ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

FLASH-CGM

Linked study record

Health condition

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

Diabetes

Condition category

Condition code

Metabolic and Endocrine

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]

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]

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]

3 months post-intervention commencement, continuously monitoring blood glucose (FCGM measures glucose every 5 minutes)

Secondary outcome [1]

HbA1c assessed by blood test

Timepoint [1]