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

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.