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Trial registered on ANZCTR


Registration number
ACTRN12621001661864
Ethics application status
Approved
Date submitted
12/10/2021
Date registered
2/12/2021
Date last updated
2/12/2021
Date data sharing statement initially provided
2/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
FLASH-CGM – investigating the effect of flash glucose monitoring on glycaemic profile in patients with insulin-treated type 2 diabetes in the post-discharge setting; a randomized pragmatic trial
Scientific title
FLASH-CGM – investigating the effect of flash glucose monitoring on glycaemic profile in patients with insulin-treated type 2 diabetes in the post-discharge setting; a randomized pragmatic trial
Secondary ID [1] 305534 0
Nil
Universal Trial Number (UTN)
Trial acronym
FLASH-CGM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 323925 0
Condition category
Condition code
Metabolic and Endocrine 321438 321438 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized pragmatic trial comparing flash glucose monitoring to care as usual in a group of acutely unwell people with type 2 diabetes requiring insulin. Flash glucose monitoring is a form of continuous glucose monitoring (CGM) that continuously measures interstitial glucose while the sensor is implanted into a patient. Flash CGM use the same basic technology, but require the patient to ‘flash’ the sensor with a reading device every 8 hours to read the data that is gathered in the continuous monitoring

Sensors will be inserted by trained clinical staff at the hospital, in a short appointment (<15 minutes) before discharge and worn for 2 weeks. The sensors do not need to be changed. Sensors will be monitored by accessing sensor analytics and self-monitored blood glucose during the trial.

The intervention group, at 3 months, will have a FCGM sensor inserted by a diabetes educator, and the reader set up to read the sensor, again in a short outpatient appointment expected to take <15 minutes. All will be educated again on how to use FCGM. They will also be again advised to check SMBG during times of rapidly changing glucose levels when FCGM may not accurately reflect glucose levels or if hypoglycaemia <4 mmol/L or impending hypoglycaemia is reported by FCGM or if the symptoms do not match the FCGM readings. They will have to return to have the sensor removed by a diabetes educator two weeks later. Again, as part of usual management of Flash-CGM, and as a safety measure, any severe hypoglycaemia will be addressed at the time.

The discussion about FCGM results will take place as part of clinical appointments about diabetes, and is expected to take no more than the usual appointment time of 30 minutes.
Intervention code [1] 321933 0
Treatment: Devices
Comparator / control treatment
Blinded CGM/Care as Usual
The non-intervention group will be asked, as part of routine care, to check and record fingerprick glucose levels, a minimum of four-times a day.

All patients, the intervention group and non-blinded control group, will then have their scheduled consultation with the study endocrinologist and team, as per care as usual, with education about diabetes and discussion of medications. Intervention group will have discussion of flash CGM results + care as usual. The non-blinded control arm will get care as usual, which will be part of the regular treatment protocols of the discharge clinic. Diabetes distress will be managed by addressing that during the consult as well as referral to a psychologist via the patient’s GP.

All non-blinded control group, at 3 months, will have a FCGM sensor inserted by a diabetes educator, and the reader set up to read the sensor, during a short outpatient appointment expected to take <15 minutes. All will be educated again on how to use FCGM. They will also be again advised to check SMBG during times of rapidly changing glucose levels when FCGM may not accurately reflect glucose levels or if hypoglycaemia <4 mmol/L or impending hypoglycaemia is reported by FCGM or if the symptoms do not match the FCGM readings. They will have to return to have the sensor removed by a diabetes educator two weeks later. Again, as part of usual management of Flash-CGM, and as a safety measure, any severe hypoglycaemia will be addressed at the time.

