Effectiveness of mHealth management with an implantable glucose sensor and a mobile application among Chinese adults with type 2 diabetes.

INTRODUCTION: This study aimed to evaluate the effectiveness of mHealth management with an implantable glucose sensor and a mobile application among patients with type 2 diabetes mellitus (T2DM) in China. METHODS: A randomised controlled trial was carried out to compare the effectiveness of usual health management to mHealth management based on a model that consisted of the network platform, an implantable glucose sensor and a mobile app featuring guidance from general practitioners (GPs) over a four-week period. Patients (N=68) with T2DM were randomly divided into an intervention group and a control group. Before the intervention, there was no difference in body mass index (BMI), fasting blood glucose (FBG), postprandial two-hour blood glucose (2hPG) and glycosylated haemoglobin (HbA1c) between the intervention group and the control group (p>0.05). Patients in the control group received their usual health management, while patients in the intervention group received mHealth management. RESULTS: After health management, the mean BMI, FBG, 2hPG and HbA1c of the intervention group patients were all lower than those of the control group patients (p < 0.05), and the quality of life and self-management of the intervention group patients had significantly improved. DISCUSSION: mHealth management effectively showed significant reductions in BMI, FBG, 2hPG and HbA1c and improved quality of life and self-management among patients, which may be related to real-time feedback from an implantable glucose sensor and guidance from GPs through a mobile app. mHealth management is a very promising way to promote the health management of T2DM in China, and this study provides a point of reference for mHealth management abroad.

Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes.

BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group. CONCLUSIONS: In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313.).

Glucometer Usability for 65+ Type 2 Diabetes Patients: Insights on Physical and Cognitive Issues.

Background: Self-monitoring of blood glucose (SMBG) is of paramount relevance for type 2 diabetes mellitus (T2DM) patients. However, past evidence shows that there are physical and cognitive issues that might limit the usage of glucometers by T2DM patients aged 65 years and over. Objective: Our aim was to investigate the physical and cognitive issues related to the usage of glucometers by T2DM patients aged 65 years and over. Materials and Methods: The extant literature was analysed to define an original framework showing the logical nexus between physical and cognitive issues and quality of life. Then we collected evidence addressing the specific case of the Accu-Chek® Instant glucometer produced by Roche Diabetes Care GmbH, which implements new features claiming to improve usability. We conducted 30 interviews with T2DM patients aged 65 years and over, three interviews with senior nurses, and a focus group with three senior physicians and three senior nurses. Results: From the interviews, both patients and nurses declared that they were generally satisfied with the Accu-Chek® Instant glucometer's characteristics. In the focus group, the results were commented on and, in the light of some diverging answers, improvements have been set up for future implementation. Conclusions: Our study produces evidence and future suggestions about the usage of glucometers by type 2 diabetes patients aged 65 years and over.

Improving Equitable Access to Continuous Glucose Monitors for Alabama's Children with Type 1 Diabetes: A Quality Improvement Project.

Background: Continuous glucose monitors (CGMs) are a tool that can reduce the burden of self-monitoring of glucose values in children and adults with type 1 diabetes (T1D), are associated with improved glycemic control, and are associated with reduced fear of hypoglycemia. Unfortunately, disparities in access to CGM exist and rates of CGM access in Alabama in 2019 were below national averages. We aimed to increase CGM access and reduce disparities in access by race, insurance status, and high-risk diabetes status. Methods: Stakeholder input identified barriers to CGM access and defined the existing process. Process changes were implemented and studied for effect. Data were collected from the electronic health record to track rates of CGM access in patients aged 2 years and above with T1D for >3 months. Results: For the eligible population, rates of CGM access increased from a baseline of 50% to 82%. Rates for CGM access in patients with high-risk T1D increased from 34% to 85%. Disparity in CGM access for non-Hispanic Whites and non-Hispanic Blacks decreased from 18% to 6%. Disparity in CGM access for privately insured and Medicaid-insured patients decreased from 38% to 12%. Conclusions: Targeted quality improvement projects using stakeholder input can increase access to diabetes technology while reducing disparities. As technology advances, concerted efforts are needed to ensure equitable access to evolving therapies for all patients with T1D.

Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study.

The aim of this study was to evaluate the accuracy and usability of a novel continuous glucose monitoring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed the sensor performance of two GlucoMen® Day CGM systems worn simultaneously by eight participants with type 1 diabetes. Self-monitoring of blood glucose (SMBG) was performed regularly over 14 days at home. Participants underwent two standardized, 5-h meal challenges at the research center with frequent plasma glucose (PG) measurements using a laboratory reference (YSI) instrument. When comparing CGM to PG, the overall mean absolute relative difference (MARD) was 9.7 [2.6-14.6]%. The overall MARD for CGM vs. SMBG was 13.1 [3.5-18.6]%. The consensus error grid (CEG) analysis showed 98% of both CGM/PG and CGM/SMBG pairs in the clinically acceptable zones A and B. The analysis confirmed that GlucoMen® Day CGM meets the clinical requirements for state-of-the-art CGM. In addition, the needle-free insertion technology is well tolerated by users and reduces medical waste compared to conventional CGM systems.

Current provision and HCP experiences of remote care delivery and diabetes technology training for people with type 1 diabetes in the UK during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has led to the rapid implementation of remote care delivery in type 1 diabetes. We studied current modes of care delivery, healthcare professional experiences and impact on insulin pump training in type 1 diabetes care in the United Kingdom (UK). METHODS: The UK Diabetes Technology Network designed a 48-question survey aimed at healthcare professionals providing care in type 1 diabetes. RESULTS: One hundred and forty-three healthcare professionals (48% diabetes physicians, 52% diabetes educators and 88% working in adult services) from approximately 75 UK centres (52% university hospitals, 46% general and community hospitals), responded to the survey. Telephone consultations were the main modality of care delivery. There was a higher reported time taken for video consultations versus telephone (p < 0.001). Common barriers to remote consultations were patient familiarity with technology (72%) and access to patient device data (67%). We assessed the impact on insulin pump training. A reduction in total new pump starts (73%) and renewals (61%) was highlighted. Common barriers included patient digital literacy (61%), limited healthcare professional experience (46%) and time required per patient (44%). When grouped according to size of insulin pump service, pump starts and renewals in larger services were less impacted by the pandemic compared to smaller services. CONCLUSION: This survey highlights UK healthcare professional experiences of remote care delivery. While supportive of virtual care models, a number of factors highlighted, especially patient digital literacy, need to be addressed to improve virtual care delivery and device training.

Analysis of "Accuracy of a 14-Day Factory Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes".

In this study by Alva et al, accuracy of a second-generation factory calibrated continuous glucose monitoring system is evaluated. Compared to the first-generation FreeStyle Libre 14-day system (FSL), accuracy was improved throughout the 14-day wear period, including improved accuracy in hypoglycemia for adults and youth. The addition of optional real-time alerts for hypoglycemia and hyperglycemia as well as an integrated continuous glucose monitor (iCGM) designation by the FDA may further enable users to benefit from using CGM in real time, including in future automated insulin delivery systems. As CGM accuracy, affordability, and accessibility improve, we anticipate increased uptake of CGM by people on intensive insulin therapy, and also potential benefits and expansion into a broader patient population. There are growing opportunities to leverage cloud-connected CGM devices in the increasingly virtual, continuous telehealth-driven diabetes care model, which will require more focus on development and use of data interoperability standards.

Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.

AIM: To compare accuracy, efficacy and acceptance of implantable and transcutaneous continuous glucose monitoring (CGM) systems. METHODS: In a randomized crossover trial we compared 12 weeks with Eversense implantable sensor (EVS) and 12 weeks with Dexcom G5 transcutaneous sensor (DG5) in terms of accuracy, evaluated as Mean Absolute Relative Difference (MARD) vs capillary glucose (SMBG), time of CGM use, adverse events, efficacy (as HbA1c, time in range, time above and below range) and psychological outcomes evaluated with Diabetes Treatment Satisfaction Questionnaire (DTSQ), Glucose Monitoring Satisfaction Survey (GMSS), Hypoglycemia Fear Survey (HFS2), Diabetes Distress Scale (DDS). RESULTS: 16 subjects (13 males, 48.8 ± 10.1 years, HbA1c 55.8 ± 7.9 mmol/mol, mean ± SD) completed the study. DG5 was used more than EVS [percentage of use 95.7 ± 3.6% vs 93.5 ± 4.3% (p = 0.02)]. MARD was better with EVS (12.2 ± 11.5% vs. 13.1 ± 14.7%, p< 0.001). No differences were found in HbA1c. While using EVS time spent in range increased and time spent in hyperglycemia decreased, but these data were not confirmed by analysis of retrofitted data based on SMBG values. EVS reduced perceived distress, without significant changes in other psychological outcomes. CONCLUSIONS: CGM features may affect glycemic control and device acceptance.

Solution using Stomahesive® wafers for allergic contact dermatitis caused by isobornyl acrylate in glucose monitoring sensors.

Isobornyl acrylate (IBOA) has recently caused a number of cases of allergic contact dermatitis (ACD) from its use in medical devices. We would like to enhance the awareness of this issue with the reporting of three Australian cases, involving two adults and a child. We also report a successful solution by using hydrocolloid wafer (Stomahesive®) as a barrier. As IBOA is not usually found on baseline patch test series and does not cross-react with other acrylic monomers, ACD to IBOA may be missed by clinicians.

Developing and evaluating non-invasive healthcare technologies for a group of female participants from a socioeconomically disadvantaged area.

