A decade of improved glycemic control in young children with type 1 diabetes: A population-based cohort study.

BACKGROUND: Early-onset type 1 diabetes (T1D) is associated with high risk of early cardiovascular complications and premature death. The strongest modifiable risk factor is HbA1c. Other modifiable factors, such as overweight, also increase the risk of complications. During the last decade, the introduction of continuous glucose monitoring (CGM) has offered new options in the treatment of T1D. OBJECTIVE: To compare treatment outcomes in children younger than 7 years with T1D in Sweden in two separate cohorts: one in 2008 and one in 2018. METHODS: All children in the national pediatric diabetes registry (SWEDIABKIDS) younger than 7 years with T1D were included. Data from 2008 and 2018 were analyzed. RESULTS: Data were available on 666 children (45% girls) in 2008 and 779 children (45% girls) in 2018. Mean age was 5.6 (1.4) versus 5.5 (1.4) years and mean diabetes duration 2.3 (1.4) versus 2.2 (1.4) years. The use of CGM increased from 0% to 98% and the use of an insulin pump from 40% in 2008 to 82% (p < 0.01)in 2018.Mean HbA1c was 58 mmol/mol (7.4%) in 2008 and 50 mmol/mol (6.7%) in 2018 (p < 0.01). The frequency of overweight and obesity was the same in 2008 and 2018(26% vs. 29%). CONCLUSION: During this decade, usage of CGM and insulin pump increased and HbA1c decreased. However, HbA1c remained higher than the physiological level and thus continued to represent a cardiovascular risk, especially in combination with overweight or obesity. The frequency of overweight and obesity remained unchanged.

Continuous Glucose Monitoring in the Hospital.

Continuous glucose monitors (CGMs) have suddenly become part of routine care in many hospitals. The coronavirus disease 2019 (COVID-19) pandemic has necessitated the use of new technologies and new processes to care for hospitalized patients, including diabetes patients. The use of CGMs to automatically and remotely supplement or replace assisted monitoring of blood glucose by bedside nurses can decrease: the amount of necessary nursing exposure to COVID-19 patients with diabetes; the amount of time required for obtaining blood glucose measurements, and the amount of personal protective equipment necessary for interacting with patients during the blood glucose testing. The United States Food and Drug Administration (FDA) is now exercising enforcement discretion and not objecting to certain factory-calibrated CGMs being used in a hospital setting, both to facilitate patient care and to obtain performance data that can be used for future regulatory submissions. CGMs can be used in the hospital to decrease the frequency of fingerstick point of care capillary blood glucose testing, decrease hyperglycemic episodes, and decrease hypoglycemic episodes. Most of the research on CGMs in the hospital has focused on their accuracy and only recently outcomes data has been reported. A hospital CGM program requires cooperation of physicians, bedside nurses, diabetes educators, and hospital administrators to appropriately select and manage patients. Processes for collecting, reviewing, storing, and responding to CGM data must be established for such a program to be successful. CGM technology is advancing and we expect that CGMs will be increasingly used in the hospital for patients with diabetes.

'Smart' insulin-delivery technologies and intrinsic glucose-responsive insulin analogues.

Insulin replacement therapy for diabetes mellitus seeks to minimise excursions in blood glucose concentration above or below the therapeutic range (hyper- or hypoglycaemia). To mitigate acute and chronic risks of such excursions, glucose-responsive insulin-delivery technologies have long been sought for clinical application in type 1 and long-standing type 2 diabetes mellitus. Such 'smart' systems or insulin analogues seek to provide hormonal activity proportional to blood glucose levels without external monitoring. This review highlights three broad strategies to co-optimise mean glycaemic control and time in range: (1) coupling of continuous glucose monitoring (CGM) to delivery devices (algorithm-based 'closed-loop' systems); (2) glucose-responsive polymer encapsulation of insulin; and (3) mechanism-based hormone modifications. Innovations span control algorithms for CGM-based insulin-delivery systems, glucose-responsive polymer matrices, bio-inspired design based on insulin's conformational switch mechanism upon insulin receptor engagement, and glucose-responsive modifications of new insulin analogues. In each case, innovations in insulin chemistry and formulation may enhance clinical outcomes. Prospects are discussed for intrinsic glucose-responsive insulin analogues containing a reversible switch (regulating bioavailability or conformation) that can be activated by glucose at high concentrations.

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.

New closed-loop insulin systems.

