414
Fax 47254 0
Email 47254 0
[email protected]
Contact person for public queries
Name 47255 0
Elaine Darby
Address 47255 0
Firefly Health Pty Ltd
85 Carabooda Road
Carabooda 6033
Western Australia
Country 47255 0
Australia
Phone 47255 0
+61 458 372 511
Fax 47255 0
Email 47255 0
[email protected]
Contact person for scientific queries
Name 47256 0
Elaine Darby
Address 47256 0
Firefly Health Pty Ltd
85 Carabooda Road
Carabooda 6033
Western Australia
Country 47256 0
Australia
Phone 47256 0
+61 458 372 511
Fax 47256 0
Email 47256 0
[email protected]

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

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