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Trial registered on ANZCTR


Registration number
ACTRN12616001695493
Ethics application status
Approved
Date submitted
6/12/2016
Date registered
9/12/2016
Date last updated
8/06/2021
Date data sharing statement initially provided
8/06/2021
Date results information initially provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can we prevent recurrent severe low blood glucose reactions using a new glucose sensing device?
Scientific title
Assessment of the utility of the Flash Libre subcutaneous glucose monitoring system to prevent recurrent severe hypoglycaemia in patients with diabetes
Secondary ID [1] 290694 0
NIL
Universal Trial Number (UTN)
U1111-1190-6146
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
diabetes 301239 0
severe hypoglycaemia 301240 0
Condition category
Condition code
Metabolic and Endocrine 300998 300998 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with a documented episode of severe hypoglycaemia will be randomised to the Flash Libre subcutaneous glucose sensing system or usual care over a 6-month follow-up period. The Flash Libre device is an adhesive sensor disc with a thin needle that is placed on the upper arm and which can be read as required. Each sensor lasts 2 weeks before it has to be replaced (patients allocated to this arm will be using the device continuously for 6 months) and is precalibrated so that the patient does not need to do any finger prick blood glucose readings. The readings can be downloaded to a PC which will also be access by the Study Nurse to assess compliance. Training on use of the Flash Libre system will be implemented by the Study Nurse but the patients themselves will insert each sensor, and perform data collection at least 4 times per day and when a hypoglycaemic episode is suspected. The Research Nurse will also co-ordinate usual care for those randomised to this arm. Both intervention (Flash Libre) and usual care patients will have a 30-minute face-to-face session with the Research Nurse as soon as possible after the index severe hypoglycaemic episode. The Nurse will perform a review of medication and self blood glucose monitoring, re-educate patients as to avoidance measures and ensure that the patient's usual health care professionals are aware of the hypoglycaemic episode so that they can take over care in the community.
Intervention code [1] 296575 0
Treatment: Devices
Intervention code [2] 296576 0
Prevention
Comparator / control treatment
Usual care from multidisciplinary diabetes team (including Endocrinologist, Diabetes Nurse Educator and Dietitian) comprising blood glucose medication and self blood glucose monitoring review, re-education on avoidance measures such as ensuring meal regularity, diabetes treatment dose reduction when physically active etc.
Control group
Active

Outcomes
Primary outcome [1] 300416 0
Recurrence of severe hypoglycaemia defined as a hypoglycaemic episode requiring second party assistance with or without a documented blood or subcutaneous glucose <3.9 mmol/L as per American Diabetes Association guidelines.
Timepoint [1] 300416 0
The number of episodes of recurrent severe hypoglycaemia over a 6-month period.
Secondary outcome [1] 329923 0
Occurrence of non-severe hypoglycaemia (that not requiring second part assistance with appropriate symptoms with or without a documented blood or subcutaneous glucose <3.9 mmol/L).
Timepoint [1] 329923 0
The number of episodes of recurrent non-severe hypoglycaemia over a 6-month period.
Secondary outcome [2] 330022 0
Time to first recurrence of severe hypoglycaemia
Timepoint [2] 330022 0
The time between recruitment to the study and first recurrence of severe hypoglycaemia within the 6-month follow-up period.
Secondary outcome [3] 330023 0
Time to first occurrence of non-severe hypoglycaemia
Timepoint [3] 330023 0
The time between recruitment to the study and first occurrence of non-severe hypoglycaemia within the 6-month follow-up period.

Eligibility
Key inclusion criteria
Adults with diabetes who experiencean episode of severe hypoglycaemia as an inpatient or who attend the Emergency Department with severe hypoglycaemia
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not able to operate the Flash Libre device due to cognitive or visual impairment. Allergy to the adhesive used to attach the sensor in place,

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
We hypothesise that 40% of the patients in the usual care group will experience an episode of severe hypoglycaemia during six months of follow-up and that this will be reduced to 10% in the Flash Libre group. The sample size necessary to show this difference with 80% power and a one-tailed level of significance of 5% is 29 in each group or n=58 total. We will increase this by 10% to 64 total to allow for attrition, Kaplan Meier analysis with log rank test will determine whether there are intervention-related differences in time to primary and secondary endpoints.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2017
Actual
1/09/2017
Date of last participant enrolment
Anticipated
1/09/2017
Actual
2/07/2018
Date of last data collection
Anticipated
1/06/2018
Actual
21/12/2018
Sample size
Target
64
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7075 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 7076 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 14802 0
6150 - Murdoch
Recruitment postcode(s) [2] 14803 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 295118 0
Charities/Societies/Foundations
Name [1] 295118 0
Spinnaker Health Research Foundation
Country [1] 295118 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Highway, Perth WA 6009
Country
Australia
Secondary sponsor category [1] 293938 0
None
Name [1] 293938 0
Address [1] 293938 0
Country [1] 293938 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296470 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 296470 0
11 Robin Warren Drive, Murdoch WA 6150
Ethics committee country [1] 296470 0
Australia
Date submitted for ethics approval [1] 296470 0
08/12/2016
Approval date [1] 296470 0
27/03/2017
Ethics approval number [1] 296470 0
RGS0000000001

Summary
Brief summary
This study will determine whether a new relatively non-invasive glucose monitoring system (Flash Libre) helps adults with diabetes who have a severe glucose reaction to avoid further such episodes. The hypothesis is that the non-invasive system will be superior to usual care in preventing both severe and non-severe hypoglycaemia after the index severe hypoglcyaemic event.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70970 0
Prof Timothy Davis
Address 70970 0
University of Western Australia, School of Medicine and Pharmacology, Fremantle Hospital, P.O. Box 480, Fremantle, Western Australia 6959
Country 70970 0
Australia
Phone 70970 0
+618 9431 3229
Fax 70970 0
Email 70970 0
[email protected]
Contact person for public queries
Name 70971 0
Timothy Davis
Address 70971 0
University of Western Australia, School of Medicine and Pharmacology, Fremantle Hospital, P.O. Box 480, Fremantle, Western Australia 6959
Country 70971 0
Australia
Phone 70971 0
+618 9431 3229
Fax 70971 0
Email 70971 0
[email protected]
Contact person for scientific queries
Name 70972 0
Timothy Davis
Address 70972 0
University of Western Australia, School of Medicine and Pharmacology, Fremantle Hospital, P.O. Box 480, Fremantle, Western Australia 6959
Country 70972 0
Australia
Phone 70972 0
+618 9431 3229
Fax 70972 0
Email 70972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All deidentified study data
When will data be available (start and end dates)?
1/1/2020 to 31/12/2020
Available to whom?
Bona fide researchers with a valid research question
Available for what types of analyses?
Deidentified analyses not already performed by the investigators
How or where can data be obtained?
Through the PI ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11957Other  [email protected]
11959Study protocol  [email protected]
11960Statistical analysis plan  [email protected]
11961Informed consent form  [email protected]
11962Clinical study report  [email protected]
11963Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of Intermittently Scanned Continuous Glucose Monitoring in the Prevention of Recurrent Severe Hypoglycemia.2020https://dx.doi.org/10.1089/dia.2019.0331
N.B. These documents automatically identified may not have been verified by the study sponsor.