Advances in diabetes technologies have enabled the development of automated closed-loop insulin delivery systems. Several hybrid closed-loop systems have been commercialised, reflecting rapid transition of this evolving technology from research into clinical practice, where it is gradually transforming the management of type 1 diabetes in children and adults. In this review we consider the supporting evidence in terms of glucose control and quality of life for presently available closed-loop systems and those in development, including dual-hormone closed-loop systems. We also comment on alternative 'do-it-yourself' closed-loop systems. We remark on issues associated with clinical adoption of these approaches, including training provision, and consider limitations of presently available closed-loop systems and areas for future enhancements to further improve outcomes and reduce the burden of diabetes management.

Avances en el tratamiento de la diabetes tipo 1 pediátrica / Advances in the treatment of pediatric type 1 diabetes

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Increased stress, weight gain and less exercise in relation to glycemic control in people with type 1 and type 2 diabetes during the COVID-19 pandemic.

INTRODUCTION: Lockdown measures have a profound effect on many aspects of daily life relevant for diabetes self-management. We assessed whether lockdown measures, in the context of the COVID-19 pandemic, differentially affect perceived stress, body weight, exercise and related this to glycemic control in people with type 1 and type 2 diabetes. RESEARCH DESIGN AND METHODS: We performed a short-term observational cohort study at the Leiden University Medical Center. People with type 1 and type 2 diabetes ≥18 years were eligible to participate. Participants filled out online questionnaires, sent in blood for hemoglobin A1c (HbA1c) analysis and shared data of their flash or continuous glucose sensors. HbA1c during the lockdown was compared with the last known HbA1c before the lockdown. RESULTS: In total, 435 people were included (type 1 diabetes n=280, type 2 diabetes n=155). An increase in perceived stress and anxiety, weight gain and less exercise was observed in both groups. There was improvement in glycemic control in the group with the highest HbA1c tertile (type 1 diabetes: -0.39% (-4.3 mmol/mol) (p<0.0001 and type 2 diabetes: -0.62% (-6.8 mmol/mol) (p=0.0036). Perceived stress was associated with difficulty with glycemic control (p<0.0001). CONCLUSIONS: An increase in perceived stress and anxiety, weight gain and less exercise but no deterioration of glycemic control occurs in both people with relatively well-controlled type 1 and type 2 diabetes during short-term lockdown measures. As perceived stress showed to be associated with glycemic control, this provides opportunities for healthcare professionals to put more emphasis on psychological aspects during diabetes care consultations.

Glycaemic control in the paediatric and young adult population with type 1 diabetes following a single telehealth visit - what have we learned from the COVID-19 lockdown?

AIMS: Children with chronic diseases were unable to receive their usual care during COVID-19 lockdown. We assessed the feasibility and impact of telehealth visits on the time-in-range (TIR) of paediatric individuals with type 1 diabetes (T1D). METHODS: An observational multicentre real-life study. Patients scheduled for an in-clinic visit during the lockdown were offered to participate in a telehealth visit. Sociodemographic, clinical, continuous glucose monitor and pump data were recorded 2 weeks prior and 2 weeks after telehealth visit. The primary endpoint was change in relative-TIR, i.e. change in TIR divided by the percent of possible change (∆TIR/(100-TIRbefore)*100). RESULTS: The study group comprised 195 individuals with T1D (47.7% males), mean±SD age 14.6 ± 5.3 years, and diabetes duration 6.0 ± 4.6 years. Telehealth was accomplished with 121 patients and their parents (62.0%); 74 (38.0%) did not transfer complete data. Mean TIR was significantly higher for the two-week period after the telehealth visit than for the two-week period prior the visit (62.9 ± 16.0, p < 0.001 vs. 59.0 ± 17.2); the improvement in relative-TIR was 5.7±26.1%. Initial higher mean glucose level, lower TIR, less time spent at <54 mg/dl range, longer time spent at 180-250 mg/dl range, higher daily insulin dose, and single-parent household were associated with improved relative-TIR. Multiple regression logistic analysis demonstrated only initial lower TIR and single-parent household were significant, odds ratio: -0.506, (95%CI -0.99,-0.023), p=0.04 and 13.82, (95%CI 0.621, 27.016), p=0.04, respectively. CONCLUSIONS: Paediatric and young adult patients with T1D benefited from a telehealth visit during COVID-19. However, this modality is not yet suitable for a considerable proportion of patients.

A cross sectional study reveals severe disruption in glycemic control in people with diabetes during and after lockdown in India.

BACKGROUND AND AIMS: Uncontrolled diabetes has been associated with poorer clinical outcomes in COVID-19. We aimed to evaluate and assess the impact of COVID-19 pandemic on management of diabetes and challenges faced by people with diabetes in India during and after the lockdown phase. METHODS: A cross-sectional study based on an online questionnaire survey was designed. The questions collected socio-demographic details, medical and social history, and impact of the pandemic on medical and social life from 1582 participants. Linear regression was employed to evaluate association of different parameters with the change in glycemic levels. RESULTS: The frequency of clinical visits during the COVID-19 pandemic were reduced in 87.28% of participants. 92.45% of participants were able to monitor their blood glucose levels (BGLs) in which 78.42% (49.35%, 20.91%, and 8.16%) participants experienced an increase in BGL (mild, moderate, and severe respectively). Only 47.41% of participants possessed the digital glucometer at home. 69.07% of participants reported a decrease in physical activity while 46.88% reported an increase in food intake. 80.06% of participants were able to buy all medicines and 29.80% were gone for virtual consultations while 87.81% reported that they didn't have access to healthcare services. Overall, 89.47% participants experienced disruption in therapy. A highly significant correlation (r = 0.89, p = 0.0145) was found between increasing age and reporting of higher BGLs. CONCLUSION: This study provides a firsthand evidence of major disruption in diabetes care activities during and after the lockdown phase in India and increased risk of poorer clinical outcomes, if infected by SARS-CoV-2.

Flash Continuous Glucose Monitoring in Primary Care Settings: The Need for Measurement of Novel Glycemic Metrics to Adopt Policy and Practice Change.

DISCLOSURES: No outside funding supported the writing of this letter. The author has nothing to disclose.

New technical approach to the diabetes therapy.

Optimal glycemic control remains challenging in individuals with type 1 diabetes. With the comprehensive clinical evidence on safety and efficiency, the adoption of continuous glucose monitoring (CGM), insulin pumps, and control algorithms merging the two into closed-loop systems is rapidly increasing. Particularly the CGM and intermittently scanned CGM improved diabetes management outcomes in large populations. A meaningful translation from clinical trials in highly controlled settings to numerous evaluations of closed-loop technology in the unrestricted home environment ended with its commercialization and use in routine clinical practice. Although it is still not a cure, the closed-loop currently seems to be the most promising advancement in the treatment of diabetes, with promising results also reported from routine clinical practice in children and adults with type 1 diabetes. We summarize different aspects of a technological approach to diabetes care, list currently available devices and systems in the pipeline, and the key supporting clinical evidence for their use. We consider human factors associated with technology use and the importance of health economics to support implementation and reimbursement.

Modern diabetes devices in the school setting: Perspectives from school nurses.

OBJECTIVE: To explore the experiences, practices, and attitudes of school nurses related to modern diabetes devices (insulin pumps, continuous glucose monitors, and hybrid-closed loop systems). RESEARCH DESIGN AND METHODS: Semistructured interviews were conducted with 40 public school nurses caring for children in elementary and middle schools. Developed with stakeholder input, the interview questions explored experiences working with devices and communicating with the health care system. Deidentified transcripts were analyzed through an iterative process of coding to identify major themes. RESULTS: School nurses reported a range of educational backgrounds (58% undergraduate, 42% graduate), geographic settings (20% urban, 55% suburban, 25% rural), and years of experience (20% <5 years, 38%, 5-15 years, 42% >15 years). Four major themes emerged: (a) As devices become more common, school nurses must quickly develop new knowledge and skills yet have inconsistent training opportunities; (b) Enthusiasm for devices is tempered by concerns about implementation due to poor planning prior to the school year and potential disruptions by remote monitors; (c) Barriers exist to integrating devices into schools, including school/classroom policies, liability/privacy concerns, and variable staff engagement; and (d) Collaboration between school nurses and providers is limited; better communication may benefit children with diabetes. CONCLUSIONS: Devices are increasingly used by school-aged children. School nurses appreciate device potential but share structural and individual-level challenges. Guiding policy is needed as the technology progressively becomes standard of care. Enhanced training and collaboration with diabetes providers may help to optimize school-based management for children in the modern era.

Evolution of Diabetes Technology.

Technological innovations have fundamentally changed diabetes care. Insulin pump use and continuous glucose monitoring are associated with improved glycemic control along with a better quality of life; automated insulin-dosing advisors facilitate and improve decision making. Glucose-responsive automated insulin delivery enables the highest targets for time in range, lowest rate and duration of hypoglycemia, and favorable quality of life. Clear targets for time in ranges and a standard visualization of the data will help the diabetes technology to be used more efficiently. Decision support systems within and integrated cloud environment will further simplify, unify, and improve modern routine diabetes care.