How does Flash Glucose Monitoring affect Blood Glucose Levels of Indigenous Australians with type 2 diabetes?- A Pilot Study.

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2021
INTERVENTION: This is a randomised clinical trial. Participants will be randomised to either (intervention) FreeStyle® Libre™ flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) or usual care of self‐monitoring blood glucose (SMBG) for 6 months. Participants will be required to attend the study site at visits 0,3 and 6 months. Participants in both the intervention and usual care group will wear the Flash Libre Pro blinded sensor for 2 weeks prior to randomisation to the intervention or usual care group. 2 weeks prior to completion of the study (2 weeks prior to the 6 month visit) participants will wear the Flash Libre Pro blinded sensor. For participants in the usual care group, after partaking in the final study visit, will be offered flash glucose monitoring for 6 months. For Participants in the Flash Glucose Monitoring (INTERVENTION ARM): Participants will be provided with a FreeStyle Libre flash glucose monitoring system and will be required to apply a sensor to their upper arm. The sensor will be changed by the participant every 2 weeks and participants will be provided with sufficient sensors to enable this process throughout the 6 months study period. Participants may choose to continue undertaking self‐monitoring of blood glucose in addition to wearing the sensor, however this is not required for the trial. Trial visits are expected to take between 30 minutes to 1 hour. The blinded sensor we will be using is called the FreeStyle Libre Pro (https://www.freestyle.abbott/in‐en/products/freestyle‐libre‐pro.html). The FreeStyle Libre Pro is used for healthcare professionals only. A participant wearing the blinded sensor (FreeStyle Libre Pro) only requires one scan of the sensor upon insertion and one scan of the sensor prior to removal (14 CONDITION: Diabetes;type 2 diabetes; ; Diabetes ; type 2 diabetes Metabolic and Endocrine ‐ Diabetes PRIMARY OUTCOME: Change in HbA1c level from baseline to 6 months assessed using blood tests. [Change in HbA1c level from baseline (study visit 0) to 6 months (final visit) assessed using blood tests. ] SECONDARY OUTCOME: Change in percent of time spent in target glucose (4‐10mmol/L), low glucose (<3.9mmol/L) and high glucose (>15mmol/L) from baseline to 6 months (blinded sensor). This data is collected using the blinded sensors.[Baseline (study visit at 0 months) to 6 months (final visit). ] Cost‐effectiveness analysis using the EQ‐5D. [All collected data will be assessed from visit 3(randomisation visit), visit 4 (3 month visit) to 6 months (final visit) post‐commencement of intervention.] INCLUSION CRITERIA: Indigenous Australians with type 2 diabetes and HbA1c greater than or equal to 7.0% (53mmol/L) AND one of the following: ‐ Injectable therapy (including insulin) ± oral hypoglycaemic agent, or ‐ GLP‐1 analogue ± oral hypoglycaemia agent, or ‐ GLP‐1 analogue and insulin ± oral hypoglycaemic agent
Epistemonikos ID: 72f07dbba8733b8be8f740e54453dafa855e3112
First added on: Aug 24, 2024