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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 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]

NIL

Universal Trial Number (UTN)

U1111-1190-6146

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

diabetes

severe hypoglycaemia

Condition category

Condition code

Metabolic and Endocrine

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]

Treatment: Devices

Intervention code [2]

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]

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]

The number of episodes of recurrent severe hypoglycaemia over a 6-month period.

Secondary outcome [1]

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]

The number of episodes of recurrent non-severe hypoglycaemia over a 6-month period.

Secondary outcome [2]

Time to first recurrence of severe hypoglycaemia

Timepoint [2]

The time between recruitment to the study and first recurrence of severe hypoglycaemia within the 6-month follow-up period.

Secondary outcome [3]

Time to first occurrence of non-severe hypoglycaemia

Timepoint [3]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Fiona Stanley Hospital - Murdoch

Recruitment hospital [2]

Fremantle Hospital and Health Service - Fremantle

Recruitment postcode(s) [1]

6150 - Murdoch

Recruitment postcode(s) [2]

6160 - Fremantle

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Spinnaker Health Research Foundation

Address [1]

Fremantle Hospital, Alma St, Fremantle, WA 6160

Country [1]

Australia

Primary sponsor type

University

Name

University of Western Australia

Address

35 Stirling Highway, Perth WA 6009

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Metropolitan Health Service Human Research Ethics Committee

Ethics committee address [1]

11 Robin Warren Drive, Murdoch WA 6150

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/12/2016

Approval date [1]

27/03/2017

Ethics approval number [1]

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

Prof Timothy Davis

Address

University of Western Australia, School of Medicine and Pharmacology, Fremantle Hospital, P.O. Box 480, Fremantle, Western Australia 6959

Country

Australia

Phone

+618 9431 3229

Fax

[email protected]

Contact person for public queries

Name

Timothy Davis

Address

University of Western Australia, School of Medicine and Pharmacology, Fremantle Hospital, P.O. Box 480, Fremantle, Western Australia 6959

Country

Australia

Phone

+618 9431 3229

Fax

[email protected]

Contact person for scientific queries

Name

Timothy Davis

Address

University of Western Australia, School of Medicine and Pharmacology, Fremantle Hospital, P.O. Box 480, Fremantle, Western Australia 6959

Country

Australia

Phone

+618 9431 3229

Fax

[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.	Type	Email
11957	Other	[email protected]
11959	Study protocol	[email protected]
11960	Statistical analysis plan	[email protected]
11961	Informed consent form	[email protected]
11962	Clinical study report	[email protected]
11963	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy of Intermittently Scanned Continuous Glucose Monitoring in the Prevention of Recurrent Severe Hypoglycemia.	2020	https://dx.doi.org/10.1089/dia.2019.0331

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically