[Erratum in "Point-of-Care Blood Glucose Testing: Post-Market Performance Assessment of the Accu-Chek Inform II Hospital-Use Glucose Meter" (DOI: 10.26442/00403660.2023.12.202522)].

In the article "Point-of-care blood glucose testing: post-market performance assessment of the Accu-Chek Inform II hospital-use glucose meter," published in the Terapevticheskii Arkhiv journal, Vol. 95, No.12, 2023 (DOI: 10.26442/00403660.2023.12.202522), errors were made: the term "measurements at the place of treatment" was changed, as well as the section "Conflict of interest." At the request of the authors' team, errors in the conflict of interest and the wording of the term have been corrected, and the section "Information about the authors" has been updated. The publisher replaced the original version of the published article with the corrected one; the information on the website was also corrected. Correct text of the section "Conflict of interest": Conflict of interest. All authors are not employees or consultants of Roche Diagnostics and have not received any compensation from Roche Diagnostics. Correct wording of the term in Russian: "измерения по месту лечения". Changes were made to the title of the article in Russian: "Измерения глюкозы по месту лечения: пострегистрационное испытание госпитального глюкометра Акку-Чек Информ II", the text of the abstract, keywords, citation, in the text of the article, and abbreviations. Information of the place of work has been updated: Center for Laboratory Diagnostics of the Russian Children Clinical Hospital, a Branch of the Pirogov Russian National Research Medical University. The publisher apologizes to readers and authors for the errors and is confident that the correction of errors will ensure the correct perception and interpretation of the results of the study described in the text.

Implementation research: a protocol for two three-arm pragmatic randomised controlled trials on continuous glucose monitoring devices in people with type 1 diabetes in South Africa and Kenya.

BACKGROUND: Self-monitoring of glucose is an essential component of type 1 diabetes (T1D) management. In recent years, continuous glucose monitoring (CGM) has provided an alternative to daily fingerstick testing for the optimisation of insulin dosing and general glucose management in people with T1D. While studies have been conducted to evaluate the impact of CGM on clinical outcomes in the US, Europe and Australia, there are limited data available for low- and middle-income countries (LMICs) and further empirical evidence is needed to inform policy decision around their use in these countries. METHODS: This trial was designed as a pragmatic, parallel-group, open-label, multicentre, three-arm, randomised (1:1:1) controlled trial of continuous or periodic CGM device use versus standard of care in people with T1D in South Africa and Kenya. The primary objective of this trial will be to assess the impact of continuous or periodic CGM device use on glycaemic control as measured by change from baseline glycosylated haemoglobin (HbA1c). Additional assessments will include clinical outcomes (glucose variation, time in/below/above range), safety (adverse events, hospitalisations), quality of life (EQ-5D, T1D distress score, Glucose Monitoring Satisfaction Survey for T1D), and health economic measures (incremental cost-effectiveness ratios, quality adjusted life years). DISCUSSION: This trial aims to address the substantial evidence gap on the impact of CGM device use on clinical outcomes in LMICs, specifically South Africa and Kenya. The trial results will provide evidence to inform policy and treatment decisions in these countries. TRIAL REGISTRATION: NCT05944731 (Kenya), July 6, 2023; NCT05944718 (South Africa), July 13, 2023.

Practical considerations for continuous glucose monitoring in elite athletes with type 1 diabetes mellitus: A narrative review.

Type 1 diabetes mellitus (T1DM) refers to a metabolic condition where a lack of insulin impairs the usual homeostatic mechanisms to control blood glucose levels. Historically, participation in competitive sport has posed a challenge for those with T1DM, where the dynamic changes in blood glucose during exercise can result in dangerously high (hyperglycaemia) or low blood glucoses (hypoglycaemia) levels. Over the last decade, research and technological development has enhanced the methods of monitoring and managing blood glucose levels, thus reducing the chances of experiencing hyper- or hypoglycaemia during exercise. The introduction of continuous glucose monitoring (CGM) systems means that glucose can be monitored conveniently, without the need for frequent fingerpick glucose checks. CGM devices include a fine sensor inserted under the skin, measuring levels of glucose in the interstitial fluid. Readings can be synchronized to a reader or mobile phone app as often as every 1-5 min. Use of CGM devices is associated with lower HbA1c and a reduction in hypoglycaemic events, promoting overall health and athletic performance. However, there are limitations to CGM, which must be considered when being used by an athlete with T1DM. These limitations can be addressed by individualized education plans, using protective equipment to prevent sensor dislodgement, as well as further research aiming to: (i) account for disparities between CGM and true blood glucose levels during vigorous exercise; (ii) investigate the effects of temperature and altitude on CGM accuracy, and (iii) explore of the sociological impact of CGM use amongst sportspeople without diabetes on those with T1DM.

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.

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.

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.

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.

Improved individual and population-level HbA1c estimation using CGM data and patient characteristics.

Machine learning and linear regression models using CGM and participant data reduced HbA1c estimation error by up to 26% compared to the GMI formula, and exhibit superior performance in estimating the median of HbA1c at the cohort level, potentially of value for remote clinical trials interrupted by COVID-19.

