At a glance
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IMpact of Flash Glucose Monitoring in pEople With Type 2 Diabetes Inadequately Controlled With Non-insulin Antihyperglycemic ThErapy - IMMEDIATE Study
In Brief
A clinical study evaluating FreeStyle Libre Flash Glucose Monitor and Diabetes self-management education for Diabetes Mellitus, Type 2 and Glucose. Completed, enrolled 116 participants across 6 sites.
Detailed Summary
The objective of this study is to evaluate the effectiveness of a flash glucose monitor device in achieving optimal glycemic control among adults with type 2 diabetes inadequately controlled with non-insulin antihyperglycemic therapy.
Study Details
Timeline
Interventions
The FreeStyle Libre FGM device consists of a skin-worn disposable sensor that automatically measures and continuously stores glucose readings. The sensor is placed by a single-use applicator and is activated by a wireless scan with a handheld reader. It is designed to stay on the body for up to 14 days, and can be worn under clothing. After a 1-hour warm-up period, the sensor takes automatic measurements of glucose every 15 minutes for up to 14 days. The device collects the interstitial glucose values and stores them for subsequent upload at the end of the 14-day wear period. With each scan, users receive their glucose reading; the last eight hours of glucose data; and an arrow illustrating the direction their glucose is heading.
The DSME curriculum is compromised of: 1. Review of weekly glucose report (Trend glucose report from Libreview for intervention group; and weekly glucose report in log book format from their glucose monitoring software for control group) 2. Education modules for both in-person and remote delivery; 3. Handouts to support the curriculum objectives; and 4. Blood glucose monitoring challenges to stimulate behaviour change and reinforce learning.