The discussion about FCGM results will take place as part of clinical appointments about diabetes, and is expected to take no more than the usual appointment time of 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 329221 0
Time in range as assessed using the fCGM and CGM systems described prior. The optimum glucose range specified for these devices is 4-10.
Timepoint [1] 329221 0
3 months post-intervention commencement, continuously monitoring blood glucose (FCGM measures glucose every 5 minutes)
Secondary outcome [1] 401809 0
HbA1c assessed by blood test
Timepoint [1] 401809 0
Baseline and 3 months post-intervention commencement
Secondary outcome [2] 402491 0
eGFR assessed by blood test
Timepoint [2] 402491 0
Baseline and 3 months post-intervention commencement
Secondary outcome [3] 402492 0
BMI assessed by weight/height of patient collected in clinics
Timepoint [3] 402492 0
Baseline and 3 months post-intervention commencement
Secondary outcome [4] 402493 0
Hypo/hyperglycemia assessed using sensor downloads
Timepoint [4] 402493 0
Baseline and 3 months post-intervention commencement
Secondary outcome [5] 402494 0
Lipids assessed using blood tests
Timepoint [5] 402494 0
Baseline and 3 months post-intervention commencement
Secondary outcome [6] 402495 0
Diabetes distress assessed using the Diabetes Distress Score
Timepoint [6] 402495 0
Baseline and 3 months post-intervention commencement
Secondary outcome [7] 402496 0
Healthcare utilization assessed using routine hospital data
Timepoint [7] 402496 0
Baseline and 3 months post-intervention commencement
Secondary outcome [8] 402497 0
Cost of healthcare assessed using routine hospital data
Timepoint [8] 402497 0
Baseline and 3 months post-intervention commencement

Eligibility
Key inclusion criteria
1. Age 18-80 years of age
2. Have a diagnosis of type 2 diabetes mellitus with (HbA1c > 6.5%).
3. Utilizing insulin
4. Attending the diabetes discharge clinic at Blacktown Hospital
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with: Type 1 diabetes; pregnant or planning pregnancy; significant alcohol or drug abuse; severe/untreated mental health illnesses, including eating disorders; advanced cardiac, liver or renal disease, Type 2 diabetes not using insulin.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained by the study statistician, who will create the randomization schedule and inform investigators of the study group of each participant when they are consented into the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence will be generated by using a purpose-built program in Stata 15.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20723 0
Blacktown Hospital - Blacktown
Recruitment postcode(s) [1] 35529 0
2148 - Blacktown

Funding & Sponsors
Funding source category [1] 309903 0
Hospital
Name [1] 309903 0
Blacktown Hospital
Country [1] 309903 0
Australia
Primary sponsor type
Hospital
Name
Blacktown Hospital
Address
18 Blacktown Road, Blacktown, 2148, NSW
Country
Australia
Secondary sponsor category [1] 310934 0
None
Name [1] 310934 0
Address [1] 310934 0
Country [1] 310934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309624 0
Western Sydney Local Health District HREC
Ethics committee address [1] 309624 0
Ethics committee country [1] 309624 0
Australia
Date submitted for ethics approval [1] 309624 0
Approval date [1] 309624 0
09/09/2021
Ethics approval number [1] 309624 0

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

Contacts
Principal investigator
Name 114814 0
Dr Rajini Jayaballa
Address 114814 0
Level 3, Admin and Education Building, Blacktown Hospital, 18 Blacktown Road, Blacktown NSW 2148
Country 114814 0
Australia
Phone 114814 0
+61 2 86700016
Fax 114814 0
Email 114814 0
Rajini.Jayaballa@health.nsw.gov.au
Contact person for public queries
Name 114815 0
Gideon Meyerowitz-Katz
Address 114815 0
Level 3, Admin and Education Building, Blacktown Hospital, 18 Blacktown Road, Blacktown NSW 2148
Country 114815 0
Australia
Phone 114815 0
+61 298818878
Fax 114815 0
Email 114815 0
gideon.meyerowitzkatz@health.nsw.gov.au
Contact person for scientific queries
Name 114816 0
Gideon Meyerowitz-Katz
Address 114816 0
Level 3, Admin and Education Building, Blacktown Hospital, 18 Blacktown Road, Blacktown NSW 2148
Country 114816 0
Australia
Phone 114816 0
+61 298818878
Fax 114816 0
Email 114816 0
gideon.meyerowitzkatz@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13528Study protocol    Email to corresponding researchers
13529Informed consent form    Email to corresponding researchers
13530Clinical study report    Email to corresponding researchers
13531Ethical approval    Email to corresponding researchers



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.