Accuracy of a novel real-time continuous glucose monitoring system: a prospective self-controlled study in thirty hospitalized patients with type 2 diabetes.

Aims: The present study aimed to investigate the accuracy of the Glunovo® real-time continuous glucose monitoring system (rtCGMS). Methods: We conducted a 14-day interstitial glucose level monitoring using Glunovo® rtCGMS on thirty hospitalized patients with type 2 diabetes. The flash glucose monitoring (FGM) was used as a self-control. Consistency tests, error grid analysis, and calculation of the mean absolute relative difference (MARD) were performed using R software to assess the accuracy of Glunovo® rtCGMS. Results: Glunovo® exhibited an overall MARD value of 8.89% during hospitalization, compared to 10.42% for FGM. The overall percentages of glucose values within ±10%/10, ± 15%/15, ± 20%/20, ± 30%/30, and ±40%/40 of the venous blood glucose reference value were 63.34%, 81.31%, 90.50%, 97.29%, and 99.36% for Glunovo®, respectively, compared with 61.58%, 79.63%, 88.31%, 96.22% and 99.23% for FGM. The Clarke Error Grid Analysis showed that 99.61% of Glunovo® glucose pairs and 100.00% of FGM glucose pairs within zones A and B. Conclusion: Our study confirms the superior accuracy of Glunovo® in monitoring blood glucose levels among hospitalized patients with type 2 diabetes.

Performance Evaluation of the Glunovo® Continuous Blood Glucose Monitoring System in Chinese Participants with Diabetes: A Multicenter, Self-Controlled Trial.

INTRODUCTION: The present study was aimed to evaluate the performance and safety of the Glunovo® real-time continuous glucose monitoring system (CGMS) in monitoring interstitial fluid glucose in adult participants with diabetes (at least 18 years old) using venous blood glucose as control. METHODS: This was a multicenter, self-controlled clinical trial, conducted in participants with diabetes from China, between March 2019 to October 2019. The CGMS was used by all the participants for a 14-day wear-in period. The real-time glucose values measured by Glunovo® CGMS were compared with venous blood glucose values measured by the Entwicklung, Konstruktion und Fertigung (EKF) blood glucose detector. The primary outcomes were the consistency rate of CGMS readings and venous blood glucose values (20/20% standard). RESULTS: A total of 78 participants (41 men, 37 women) and 156 CGMS sensors were included in the study. Among the included participants, 25 and 53 participants had type 1 and type 2 diabetes, respectively, with median age of 52.50 years (range 32-62 years). The overall agreement rate (20/20%) was 89.71% (95% CI 89.18-90.24%). It was observed that 99.08% (95% CI 98.91-99.24%) and 99.82% (95% CI 99.74-99.89%) of the measuring points fell within the A + B zones of the Clarke error grid analysis and Parkes/consensus error grid analysis, respectively. The mean absolute relative difference was 10.30% ± 4.86%. The probability of a glucose measurement falling within a range, when stratified by venous glucose measurements, ranged from 7.14% for 19.44-22.22 mmol/L to 79.21% for 4.44-6.67 mmol/L. There were 73 (41.24%) and 27 (57.45%) successful CGMS alarms for hypoglycemic and hyperglycemic events, respectively. CONCLUSION: From the results, Glunovo® CGMS had excellent accuracy and limited clinical risk compared with venous blood glucose in the range of 2.2-22.2 mmol/L over 14 days.

Prevalence and cost of possibly unnecessary venous blood glucose measurements in primary care.

The American Diabetes Association issues annually its recommendations for diabetes mellitus screening. Although there is a high proportion of people with undiagnosed diabetes in the general population, it is suspected that many of these screening tests could be needless. An analysis was made of the number of venous blood glucose measurements that did not meet the American Diabetes Association requirements performed in 150 people seen in primary care. On average, an unnecessary venous blood glucose measurement is performed every 15 months. The number is significantly higher in people over 45 years of age, and also in women as compared to men (although with a p value slighty higher than 0.05).

Níveis glicêmicos de pacientes diabéticos segundo estudo comparativo entre duas técnicas. / Blood glucose levels of diabetic patients: comparative study of two measuring techniques

O estudo teve como objetivo identificar e comparar os resultados de glicemia de pacientes adultos com diabetes tipo 2 por meio de duas técnicas, laboratorial e capilar. Estudo comparativo foi desenvolvido no período de setembro a dezembro de 2007. A população foi constituída de 36 pacientes adultos residentes no município de Planaltina do Paraná, PR. A pesquisa foi realizada no laboratório de análises clínicas municipal. Para o exame laboratorial foi usado o sangue venoso e para o teste capilar o sangue da ponta do dedo. A maioria dos pacientes (63,9%) era do gênero feminino, idade média de 62,4 anos. Quanto à escolaridade, 41,6% dos pacientes possuíam menos de 8 anos de estudo. Em relação aos níveis glicêmicos, o p-valor do teste Kappa foi significativo em todas as categorias (p< 0,001, p=0,005 e p=0,001), mostrando concordância. Os dados indicam elevada precisão e acurácia dos resultados de glicemia obtidos por meio do glicosímetro, quando comparada ao teste padrão obtido em laboratório.

The goal of this research was to measure the blood glucose levels of type 2 diabetic adult patients and compare the results obtained by two techniques, the standard laboratory (venous) and portable glucometer (capillary) tests. A comparative longitudinal study was conducted from September to December 2007. The study population consisted of 36 resident adult patients in the town of Planaltina do Paraná in upstate Paraná, Brazil. The tests were performed in the local health authority clinical laboratory. For the lab test, venous blood from the arm was used, and for the glucometer test, capillary blood from the fingertip. Most of the patients (63.9%) were women and the average age was 62.4 years. Regarding education, 41.6% of the patients had studied for less than 8 years. Comparing the glucose measurements, the results of the Kappa test were significant in all categories (p<0.001, p=0.005 and p=0.001), showing very good agreement between the methods. The findings indicate a high level of precision and accuracy for the blood glucose readings obtained with the glucometer, compared with the standard test carried out in the laboratory.