Transforming type 1 diabetes: the next wave of innovation.

The discovery of insulin in 1921 enabled pharmaceutical production of animal insulins for the treatment of people with type 1 diabetes by 1922. The last several decades have witnessed enormous scientific progress in the therapy of type 1 diabetes, yet some developments have been incremental, and insulin is not a cure. Herein, I highlight key scientific advances potentially poised to improve the quality of life and treatment outcomes in type 1 diabetes. These innovations range from newer insulin analogues to the development of smart insulins, oral and weekly insulins, glucose sensors and closed-loop insulin-delivery devices, as well as strategies for durable human beta cell replacement coupled with selective immune manipulation to preserve beta cell function. Finally, progress in the prediction and prevention of type 1 diabetes highlights the ongoing challenges and potential for altering the natural history of the disease or eliminating type 1 diabetes altogether.

Continuous glucose monitoring: A review of the evidence in type 1 and 2 diabetes mellitus.

CONTEXT AND AIM: Continuous glucose monitoring (CGM) is becoming widely accepted as an adjunct to diabetes management. Compared to standard care, CGM can provide detailed information about glycaemic variability in an internationally standardised ambulatory glucose profile, enabling more informed user and clinician decision making. We aimed to review the evidence, user experience and cost-effectiveness of CGM. METHODS: A literature search was conducted by combining subject headings 'CGM' and 'flash glucose monitoring', with key words 'type 1 diabetes' and 'type 2 diabetes', limited to '1999 to current'. Further evidence was obtained from relevant references of retrieved articles. RESULTS: There is a strong evidence for CGM use in people with type 1 diabetes, with benefits of reduced glycated haemoglobin and hypoglycaemia, and increased time in range. While the evidence for CGM use in type 2 diabetes is less robust, similar benefits have been demonstrated. CGM can improve diabetes-related satisfaction in people with diabetes (PWD) and parents of children with diabetes, as well as the clinician experience. However, CGM does have limitations including cost, accuracy and perceived inconvenience. Cost-effectiveness analyses have indicated that CGM is a cost-effective adjunct to type 1 diabetes management that is associated with reduced diabetes-related complications and hospitalisation. CONCLUSIONS: Continuous glucose monitoring is revolutionising diabetes management. It is a cost-effective adjunct to diabetes management that has the potential to improve glycaemic outcomes and quality of life in PWD, especially type 1 diabetes.

The effects of continuous glucose monitoring system on patient outcomes and associated costs in a real-world setting.

AIMS: Continuous glucose monitoring system (CGMS) technologies may alert unaware hypoglycaemia or near hypoglycaemia events. However, costs are a significant concern in general CGMS use. This study describes the real-world effects of both clinical outcomes and associated costs in a major Health Maintenance Organization, 1 year following preauthorization of CGMS for each patient. METHODS: Cohort study. Type 1 diabetes patients who were preauthorized CGMS were identified, and their medical records during the year before preauthorization were compared to the following year. Data were collected for glucose control, medical services utilization and related costs. RESULTS: We identified 524 eligible patients, 57% males. Adherence to CGMS use was improved by age. The proportion of patients reaching HbA1c  < 7.5% (58 mmol/mol) increased in the high-adherence group and decreased in the low-adherence group. There were no significant changes in outpatient medical services utilization. However, there was a decrease in emergency room visit rates (30%-19%, p < 0.01) and hospitalization rates (22%-12%, p < 0.01) with the highest decrease among the high-adherence group. Hospitalization duration also decreased. However, the total costs per patient were higher as CGMS adherence increased. CONCLUSION: Continuous glucose monitoring system technologies have the potential of both improving blood glucose control and reducing inpatient utilization. However, CGMS technologies costs may put a significant burden on healthcare systems.

Assessment of the accuracy of an intermittent-scanning continuous glucose monitoring device in patients with type 2 diabetes mellitus undergoing hemodialysis (AIDT2H) study.

FreeStyle Libre has been approved for use in patients undergoing hemodialysis (HD) in Japan, unlike Europe and the United States; however, evidence regarding its accuracy in such patients is sparse. Forty-one participants with type 2 diabetes undergoing HD were recruited. The overall mean absolute relative difference and mean absolute difference were 23.4% and 33.9 mg/dL, respectively. Sensor glucose levels and capillary glucose levels were significantly correlated (r = 0.858, P < .01), although the sensor glucose levels were significantly lower than the capillary glucose levels. The accuracy of FreeStyle Libre in patients undergoing HD became deteriorated with the days of usage. The percentage of sensor results in Zones A and B in the consensus error grid analysis and in the Clarke error grid analysis were 99.7% and 99.0%, respectively. Its insufficient accuracy necessitates adjunct usage of FreeStyle Libre with self-monitoring of blood glucose in patients undergoing HD.

Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials.

