Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System

Background: Blood glucose monitoring (BGM) is essential for glycemic control in diabetic therapy. Followingly, accurate sensors are required for both daily personal and clinical use. The frequency of sensor use in patients with diabetes facilitates the use of disposable components. However, BGM systems are not exempt from green innovation sustainability initiatives. Methods: Clinical study of a high-accuracy green design blood glucose monitor using an innovative optical transmission absorbance system was carried out. Venous blood samples were collected from 104 patients with type II diabetes. The heat resistance of sensor strips was evaluated by storing sensor strips at 25℃ and 60℃ for approximately 3 months. Accuracy of the BGM system was evaluated via the ISO 15197:2013 protocol. Results: The BGM system achieved ±7.1% accuracy in glycemic level measurement, with 84% of all measurements within ±5% of the reference values. Furthermore, the sensor strip demonstrated heat resistance for more than 3 months when stored at 60℃. Conclusions: A new, highly accurate BGM system was developed based on the latest optical measurement system, introducing a rare metal-free “green-strip.” The developed BGM system achieved the highest reported accuracy in clinical research, using venous blood from patients with diabetes. The sensor strip also exhibited high heat resistance, reducing limitations on storage conditions.

Evaluation of a Continuous Blood Glucose Monitor: A Novel and Non-Invasive Wearable Using Bioimpedance Technology

Background: Frequent blood glucose level (BGL) monitoring is essential for effective diabetes management. Poor compliance is common due to the painful finger pricking or subcutaneous lancet implantation required from existing technologies. There are currently no commercially available non-invasive devices that can effectively measure BGL. In this real-world study, a prototype non-invasive continuous glucose monitoring system (NI-CGM) developed as a wearable ring was used to collect bioimpedance data. The aim was to develop a mathematical model that could use these bioimpedance data to estimate BGL in real time. Methods: The prototype NI-CGM was worn by 14 adult participants with type 2 diabetes for 14 days in an observational clinical study. Bioimpedance data were collected alongside paired BGL measurements taken with a Food and Drug Administration (FDA)-approved self-monitoring blood glucose (SMBG) meter and an FDA-approved CGM. The SMBG meter data were used to improve CGM accuracy, and CGM data to develop the mathematical model. Results: A gradient boosted model was developed using a randomized 80-20 training-test split of data. The estimated BGL from the model had a Mean Absolute Relative Difference (MARD) of 17.9%, with the Parkes error grid (PEG) analysis showing 99% of values in clinically acceptable zones A and B. Conclusions: This study demonstrated the reliability of the prototype NI-CGM at collecting bioimpedance data in a real-world scenario. These data were used to train a model that could successfully estimate BGL with a promising MARD and clinically relevant PEG result. These results will enable continued development of the prototype NI-CGM as a wearable ring.

Senam Prolanis Dm Dan Jalan Kaki Terhadap Penurunan Kadar Gula Darah Pada Penderita Diabetes Millitus Tipe II Di Klinik UMP Purwokerto

Diabetes mellitus is one of cronical degenerative disease. The prevalence of sufferers continues to increase every year, one of the non-pharmacological therapies is exercise such as gymnastics prolanis DM and walking exercises to decrease the glucose level by the body muscles during the physical body. Objective this research is to find out the effectiveness of Prolanis and walking exercises in reducing blood sugar levels in DM patients type II. Method this study uses the Quasi experiment with pre and post with two group design. The study population was 92 DM patients type II with a sample of 82 people. Glucometer (Auto check blood glucose monitor) is used to collect the data. Wiloxon Test is used to analyze the statistical data. Results the research shows that the value of Prolanis Exercises (DM) is p=0.002 which means a significant influence on decrease of the sugar level of DM patients type II. Meanwhile the value of walking exercises is p=0.001. From the statistic test of WIlconxon Signed Rank Test, It obtained Z correlation = 7.886. It means that there is a significant correlation between Prolanis and walking exercises towards the decrease of blood sugar level of Diabetes Mellitus patients type II. Physical activities done regularly, measurably, and correctly are suggested to be considered as non-pharmacological therapies for Diabetes Mellitus patients type II to decrease blood sugar level. Keywords: Prolanis Exercises (DM), Walking, sugar blood level.

