Slide 1: Better Diagnostics for Life Management of Type 2 Diabetes using non-invasive CGM
Better Diagnostics for Life Management of Type 2 Diabetes using non - invasive CGM 11 th May 2020
Slide 2: Authors
2 Authors Dr R K Ibrahim Head of data analytics Mr Steve Willmor Head of Regulatory
Slide 3: Summary of Presentation
3 Summary of Presentation There is compelling evidence suggesting Type 2 diabetes may be managed by use of a Continuous Glucose Monitor (CGM) on non - consecutive days, leading to clinically significant outcomes. Invasive CGMs are generally designed for wear periods of up to 14 consecutive days, wit
Slide 4: Volunteer User Feedback Objectives
4 Volunteer User Feedback Objectives Primary objective: To establish whether use of continuous glucose monitoring (CGM) a few days a week or month could lead to the same long term clinical outcome in terms of reduction in HbA1C and improved quality of life, as continuous wear of a CGM for up to 14 c
Slide 5: The Benefits of using CGM in Type 2 Diabetes on intermittent or non-consecutive days
5 The Benefits of using CGM in Type 2 Diabetes on intermittent or non - consecutive days Currently there are no known devices other than sugarBEAT® that allow non - consecutive day use of a CGM. Invasive CGMs such as the Abbott Libre® and Dexcom® can be used by persons with Type 2 diabetes though th
Slide 6: Evidence for intensive Finger stick testing in Type 2 diabetes leading to positive long term outcomes
6 Evidence for intensive Finger stick testing in Type 2 diabetes leading to positive long term outcomes 1. 6 - point glucose profiles two days per week. Counselling provided on diet and exercise [1] . Outcome: Significantly greater reduction in HbA1c. Marked improvement in general well - being, with
Slide 7: Evidence for intensive Finger stick testing in Type 2 diabetes (cont'd)
7 Evidence for intensive Finger stick testing in Type 2 leading to positive long term outcomes cnt’d 4. 7 - point glucose profiles over 3 consecutive days per month. Education on device use and data collection using a paper tool. Basic education on use of SMBG to alter diet and physical activity [4]
Slide 8: Evidence for intensive Finger stick testing in Type 2 diabetes (cont'd)
8 Evidence for intensive Finger stick testing in Type 2 leading to positive long term outcomes cnt’d The above independent study outcomes provide compelling evidence for the use of a CGM on non - consecutive days or a few consecutive days per month, to provide clinically significant outcomes in the
Slide 9: Synopsis of accuracy of sugarBEAT in a real-life setting
9 Synopsis of accuracy of sugarBEAT® in a real - life setting Comparison of accuracy in terms of %MARD shown over 10 - 14 hours use per day. Finger prick taken with Accu - chek ® blood glucose meter, on a minimum of 8 times and maximum 12 times per wear period / day. Results indicate accuracy of sug
Slide 10: Conclusions
10 Conclusions There is compelling evidence from a number of studies suggesting Type 2 diabetes may be managed by CGM usage on non - consecutive days, leading to clinically significant outcomes. sugarBEAT ® is ideally positioned to cater for the Type 2 Diabetic population given it allows monitoring
Slide 11: Examples of sugarBEAT profiles
11 Examples of sugarBEAT ® profiles sugarBEAT MARD: 16.43% Invasive CGM MARD: 17.28% sugarBEAT MARD: 10.71% Invasive CGM MARD: 8.18%
Slide 12: Examples of sugarBEAT profiles
12 Examples of sugarBEAT ® profiles sugarBEAT MARD: 9.69% Invasive CGM MARD: 9.24% sugarBEAT MARD: 12.18% Invasive CGM MARD: 13.59%
Slide 13: References
13 References 1. Schwedes U, Siebolds M, Mertes G: Meal - related structured self - monitoring of blood glucose: effect on diabetes control in non - insulin - treated type 2 diabetic patients. Diabetes Care 2002;25:1928 – 1932 2. Durán A, Martín P, Runkle I, Pérez N, Abad R, Fernández M, Del Valle L