Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Elsayed, H.
Evaluation of Subcutaneous Glucose Monitoring Systems under Routine Environmental Conditions
Humanmedizin; [ Diplomarbeit ] Graz Medical University; 2017. pp. 80
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- Autor*innen der Med Uni Graz:
- Elsayed Hesham
- Betreuer*innen:
- Mader Julia
- Theiler-Schwetz Verena
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- Abstract:
- Background: Since the incidence of both diabetes mellitus type 1 and type 2 are increasing rapidly, the WHO and ADA are estimating up to 1.5 million deaths annually, which are directly linked to the disease. In order to prevent side effects and metabolic deficiencies, and in order to increase quality of life, it is necessary to establish an adequate insulin therapy to achieve normoglycemia in insulin-dependent diabetes. Since continuous glucose monitoring systems (CGM) are established in modern diabetes management, research focuses on the improvement of already existing sensor technologies or the development of new, less invasive measuring methods, which should largely influence therapies positively and thus ensure a high standard living. In the following open-label, single-center study, the performance of Abbott FreeStyle libre, Dexcom G4 Platinum and Medtronic MiniMed 640G, three CGM systems that are already available on the market, were compared in a head-to-head comparison. Material und Methods: Twelve subjects with diabetes mellitus type 1 (T1D) participated in this monocentric, open-label trial. Main inclusion criteria were: diagnosis of T1D at least 6 months prior to the study, insulin treatment with insulin pen or pump for at least 3 months, body mass index < 35kg/m² und glycated hemoglobin level <8.4%. Main exclusion criteria were: pregnancy, medical conditions influencing glucose metabolism other than T1D and use of medication that impacts glucose metabolism other than insulin therapy. The study was performed at the clinical research center at the Medical University of Graz and was approved by the ethical committee of Medical University of Graz. Sensor performance was determined by fulfillment of ISO 15197:2013 criteria, calculating mean absolute relative difference (MARD) for Abbott, Dexcom and Medtronic and illustrated by Parkes Error Grid (PEG). Primary aim of the study was to evaluate the accuracy and reliability of three CGM systems. Primary Outcome: Abbott, Dexcom and Medtronic fulfilled ISO criteria by 73.2%, 56.1% and 52.0%. The MARD for Abbott was 13.2 ± 10.9%, for Dexcom 16.8% ± 12.3% and for Medtronic 17.6%. Illustrated by PEG, 99.3% of reference pairs of Abbott, 99.3% of Dexcom and 98.6% of Medtronic fell within zones A and B. Discussion: FreeStyle libre by Abbott has shown the best sensor performance in all glycemic ranges, however there is a need for improvement in future generations of all tested devices, especially in the hypoglycemic range.