When compared to the general population, socioeconomically disadvantaged communities frequently experience compromised health. Monitoring the divide is challenging since standardized biomedical tests are linguistically and culturally inappropriate. The aim of this study was to develop and test a unique mobile biomedical testbed based on non-invasive analysis, as well as to explore the relationships between the objective health measures and subjective health outcomes, as evaluated with the World Health Organization Quality of Life survey. The testbed was evaluated in a socioeconomically disadvantaged neighborhood in Malmö, which has been listed as one of the twelve most vulnerable districts in Sweden. The study revealed that compared to conventional protocols the less intrusive biomedical approach was highly appreciated by the participants. Surprisingly, the collected biomedical data illustrated that the apparent health of the participants from the ethnically diverse low-income neighborhood was comparable to the general Swedish population. Statistically significant correlations between perceived health and biomedical data were disclosed, even though the dependences found were complex, and recognition of the manifest complexity needs to be included in further research. Our results validate the potential of non-invasive technologies in combination with advanced statistical analysis, especially when combined with linguistically and culturally appropriate healthcare methodologies, allowing participants to appreciate the significance of the different parameters to evaluate and monitor aspects of health.

Significance of day-to-day glucose variability in patients after acute coronary syndrome.

BACKGROUND: Several studies have recently addressed the importance of glycemic variability (GV) in patients with acute coronary syndrome (ACS). Although daily GV measures, such as mean amplitude of glycemic excursions, are established predictors of poor prognosis in patients with ACS, the clinical significance of day-to-day GV remains to be fully elucidated. We therefore monitored day-to-day GV in patients with ACS to examine its significance. METHODS: In 25 patients with ACS, glucose levels were monitored for 14 days using a flash continuous glucose monitoring system. Mean of daily differences (MODD) was calculated as a marker of day-to-day GV. N-terminal pro-brain natriuretic peptide (NT-proBNP) was evaluated within 4 days after hospitalization. Cardiac function (left ventricular end-diastolic volume, left ventricular ejection fraction, stroke volume) was assessed by echocardiography at 3-5 days after admission and at 10-12 months after the disease onset. RESULTS: Of the 25 patients, 8 (32%) were diagnosed with diabetes, and continuous glucose monitoring (CGM)-based MODD was high (16.6 to 42.3) in 17 patients (68%). Although MODD did not correlate with max creatine kinase (CK), there was a positive correlation between J-index, high blood glucose index, and NT-proBNP (r = 0.83, p < 0.001; r = 0.85, p < 0.001; r = 0.41, p = 0.042, respectively). CONCLUSIONS: In patients with ACS, MODD was associated with elevated NT-proBNP. Future studies should investigate whether day-to-day GV in ACS patients can predict adverse clinical events such as heart failure.

Continuous Glucose Monitoring for the Internist.

Continuous glucose monitoring system is a convenient wearable device that provides glucose readings from the interstitial fluid every few minutes. Continuous glucose monitoring has revolutionized diabetes care. Patients with type 1 diabetes mellitus and type 2 diabetes mellitus, regardless of the type of treatment regimen, can benefit from continuous glucose monitoring. Continuous glucose monitoring systems provide patients with diabetes and their providers with an ambulatory glucose report that summarizes and also gives graphical representations of the glucose data. This wealth of information helps to better understand patients' glycemic patterns, and thereby reduces hemoglobin A1c and hypoglycemia.

Lack of Acceptance of Digital Healthcare in the Medical Market: Addressing Old Problems Raised by Various Clinical Professionals and Developing Possible Solutions.

Various digital healthcare devices and apps, such as blood glucose meters, blood pressure monitors, and step-trackers are commonly used by patients; however, digital healthcare devices have not been widely accepted in the medical market as of yet. Despite the various legal and privacy issues involved in their use, the main reason for its poor acceptance is that users do not use such devices voluntarily and continuously. Digital healthcare devices generally do not provide valuable information to users except for tracking self-checked glucose or walking. To increase the use of these devices, users must first understand the health data produced in the context of their personal health, and the devices must be easy to use and integrated into everyday life. Thus, users need to know how to manage their own data. Medical staff must teach and encourage users to analyze and manage their patient-generated healthcare data, and users should be able to find medical values from these digital devices. Eventually, a single customized service that can comprehensively analyze various medical data to provide valuable customized services to users, and which can be linked to various heterogeneous digital healthcare devices based on the integration of various health data should be developed. Digital healthcare professionals should have detailed knowledge about a variety of digital healthcare devices and fully understand the advantages and disadvantages of digital healthcare to help patients understand and embrace the use of such devices.

Artificial intelligence and diabetes technology: A review.

Artificial intelligence (AI) is widely discussed in the popular literature and is portrayed as impacting many aspects of human life, both in and out of the workplace. The potential for revolutionizing healthcare is significant because of the availability of increasingly powerful computational platforms and methods, along with increasingly informative sources of patient data, both in and out of clinical settings. This review aims to provide a realistic assessment of the potential for AI in understanding and managing diabetes, accounting for the state of the art in the methodology and medical devices that collect data, process data, and act accordingly. Acknowledging that many conflicting definitions of AI have been put forth, this article attempts to characterize the main elements of the field as they relate to diabetes, identifying the main perspectives and methods that can (i) affect basic understanding of the disease, (ii) affect understanding of risk factors (genetic, clinical, and behavioral) of diabetes development, (iii) improve diagnosis, (iv) improve understanding of the arc of disease (progression and personal/societal impact), and finally (v) improve treatment.