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Trial registered on ANZCTR
Registration number
ACTRN12615000327583
Ethics application status
Approved
Date submitted
23/03/2015
Date registered
9/04/2015
Date last updated
6/06/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
An exploratory study evaluating the measurement of non-glycaemic parameters as markers of impending or present hypoglycaemia in people with Type 1 Diabetes.
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Scientific title
An exploratory study evaluating the measurement of non-glycaemic parameters as markers of impending or present hypoglycaemia in people with Type 1 Diabetes.
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Secondary ID [1]
286186
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Nil
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Universal Trial Number (UTN)
U1111-1167-2794
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes
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Condition category
Condition code
Metabolic and Endocrine
294533
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study aims to obtain overnight exploratory data regarding the relationship of non-glycaemic parameters (such as wrist and finger tremor and temperature to hypoglycaemia) in Type 1 Diabetes participants. This study intends to evaluate the accuracy of a non-invasive device designed to detect these early signs of hypoglycaemia.
The Investigational Device (ID) consists of a wrist band connected by a flexible wire to a ring. Participants will wear the ID overnight placed on the wrist and middle finger of the non-dominant hand prior to retiring to bed. The ID will be removed after the participant wakes in the morning. Parameters including wrist and finger tremor and temperature will be monitored continuously by the ID during wear.
Following baseline assessment, participants will be provided with education regarding the ID. Participants will be instructed to undertake reference capillary blood glucose measurements (a minimum of 4 times a day over the 2 week study period) and to wear Continuous Glucose Monitoring (CGM) sensors for the two-week study duration.
During the study, the participants will also be instructed to keep a diary documenting activity, diet, capillary glucose reading, insulin, and hypogylcaemic episodes.
Participants will attend the Clinical Trials Centre (CTC) on Day 8 to have the CGM sensor changed. On Day 15, participants will attend the CTC for collection of the study devices and diary.
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Intervention code [1]
291199
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Treatment: Devices
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Comparator / control treatment
No Control
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Correlation of tremor at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds.
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Assessment method [1]
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Timepoint [1]
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Monitored every 5 minutes overnight over the 2 week study period.
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Primary outcome [2]
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Correlation of temperature at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds.
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Assessment method [2]
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Timepoint [2]
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Monitored every 5 minutes overnight over the 2 week study period.
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Secondary outcome [1]
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Correlation of tremor at wrist and finger measured by the ID with CGM rate of change in glucose.
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Assessment method [1]
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Timepoint [1]
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Monitored every 5 minutes overnight over the 2 week study period.
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Secondary outcome [2]
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Correlation of temperature at wrist and finger measured by the ID with CGM rate of change in glucose.
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Assessment method [2]
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Timepoint [2]
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Monitored every 5 minutes overnight over the 2 week study period.
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Secondary outcome [3]
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Correlation of difference in temperature at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds.
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Assessment method [3]
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Timepoint [3]
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Monitored every 5 minutes overnight over the 2 week study period.
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Secondary outcome [4]
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Correlation of difference in temperature at wrist and finger measured by the ID with CGM rate of change in glucose.
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Assessment method [4]
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Timepoint [4]
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Monitored every 5 minutes overnight over the 2 week study period.
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Secondary outcome [5]
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A comparison of the parameters (tremor, temperature) and rate of change in these parameters measured by the ID with confirmatory finger-prick blood-glucose meter readings above and below hypoglycaemia thresholds.
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Assessment method [5]
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Timepoint [5]
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Done during symptoms of hypoglycaemia over the 2 week study period.
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Secondary outcome [6]
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Differences and similarities noted in the above associations described above comparing hypoglycaemia aware vs. hypoglycaemia unaware participants, as per Gold Score for hypogylcaemia unawareness.
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Assessment method [6]
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Timepoint [6]
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Monitored every 5 minutes overnight over the 2 week study period.
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Secondary outcome [7]
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Participant acceptance regarding comfort and utility of the device.
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Assessment method [7]
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Timepoint [7]
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Assessed via an interview on Day 15.
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Eligibility
Key inclusion criteria
-Type 1 Diabetes
-HbA1c <9.0%
-Participant willing to comply with study protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
-Diabetic ketoacidosis within the past 4 weeks
-Pregnant or planned pregnancy during the study period
-Dermatological conditions involving the region of glucose sensor insertion
-Participant on beta-blocker therapy
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive statistics will be used to define correlations between the study parameters. As this is an exploratory hypothesis generating study, statistical power has not been calculated but the results will be used to inform larger studies incorporating clinical interventions.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
13/04/2015
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Actual
13/04/2015
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Date of last participant enrolment
Anticipated
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Actual
27/09/2016
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Date of last data collection
Anticipated
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Actual
11/10/2016
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Sample size
Target
80
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Firefly Health Pty Ltd
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Address [1]
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255 Mary Street
Richmond 3121 VIC
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
St Vincents Hospital Melbourne
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Address
41 Victoria Parade
Fitzroy 3065 VIC.
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Country
Australia
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Secondary sponsor category [1]
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Other
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Name [1]
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Baker IDI Heart and Diabetes Institute
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Address [1]
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75 Commercial Road
Melbourne 3004
VIC.
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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St Vincent's Hospital Melbourne
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Ethics committee address [1]
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Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
292430
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Approval date [1]
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19/02/2015
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Ethics approval number [1]
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HREC-D 006/15
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Summary
Brief summary
Insulin therapy for people with Type 1 Diabetes has the risk of hypoglycaemia when insulin administration is in excess of their requirements. This hypoglycaemia is a major contributor in the failure to achieve glycaemic targets in Type 1 Diabetes.
The Investigational Device is a non-invasive device designed to detect warning signs of hypoglycaemia. The device consists of a wrist band connected by a flexible wire to a ring. Parameters monitored by this device include wrist and finger tremor and temperature.
The study aims to collect overnight exploratory data regarding the relationship of the above parameters to hypoglycaemia. Having a device that has the potential to provide an early warning of impending hypoglycaemia may have a positive impact upon the wellbeing of the person with Type 1 Diabetes.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof David O'Neal
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Address
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St Vincent's Hospital
41 Victoria Parade
Fitzroy
Victoria 3065
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Country
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Australia
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Phone
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+61 3 92312211
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Sybil McAuley
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Address
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Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
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Country
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Australia
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Phone
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+61 3 9231 2211
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Sybil McAuley
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Address
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Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
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Country
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Australia
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Phone
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+61 3 9231 2211
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Fax
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Email
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[email protected]
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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
No additional documents have been identified.
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