AIMS: Self-monitoring of blood glucose (SMBG) represented a major breakthrough in the treatment of type 1 diabetes. The aim of the present meta-analysis is to assess the effect of continues glucose monitoring (CGM) and flash glucose monitoring (FGM), on glycemic control in type 1 diabetes. MATERIALS AND METHODS: The present analysis includes randomized clinical trials comparing CGM or FGM with SMBG, with a duration of at least 12 weeks, identified in Medline or clinicaltrials.gov. The principal endpoint was HbA1c at the end of the trial. A secondary endpoint was severe hypoglycemia. Mean and 95% confidence intervals for HbA1c and Mantel-Haenzel odds ratio [MH-OR] for severe hypoglycemia were calculated, using random effect models. A sensitivity analysis was performed using fixed effect models. In addition, the following secondary endpoints were explored, using the same methods: time in range, health-related quality of life, and treatment satisfaction. Separate analyses were performed for trials comparing CGM with SMBG, and those comparing CGM + CSII and SMBG + MDI and CGM-regulated insulin infusion system (CRIS) and CSII + SMBG. RESULTS: CGM was associated with a significantly lower HbA1c at endpoint in comparison with SMBG (- 0.24 [- 0.34, - 0.13]%); CGM was associated with a significantly lower risk of severe hypoglycemia than SMBG. Treatment satisfaction and quality of life were not measured, or not reported, in the majority of studies. FGM showed a significant reduction in the incidence of mild hypoglycemia and an increased treatment satisfaction, but no significant results are shown in HbA1c. CGM + CSII in comparison with SMBG + MDI was associated with a significant reduction in HbA1c. Only two trials with a duration of at least 12 weeks compared a CRIS with SMBG + CSII; HbA1c between the two treatment arms was not statistically significant (difference in means: - 0.23 [- 0.91; 0.46]%; p = 0.52). CONCLUSION: GCM compared to SMBG has showed a reduction in HbA1c and severe hypoglycemia in patient with type 1 diabetes. The comparison between CGM + CSII and SMBG + MDI showed a large reduction in HbA1c; it is conceivable that the effects of CSII + CGM on glycemic control additives. The only comparison available between FGM and SMBG was conducted in patients in good control.

The Digital/Virtual Diabetes Clinic: The Future Is Now-Recommendations from an International Panel on Diabetes Digital Technologies Introduction.

The increasing prevalence of diabetes, combined with a growing global shortage of health care professionals (HCP), necessitates the need to develop new approaches to diabetes care delivery to expand access to care, lessen the burden on people with diabetes, improve efficiencies, and reduce the unsustainable financial liability on health systems and payers. Use of digital diabetes technologies and telehealth protocols within a digital/virtual diabetes clinic has the potential to address these challenges. However, several issues must be resolved to move forward. In February 2020, organizers of the Advanced Technologies & Treatments for Diabetes Annual Conference convened an international panel of HCP, researchers, patient advocates, and industry representatives to review the status of digital diabetes technologies, characterize deficits in current technologies, and identify issues for consideration. Since that meeting, the importance of using telehealth and digital diabetes technologies has been demonstrated amid the global coronavirus disease (COVID-19) pandemic. This article summarizes the panel's discussion of the opportunities, obstacles, and requisites for advancing the use of these technologies as a standard of care for the management of diabetes.

Impact of COVID-19 lockdown on flash and real-time glucose sensor users with type 1 diabetes in England.

AIMS: People with type 1 diabetes (T1D) face the daily task of implementing self-management strategies to achieve their glycaemic goals. The UK COVID-19 lockdown has had an impact on day-to-day behaviour, which may affect diabetes self-management and outcomes. We assessed whether sensor-based outcomes pre- and during lockdown periods were different in a cohort of glucose sensor users with T1D. METHODS: Data were collected from Freestyle Libre (FSL) or Dexcom G6 sensor users who remotely shared their data with the diabetes clinic web platform. Sensor metrics according to international consensus were analysed and compared between pre-lockdown period and 2 and 3 weeks into lockdown (periods 1 and 2). RESULTS: Two hundred and sixty-nine T1D patients (baseline HbA1c 57 ± 14 mmol/mol) were identified as FSL (n = 190) or Dexcom G6 (n = 79) users. In patients with sensor use > 70% (N = 223), compared to pre-lockdown period percentage TIR 3.9-10 mM (TIR) significantly increased during period 1 (59.6 ± 18.2 vs. 57.5 ± 17.2%, p = 0.002) and period 2 (59.3 ± 18.3 vs. 57.5 ± 17.2%, p = 0.035). The proportion of patients achieving TIR ≥ 70% increased from 23.3% pre-lockdown to 27.8% in period 1 and 30.5% in period 2. A higher proportion also achieved the recommended time below and above range, and coefficient of variation in periods 1 and 2. Dexcom G6 users had significantly lower % time below range (< 3.9 mM) compared to FSL users during both lockdown periods (period 1: Dexcom G6 vs. FSL: 1.8% vs. 4%; period 2: 1.4% vs. 4%, p < 0.005 for both periods). CONCLUSION: Sensor-based glycaemic outcomes in people with T1D in the current cohort improved during COVID-19 lockdown, which may be associated with positive changes in self-management strategies. Further work is required to evaluate long-term sustainability and support.