Meeting the New FDA Standard for Accuracy of Self-Monitoring Blood Glucose Test Systems Intended for Home Use by Lay Users

The OneTouch Verio Reflect blood glucose monitor (BGM) has market clearance in several countries based in part on fulfilling the lay user and system accuracy criteria described in ISO15197:2015. However, the Food and Drug Administration (FDA) does not recognize the accuracy criteria in ISO15197 as a basis for gaining regulatory clearance for these devices. The current study evaluates the BGM using the accuracy guidelines issued by the agency for self-monitoring blood glucose test systems for over-the-counter use. Glucose results were accurate vs comparator over a wide glucose range and met lay user and glucose accuracy criteria at extreme glucose values as described in the FDA guidance. Clinicaltrials.gov NCT03851549

Digital Diabetes Care System Observations from a Pilot Evaluation Study in Vietnam

Digital technologies are gaining an important role in the management of patients with diabetes. We assessed clinical outcomes and user satisfaction of incorporating a digital diabetes care system in diabetes clinics of a developing country. The system integrated a wireless blood glucose monitor that communicates data to any smartphone utilizing a patented acoustic data transfer method, a mobile-app, and cloud-based software that stores, analyzes, and presents data. Five hospital endocrinology clinics in Vietnam sequentially recruited all patients willing to join the study, providing they had a smartphone and access to internet connectivity. Face-to-face visits were conducted at baseline and at 12 weeks, with monthly digital visits scheduled in the interim and additional digital visits performed as needed. HbA1c levels were measured at baseline and at 12 weeks (±20 days). The study included 300 patients of whom 279 completed the evaluation. Average glucose levels declined from 170.4 ± 64.6 mg/dL in the first 2 weeks to 150.8 ± 53.2 mg/dL in the last 2 weeks (n = 221; p < 0.001). HbA1c levels at baseline and 12 weeks declined from 8.3% ± 1.9% to 7.6% ± 1.3% (n = 126; p < 0.001). The digital solution was broadly accepted by both patients and healthcare professionals and improved glycemic outcomes. The durability, scalability, and cost-effectiveness of this approach merits further study.

Digital Diabetes Care System Observations from a market acceptance evaluation study in Vietnam (Preprint)

BACKGROUND Digital technologies are gaining an important role in the management of patients with diabetes. The GlucoMe solution integrates multiple aspects of diabetes care: 1) Wireless blood glucose monitor - communicates glucose data automatically to any smartphone; 2) Mobile-app - securely transmits real-time blood glucose monitor data for cloud based analyses, and enables 2-way communication between patients and health care professionals; 3) Digital diabetes clinic – analyzes and presents data to the health care professional; and 4) Control tower software provides population management reports and sends individualized alerts. OBJECTIVE Assess clinical outcomes and user satisfaction of incorporating the GlucoMe digital solution in diabetes clinics of a developing country. METHODS Five hospital endocrinology clinics in Vietnam participated in a market acceptance evaluation pilot of the GlucoMe system. The clinics sequentially recruited all patients willing to join, so long as they had a smartphone and access to internet connectivity. Patients were provided with the GlucoMe app and blood glucose monitor and instructed in their use in individual or groups sessions. The digital diabetes clinic and control tower software were installed in the clinic computers. Face-to-face visits were conducted at baseline and at 12 weeks, with monthly digital visits scheduled in the interim and additional digital visits performed as needed. HbA1c levels were measured at baseline and at 12 weeks (±20 days). Treatment modification was at the discretion of the treating physician. Outcome measures included adherence to glucose monitoring, change in glycemic parameters and patient and physician satisfaction as assessed by questionnaires. Only patients completing the pilot were included in data analyses. RESULTS The study recruited 300 patients of whom 279 patients completed the evaluation. Dropout was due to change in internet access availability (18) or death (3). Adherence to glucose measurements gradually declined, yet, at study end 81% of the patients were measuring glucose at least once a week. Digital contact from the health care professional to the patient or vice-versa (excluding automated alerts) occurred in average every 6.2 days. Average glucose levels declined from 170.4±64.6 mg/dl in the first two weeks to 150.8±53.2 mg/dl in the last two weeks (P<0.001) (n=221). HbA1c levels at baseline and 12 weeks were available for only 126 of the patients and declined from 8.3±1.9% to 7.6±1.3 (P<0.001). Over 95% of the physicians and patients stated they would strongly support the broad usage of the GlucoMe platform in diabetes clinics across the country. CONCLUSIONS The GlucoMe digital solution was broadly accepted by both patients and health care professionals and improved glycemic outcomes. The digital platform yielded increased number of patient-health care professional interactions, yet of short duration, enabling judicious allocation of limited time resources. The durability, scalability and cost-effectiveness of this approach merit further study.