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Trial registered on ANZCTR


Registration number
ACTRN12617000814370
Ethics application status
Approved
Date submitted
29/03/2017
Date registered
5/06/2017
Date last updated
8/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
An investigation of a non-invasive device to alert people with type 1 diabetes to the presence of nocturnal hypoglycaemia
Scientific title
An investigation of the performance a non-invasive device measuring microtremor and temperature to alert people with type 1 diabetes to the presence of nocturnal hypoglycaemia
Secondary ID [1] 291558 0
None
Universal Trial Number (UTN)
U1111-1194-7991
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 302653 0
Condition category
Condition code
Metabolic and Endocrine 302169 302169 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297622 0
Treatment: Devices
Comparator / control treatment
CGM for 4 weeks
Control group
Active

Outcomes
Primary outcome [1] 301595 0
Proportion of ID alerts associated with capillary blood glucose <4.0 mmol/L
Timepoint [1] 301595 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [1] 333242 0
Proportion of ID alerts associated with capillary blood glucose <4.5 mmol/L
Timepoint [1] 333242 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [2] 333245 0
Proportion of ID alerts associated with capillary blood glucose <3.5 mmol/L
Timepoint [2] 333245 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [3] 333246 0
Proportion of ID alerts associated with capillary blood glucose <3.0 mmol/L
Timepoint [3] 333246 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [4] 333247 0
Proportion of ID alerts associated with capillary blood glucose <2.5 mmol/L
Timepoint [4] 333247 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [5] 333248 0
Proportion of ID alerts associated with capillary blood glucose >=4.5 mmol/L
Timepoint [5] 333248 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [6] 333249 0
Proportion of ID alerts associated with capillary blood glucose >=4.0 mmol/L
Timepoint [6] 333249 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [7] 333250 0
Proportion of times the ID did not alert when capillary blood glucose was >=4.5 mmol/L
Timepoint [7] 333250 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [8] 333251 0
Proportion of times the ID did not alert when capillary blood glucose was >=4.0 mmol/L
Timepoint [8] 333251 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [9] 333252 0
Proportion of times the ID did not alert when capillary blood glucose was >=3.5 mmol/L
Timepoint [9] 333252 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [10] 333253 0
Proportion of times the ID did not alert when capillary blood glucose was >=3.0 mmol/L
Timepoint [10] 333253 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [11] 333254 0
Proportion of times the ID did not alert when capillary blood glucose was >=2.5 mmol/L
Timepoint [11] 333254 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [12] 333255 0
Proportion of ID alerts, occurring at each of the glucose thresholds listed above in the primary outcome and secondary outcomes #1-6, lasting at least 20 min on CGM
Timepoint [12] 333255 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [13] 333256 0
Proportion of ID alerts associated with CGM glucose >=4.5 mmol/L for at least 10 min before and after alert
Timepoint [13] 333256 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [14] 333257 0
Proportion of ID alerts associated with CGM glucose >=4.0 mmol/L for at least 10 min before and after alert
Timepoint [14] 333257 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [15] 333258 0
Proportion of episodes with CGM glucose <4.5 mmol/L for at least 20 min when the ID did not alert
Timepoint [15] 333258 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [16] 333259 0
Proportion of episodes with CGM glucose <4.0 mmol/L for at least 20 min when the ID did not alert
Timepoint [16] 333259 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [17] 333260 0
Proportion of episodes with CGM glucose <3.5 mmol/L for at least 20 min when the ID did not alert
Timepoint [17] 333260 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [18] 333261 0
Proportion of episodes with CGM glucose <3.0 mmol/L for at least 20 min when the ID did not alert
Timepoint [18] 333261 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [19] 333262 0
Proportion of episodes with CGM glucose <2.5 mmol/L for at least 20 min when the ID did not alert
Timepoint [19] 333262 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [20] 333263 0
Proportion of ID alerts associated with severe hypoglycaemia
Timepoint [20] 333263 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [21] 333264 0
Number of subsequent ID alerts during nights where the ID has already alerted that night.
Timepoint [21] 333264 0
During nocturnal ID wear in the final 4 weeks of the study
Secondary outcome [22] 333265 0
Acceptability of the ID, assessed by semi-structured interview
Timepoint [22] 333265 0
5 weeks post-commencement of ID wear, at the end-of-study visit

Eligibility
Key inclusion criteria
Type 1 diabetes
HbA1c <9.5%
Willing and able to comply with study protocol
Able to refrain from paracetamol use during study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
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
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Exploratory analyses will be undertaken. These will include descriptive statistics, and determination of the sensitivity and specificity of the ID to alert for nocturnal hypoglycaemia.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/06/2017
Actual
7/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7736 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 7746 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 15661 0
3065 - Fitzroy
Recruitment postcode(s) [2] 15675 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 296048 0
Commercial sector/Industry
Name [1] 296048 0
Firefly Health Pty Ltd
Country [1] 296048 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Pde
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 294959 0
None
Name [1] 294959 0
Address [1] 294959 0
Country [1] 294959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297304 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 297304 0
Ethics committee country [1] 297304 0
Australia
Date submitted for ethics approval [1] 297304 0
Approval date [1] 297304 0
16/03/2017
Ethics approval number [1] 297304 0
HREC 016/17

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

Contacts
Principal investigator
Name 73646 0
A/Prof David O'Neal
Address 73646 0
St Vincent's Hospital Melbourne
35 Victoria Pde Fitzroy VIC 3065
Country 73646 0
Australia
Phone 73646 0
+61 3 9231 2211
Fax 73646 0
Email 73646 0
dno@unimelb.edu.au
Contact person for public queries
Name 73647 0
Hannah Jones
Address 73647 0
St Vincent's Hospital Melbourne
35 Victoria Pde Fitzroy VIC 3065
Country 73647 0
Australia
Phone 73647 0
+61 3 9231 2211
Fax 73647 0
Email 73647 0
hannah.jones@svha.org.au
Contact person for scientific queries
Name 73648 0
Sybil McAuley
Address 73648 0
St Vincent's Hospital Melbourne
35 Victoria Pde Fitzroy VIC 3065
Country 73648 0
Australia
Phone 73648 0
+61 3 9231 2211
Fax 73648 0
Email 73648 0
sybil.mcauley@svha.org.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
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