INTRODUCTION: Multiple daily injection insulin regimen (MDI) represents the most intensive insulin regimen used in the management of people with type 2 diabetes (PwT2D). Its efficacy regarding glycaemic control is counterbalanced by the increased risk of hypoglycaemia, frequently observed tendency to weight gain and necessity for frequent glucose monitoring. Recent introduction of novel antidiabetic medications with pleiotropic effects reaching far beyond the reduction of glycaemia (HbA1c), such as the glucagon-like peptide 1 receptor agonist (GLP-1 RA), has significantly widened the therapeutic options available for management of T2D. Consequently, there is currently a substantial number of PwT2D for whom the MDI regimen was initiated at a time when no other options were available. Yet, in present times, these individuals could benefit from simplified insulin regimens ideally taking advantage of the beneficial effects of the novel classes of antidiabetic medications. iGlarLixi (Suliqua®) is a once-daily fixed-ratio combination of basal insulin analogue glargine 100 U/ml and a GLP-1 RA lixisenatide. METHODS: Insulin therapy DE-intensificAtion with iglarLixi (IDEAL) is a six-centre, open-label, parallel-group, active comparator, phase IV randomised controlled trial with a 24-week active treatment period examining the efficacy and safety of MDI regimen de-intensification with once-daily administration of iGlarLixi versus MDI regimen continuation in PwT2D on a backgroud therapy with metformin ± sodium-glucose cotransporter 2 inhibitor. PLANNED OUTCOMES: The primary objective is to compare the effects of MDI therapy de-intensification with iGlarLixi versus MDI regimen continuation regarding glycaemic control (HbA1c). Secondary objectives include detailed evaluation of the effects of MDI regimen de-intensification with iGlarLixi on glycaemic control using standardised continuous glucose monitoring (CGM) metrics and self-monitoring of plasma glucose. Furthermore, body weight and body composition analysis, quality of life and safety profile are evaluated. TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT04945070.

• Klíčová slova
• Complex insulin therapy simplification, Fixed-ratio combination of GLP-1 receptor agonist and basal insulin (FRC), Insulin glargine/lixisenatide (iGlarLixi), Insulin therapy de-intensification, Intensified insulin therapy (IIT), Multiple daily injections insulin regimen (MDI), Type 2 diabetes (T2D),
• Publikační typ
• časopisecké články MeSH

People living with diabetes have many medical devices available to assist with disease management. A critical aspect that must be considered is how systems for continuous glucose monitoring and insulin pumps communicate with each other and how the data generated by these devices can be downloaded, integrated, presented and used. Not only is interoperability associated with practical challenges, but also devices must adhere to all aspects of regulatory and legal frameworks. Key issues around interoperability in terms of data ownership, privacy and the limitations of interoperability include where the responsibility/liability for device and data interoperability lies and the need for standard data-sharing protocols to allow the seamless integration of data from different sources. There is a need for standardised protocols for the open and transparent handling of data and secure integration of data into electronic health records. Here, we discuss the current status of interoperability in medical devices and data used in diabetes therapy, as well as regulatory and legal issues surrounding both device and data interoperability, focusing on Europe (including the UK) and the USA. We also discuss a potential future landscape in which a clear and transparent framework for interoperability and data handling also fulfils the needs of people living with diabetes and healthcare professionals.

• Klíčová slova
• Big data, Diabetes therapy, Glucose monitoring, Insulin delivery systems, Interoperability, Medical devices, Review,
• MeSH
• diabetes mellitus * farmakoterapie   MeSH
• elektronické zdravotní záznamy MeSH
• krevní glukóza MeSH
• lidé MeSH
• selfmonitoring glykemie * MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH
• Geografické názvy
• Spojené království MeSH
• Názvy látek
• krevní glukóza MeSH

OBJECTIVE: To compare parameters of glycemic control among three types of hybrid closed loop (HCL) systems in children with T1D (CwD) using population-wide data from the national pediatric diabetes registry ČENDA. METHODS: CwD aged <19 years treated with Medtronic MiniMed 780G (780G), Tandem t:slim X2 (Control-IQ) or do-it-yourself AndroidAPS (AAPS) systems for >12 months and monitored by CGM >70% of the time were included. HbA1c, times in glycemic ranges, and Glycemia Risk Index (GRI) were used for cross-sectional comparison between the HCL systems. RESULTS: Data from 512 CwD were analyzed. 780G, Control-IQ and AAPS were used by 217 (42.4%), 211 (41.2%), and 84 (16.4%) CwD, respectively. The lowest HbA1c value was observed in the AAPS group (44 mmol/mol; IQR 8.0, p<0.0001 vs any other group), followed by Control-IQ and 780G groups (48 (IQR 11) and 52 (IQR 10) mmol/mol, respectively). All of the systems met the recommended criteria for time in range (78% in AAPS, 76% in 780G, and 75% in Control-IQ users). CwD using AAPS spent significantly more time in hypoglycemia (5% vs 2% in 780G and 3% in Control-IQ) and scored the highest GRI (32, IQR 17). The lowest GRI (27, IQR 15) was seen in 780G users. CONCLUSION: Although all HCL systems proved effective in maintaining recommended long-term glycemic control, we observed differences that illustrate strengths and weaknesses of particular systems. Our findings could help in individualizing the choice of HCL systems.

• Klíčová slova
• AndroidAPS, hybrid closed loop, pediatrics, registry, type 1 diabetes,
• MeSH
• diabetes mellitus 1. typu * farmakoterapie   MeSH
• dítě MeSH
• glykovaný hemoglobin MeSH
• hypoglykemie * chemicky indukované   epidemiologie   MeSH
• inzulin terapeutické užití   MeSH
• inzulinové infuzní systémy MeSH
• krevní glukóza MeSH
• lidé MeSH
• průřezové studie MeSH
• registrace MeSH
• selfmonitoring glykemie MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• Názvy látek
• glykovaný hemoglobin MeSH
• inzulin MeSH
• krevní glukóza MeSH

INTRODUCTION: Frequent scanning of FreeStyle Libre (FSL) flash glucose monitoring sensors is known to be important whilst wearing an active sensor, but adherence to sensor reapplication is also critical to effective glucose monitoring. We report novel measures of adherence for users of the FSL system and their association with improvements in metrics of glucose control. METHODS: Anonymous data were extracted for 1600 FSL users in the Czech Republic with ≥ 36 completed sensors from October 22, 2018 to December 31, 2021. "Experience" was defined by the number of sensors used (1-36 sensors). "Adherence" was defined by time between the end of one sensor and the start of the next (gap time). User adherence was analyzed for four experience levels after initiating FLASH; Start (sensors 1-3); Early (sensors 4-6); Middle (sensors 19-21); End (sensors 34-36). Users were split into two adherence levels based on mean gap time during Start period, "low" (> 24 h, n = 723) and "high" (≤ 8 h, n = 877). RESULTS: Low-adherence users reduced their sensor gap times significantly: 38.5% applied a new sensor within 24 h during sensors 4-6, rising to 65.0% by sensors 34-36 (p < 0.001). Improved adherence was associated with increased %TIR (time in range; mean + 2.4%; p < 0.001), reduced %TAR (time above range; mean - 3.1%; p < 0.001), and reduced glucose coefficient of variation (CV; mean - 1.7%; p < 0.001). CONCLUSIONS: With experience, FSL users became more adherent in sensor reapplication, with associated increases in %TIR, and reductions in %TAR and glucose variability.

• Klíčová slova
• Behavioral change, Continuous glucose monitoring, Czech Republic, Flash glucose monitoring, Hyperglycemia, Hypoglycemia, Real-world data, Time in range,
• Publikační typ
• časopisecké články MeSH

The 8th Cardiovascular Outcome Trial (CVOT) Summit on Cardiovascular, Kidney, and Glycemic Outcomes was held virtually on November 10-12, 2022. Following the tradition of previous summits, this reference congress served as a platform for in-depth discussion and exchange on recently completed outcomes trials as well as key trials important to the cardiovascular (CV) field. This year's focus was on the results of the DELIVER, EMPA-KIDNEY and SURMOUNT-1 trials and their implications for the treatment of heart failure (HF) and chronic kidney disease (CKD) with sodium-glucose cotransporter-2 (SGLT2) inhibitors and obesity with glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists. A broad audience of primary care physicians, diabetologists, endocrinologists, cardiologists, and nephrologists participated online in discussions on new consensus recommendations and guideline updates on type 2 diabetes (T2D) and CKD management, overcoming clinical inertia, glycemic markers, continuous glucose monitoring (CGM), novel insulin preparations, combination therapy, and reclassification of T2D. The impact of cardiovascular outcomes on the design of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) trials, as well as the impact of real-world evidence (RWE) studies on the confirmation of CVOT outcomes and clinical trial design, were also intensively discussed. The 9th Cardiovascular Outcome Trial Summit will be held virtually on November 23-24, 2023 ( http://www.cvot.org ).

• Klíčová slova
• Cardiovascular disease, Chronic kidney disease, Diabetes, GIP/GLP-1 receptor agonist, Heart failure, Obesity, SGLT2 inhibitor,
• MeSH
• chronická renální insuficience * diagnóza   farmakoterapie   epidemiologie   MeSH
• diabetes mellitus 2. typu * diagnóza   farmakoterapie   epidemiologie   MeSH
• hypoglykemika terapeutické užití   MeSH
• kardiovaskulární nemoci * diagnóza   farmakoterapie   epidemiologie   MeSH
• krevní glukóza MeSH
• ledviny MeSH
• lidé MeSH
• receptor pro glukagonu podobný peptid 1 agonisté   MeSH
• selfmonitoring glykemie MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• dopisy MeSH
• Názvy látek
• hypoglykemika MeSH
• krevní glukóza MeSH
• receptor pro glukagonu podobný peptid 1 MeSH

In this paper, we propose an innovative Federated Learning-inspired evolutionary framework. Its main novelty is that this is the first time that an Evolutionary Algorithm is employed on its own to directly perform Federated Learning activity. A further novelty resides in the fact that, differently from the other Federated Learning frameworks in the literature, ours can efficiently deal at the same time with two relevant issues in Machine Learning, i.e., data privacy and interpretability of the solutions. Our framework consists of a master/slave approach in which each slave contains local data, protecting sensible private data, and exploits an evolutionary algorithm to generate prediction models. The master shares through the slaves the locally learned models that emerge on each slave. Sharing these local models results in global models. Being that data privacy and interpretability are very significant in the medical domain, the algorithm is tested to forecast future glucose values for diabetic patients by exploiting a Grammatical Evolution algorithm. The effectiveness of this knowledge-sharing process is assessed experimentally by comparing the proposed framework with another where no exchange of local models occurs. The results show that the performance of the proposed approach is better and demonstrate the validity of its sharing process for the emergence of local models for personal diabetes management, usable as efficient global models. When further subjects not involved in the learning process are considered, the models discovered by our framework show higher generalization capability than those achieved without knowledge sharing: the improvement provided by knowledge sharing is equal to about 3.03% for precision, 1.56% for recall, 3.17% for F1, and 1.56% for accuracy. Moreover, statistical analysis reveals the statistical superiority of model exchange with respect to the case of no exchange taking place.

• Klíčová slova
• diabetes, evolutionary algorithms, federated learning, interpretable machine learning,
• MeSH
• algoritmy * MeSH
• glukosa MeSH
• lidé MeSH
• soukromí MeSH
• strojové učení * MeSH
• znalosti MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• glukosa MeSH

AIMS: Residual beta cell function in type 1 diabetes (T1D) is associated with lower risk of complications. Autoantigen therapy with GAD-alum (Diamyd) given in 3 intralymphatic injections with oral vitamin D has shown promising results in persons with T1D carrying the human leukocyte antigen (HLA) DR3-DQ2 haplotype in the phase 2b trial DIAGNODE-2. We aimed to explore the efficacy of intralymphatic GAD-alum on blood glucose recorded by continuous glucose monitoring (CGM). METHODS: DIAGNODE-2 (NCT03345004) was a multicenter, randomized, placebo-controlled, double-blind trial of 109 recent-onset T1D patients aged 12 to 24 years with GAD65 antibodies and fasting C-peptide > 0.12 nmol/L, which randomized patients to 3 intralymphatic injections of 4 μg GAD-alum and oral vitamin D, or placebo. We report results for exploratory endpoints assessed by 14-day CGM at months 0, 6, and 15. Treatment arms were compared by mixed-effects models for repeated measures adjusting for baseline values. RESULTS: We included 98 patients with CGM recordings of sufficient quality (DR3-DQ2-positive patients: 27 GAD-alum-treated and 15 placebo-treated). In DR3-DQ2-positive patients, percent of time in range (TIR, 3.9-10 mmol/L) declined less between baseline and month 15 in GAD-alum-treated compared with placebo-treated patients (-5.1% and -16.7%, respectively; P = 0.0075), with reduced time > 13.9 mmol/L (P = 0.0036), and significant benefits on the glucose management indicator (P = 0.0025). No differences were detected for hypoglycemia. GAD-alum compared to placebo lowered the increase in glycemic variability (standard deviation) observed in both groups (P = 0.0219). Change in C-peptide was correlated with the change in TIR. CONCLUSIONS: Intralymphatic GAD-alum improves glycemic control in recently diagnosed T1D patients carrying HLA DR3-DQ2.

• Klíčová slova
• C-peptide, Diamyd, GAD-alum, GAD65, HLA DR3-DQ2, HbA1c, antigen-specific immune therapy, continuous glucose monitoring, type 1 diabetes,
• MeSH
• C-peptid MeSH
• diabetes mellitus 1. typu * MeSH
• dítě MeSH
• glutamát dekarboxyláza MeSH
• HLA-DR3 antigen MeSH
• kamencové sloučeniny MeSH
• krevní glukóza MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• regulace glykemie MeSH
• selfmonitoring glykemie MeSH
• vitamin D terapeutické užití   MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• aluminum sulfate MeSH Prohlížeč
• C-peptid MeSH
• glutamát dekarboxyláza MeSH
• HLA-DR3 antigen MeSH
• kamencové sloučeniny MeSH
• krevní glukóza MeSH
• vitamin D MeSH

Open-source automated insulin delivery systems, commonly referred to as do-it-yourself automated insulin delivery systems, are examples of user-driven innovations that were co-created and supported by an online community who were directly affected by diabetes. Their uptake continues to increase globally, with current estimates suggesting several thousand active users worldwide. Real-world user-driven evidence is growing and provides insights into safety and effectiveness of these systems. The aim of this consensus statement is two-fold. Firstly, it provides a review of the current evidence, description of the technologies, and discusses the ethics and legal considerations for these systems from an international perspective. Secondly, it provides a much-needed international health-care consensus supporting the implementation of open-source systems in clinical settings, with detailed clinical guidance. This consensus also provides important recommendations for key stakeholders that are involved in diabetes technologies, including developers, regulators, and industry, and provides medico-legal and ethical support for patient-driven, open-source innovations.

• MeSH
• diabetes mellitus 1. typu * farmakoterapie   MeSH
• hypoglykemika terapeutické užití   MeSH
• inzulin * terapeutické užití   MeSH
• inzulinové infuzní systémy MeSH
• lidé MeSH
• zdravotnický personál MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Research Support, N.I.H., Extramural MeSH
• Názvy látek
• hypoglykemika MeSH
• inzulin * MeSH

AIMS/HYPOTHESIS: The proportion of children with type 1 diabetes (T1D) who have experience with low-carbohydrate diet (LCD) is unknown. Our goal was to map the frequency of LCD among children with T1D and to describe their clinical and laboratory data. METHODS: Caregivers of 1040 children with T1D from three centers were addressed with a structured questionnaire regarding the children's carbohydrate intake and experience with LCD (daily energy intake from carbohydrates below 26% of age-recommended values). The subjects currently on LCD were compared to a group of non-LCD respondents matched to age, T1D duration, sex, type and center of treatment. RESULTS: A total of 624/1040 (60%) of the subjects completed the survey. A total of 242/624 (39%) subjects reported experience with voluntary carbohydrate restriction with 36/624 (5.8%) subjects currently following the LCD. The LCD group had similar HbA1c (45 vs. 49.5, p = 0.11), lower average glycemia (7.0 vs. 7.9, p = 0.02), higher time in range (74 vs. 67%, p = 0.02), lower time in hyperglycemia >10 mmol/L (17 vs. 20%, p = 0.04), tendency to more time in hypoglycemia <3.9 mmol/L(8 vs. 5%, p = 0.05) and lower systolic blood pressure percentile (43 vs. 74, p = 0.03). The groups did not differ in their lipid profile nor in current body height, weight or BMI. The LCD was mostly initiated by the parents or the subjects themselves and only 39% of the families consulted their decision with the diabetologist. CONCLUSIONS/INTERPRETATION: Low carbohydrate diet is not scarce in children with T1D and is associated with modestly better disease control. At the same time, caution should be applied as it showed a tendency toward more frequent hypoglycemia.

• Klíčová slova
• low-carbohydrate diet, time in range, type 1 diabetes,
• MeSH
• diabetes mellitus 1. typu dietoterapie   metabolismus   MeSH
• dieta s omezením sacharidů * škodlivé účinky   statistika a číselné údaje   MeSH
• dítě MeSH
• glykovaný hemoglobin analýza   MeSH
• index tělesné hmotnosti MeSH
• krevní glukóza analýza   MeSH
• lidé MeSH
• lipidy krev   MeSH
• průzkumy a dotazníky MeSH
• tělesná hmotnost MeSH
• tělesná výška MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• Názvy látek
• glykovaný hemoglobin MeSH
• krevní glukóza MeSH
• lipidy MeSH

OBJECTIVE: The aim of this trial was to compare the efficacy of real-time and intermittently scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control. RESEARCH DESIGN AND METHODS: In this randomized study, adults with type 1 diabetes (T1D) and normal hypoglycemia awareness (Gold score <4) used rtCGM (Guardian Connect Mobile) or isCGM (FreeStyle Libre) during 4 days of physical activity (exercise phase) and in the subsequent 4 weeks at home (home phase). Primary end points were time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) and time in range (3.9-10.0 mmol/L [70-180 mg/dL]). The isCGM group wore an additional masked Enlite sensor (iPro2) for 6 days to check for bias between the different sensors used by the rtCGM and isCGM systems. RESULTS: Sixty adults with T1D (mean age 38 ± 13 years; A1C 62 ± 12 mmol/mol [7.8 ± 1.1%]) were randomized to rtCGM (n = 30) or isCGM (n = 30). All participants completed the study. Percentage of time in hypoglycemia (<3.9 mmol/L [<70 mg/dL]) was lower among rtCGM versus isCGM participants in the exercise phase (6.8 ± 5.5% vs. 11.4 ± 8.6%, respectively; P = 0.018) and during the home phase (5.3 ± 2.5% vs. 7.3 ± 4.4%, respectively; P = 0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range (3.9-10 mmol/L [70-180 mg/dL]) than isCGM participants throughout both the exercise (78.5 ± 10.2% vs. 69.7 ± 16%, respectively; P = 0.0149) and home (75.6 ± 9.7% vs. 67.4 ± 17.8%, respectively; P = 0.0339) phases. The results were robust to the insignificant bias between rtCGM and isCGM sensors that masked CGM found in the isCGM arm. CONCLUSIONS: rtCGM was superior to isCGM in reducing hypoglycemia and improving time in range in adults with T1D with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.

• MeSH
• cvičení fyziologie   MeSH
• diabetes mellitus 1. typu krev   farmakoterapie   MeSH
• dospělí MeSH
• glykovaný hemoglobin analýza   účinky léků   metabolismus   MeSH
• hypoglykemie krev   chemicky indukované   MeSH
• hypoglykemika terapeutické užití   MeSH
• krevní glukóza analýza   účinky léků   metabolismus   MeSH
• lidé středního věku MeSH
• lidé MeSH
• počítače do ruky MeSH
• počítačové systémy MeSH
• regulace glykemie přístrojové vybavení   metody   MeSH
• selfmonitoring glykemie metody   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• glykovaný hemoglobin MeSH
• hypoglykemika MeSH
• krevní glukóza MeSH