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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.
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.
Secondary ID [1] 286186 0
Nil
Universal Trial Number (UTN)
U1111-1167-2794
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 294215 0
Condition category
Condition code
Metabolic and Endocrine 294533 294533 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.




Intervention code [1] 291199 0
Treatment: Devices
Comparator / control treatment
No Control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294313 0
Correlation of tremor at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds.
Timepoint [1] 294313 0
Monitored every 5 minutes overnight over the 2 week study period.
Primary outcome [2] 294382 0
Correlation of temperature at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds.
Timepoint [2] 294382 0
Monitored every 5 minutes overnight over the 2 week study period.
Secondary outcome [1] 313010 0
Correlation of tremor at wrist and finger measured by the ID with CGM rate of change in glucose.
Timepoint [1] 313010 0
Monitored every 5 minutes overnight over the 2 week study period.
Secondary outcome [2] 313165 0
Correlation of temperature at wrist and finger measured by the ID with CGM rate of change in glucose.
Timepoint [2] 313165 0
Monitored every 5 minutes overnight over the 2 week study period.
Secondary outcome [3] 313166 0
Correlation of difference in temperature at wrist and finger measured by the ID with CGM glucose level above vs. below hypoglycaemia thresholds.
Timepoint [3] 313166 0
Monitored every 5 minutes overnight over the 2 week study period.
Secondary outcome [4] 313167 0
Correlation of difference in temperature at wrist and finger measured by the ID with CGM rate of change in glucose.
Timepoint [4] 313167 0
Monitored every 5 minutes overnight over the 2 week study period.
Secondary outcome [5] 313168 0
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.
Timepoint [5] 313168 0
Done during symptoms of hypoglycaemia over the 2 week study period.
Secondary outcome [6] 313169 0
Differences and similarities noted in the above associations described above comparing hypoglycaemia aware vs. hypoglycaemia unaware participants, as per Gold Score for hypogylcaemia unawareness.
Timepoint [6] 313169 0
Monitored every 5 minutes overnight over the 2 week study period.
Secondary outcome [7] 313170 0
Participant acceptance regarding comfort and utility of the device.
Timepoint [7] 313170 0
Assessed via an interview on Day 15.

Eligibility
Key inclusion criteria
-Type 1 Diabetes
-HbA1c <9.0%
-Participant willing to comply with study protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3504 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 9269 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 290804 0
Commercial sector/Industry
Name [1] 290804 0
Firefly Health Pty Ltd
Address [1] 290804 0
255 Mary Street

Richmond 3121 VIC

Country [1] 290804 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital Melbourne
Address
41 Victoria Parade
Fitzroy 3065 VIC.
Country
Australia
Secondary sponsor category [1] 289491 0
Other
Name [1] 289491 0
Baker IDI Heart and Diabetes Institute
Address [1] 289491 0
75 Commercial Road
Melbourne 3004
VIC.
Country [1] 289491 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292430 0
St Vincent's Hospital Melbourne
Ethics committee address [1] 292430 0
Research Governance Unit
Level 5, Mary Aikenhead Building
27 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 292430 0
Australia
Date submitted for ethics approval [1] 292430 0
Approval date [1] 292430 0
19/02/2015
Ethics approval number [1] 292430 0
HREC-D 006/15

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54974 0
A/Prof David O'Neal
Address 54974 0
St Vincent's Hospital
41 Victoria Parade
Fitzroy
Victoria 3065
Country 54974 0
Australia
Phone 54974 0
+61 3 92312211
Fax 54974 0
Email 54974 0
dno@unimelb.edu.au
Contact person for public queries
Name 54975 0
Dr Sybil McAuley
Address 54975 0
Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 54975 0
Australia
Phone 54975 0
+61 3 9231 2211
Fax 54975 0
Email 54975 0
sybil.mcauley@svha.org.au
Contact person for scientific queries
Name 54976 0
Dr Sybil McAuley
Address 54976 0
Department of Endocrinology & Diabetes, St Vincent's Hospital Melbourne, 35 Victoria Parade Fitzroy VIC 3065
Country 54976 0
Australia
Phone 54976 0
+61 3 9231 2211
Fax 54976 0
Email 54976 0
sybil.mcauley@svha.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary