BACKGROUND: Effective diabetes management requires a multimodal approach involving lifestyle changes, pharmacological treatment, and continuous patient education. Self-management demands can be overwhelming for patients, leading to lowered motivation, poor adherence, and compromised therapeutic outcomes. In this context, digital health apps are emerging as vital tools to provide personalized support and enhance diabetes management and clinical outcomes. OBJECTIVE: This study evaluated the impact of the digital health application Vitadio on glycemic control in patients with type 2 diabetes mellitus (T2DM). Secondary objectives included evaluating its effects on cardiometabolic parameters (weight, BMI, waist circumference, blood pressure, and heart rate) and self-reported measures of diabetes distress and self-management. METHODS: In this 6-month, 2-arm, multicenter, unblinded randomized controlled trial, patients aged 18 years or older diagnosed with T2DM were randomly assigned (1:1) to an intervention group (IG) receiving standard diabetes care reinforced by the digital health app Vitadio or to a control group (CG) provided solely with standard diabetes care. Vitadio provided a mobile-based self-management support tool featuring educational modules, motivational messages, peer support, personalized goal setting, and health monitoring. The personal consultant was available in the app to provide technical support for app-related issues. The primary outcome, assessed in the intention-to-treat population, was a change in glycated hemoglobin (HbA1c) levels at 6 months. Secondary outcomes included changes in cardiometabolic measures and self-reported outcomes. Data were collected in 2 study centers: diabetologist practice in Dessau-Roßlau and the University of Dresden. RESULTS: Between November 2022 and June 2023, a total of 276 patients were screened for eligibility, with 149 randomized to in intervention group (IG; n=73) and a control group (CG; n=76). The majority of participants were male (91/149, 61%). The dropout rate at month 6 was 19% (121/149). While both groups achieved significant HbA1c reduction at 6 months (IG: mean -0.8, SD 0.9%, P<.001; CG: mean -0.3, SD 0.7%, P=.001), the primary confirmatory analysis revealed statistically significant advantage of the IG (adjusted mean difference: -0.53%, SD 0.15, 95% CI -0.24 to -0.82; P<.001; effect size [Cohen d]=0.67, 95% CI 0.33-1). Significant between-group differences in favor of the IG were also observed for weight loss (P=.002), BMI (P=.001) and systolic blood pressure (P<.03). In addition, Vitadio users experienced greater reduction in diabetes-related distress (P<.03) and obtained more pronounced improvements in self-care practices in the areas of general diet (P<.001), specific diet (P<.03), and exercise (P<.03). CONCLUSIONS: This trial provides evidence for the superior efficacy of Vitadio in lowering the HbA1c levels in T2DM patients compared to standard care. In addition, Vitadio contributed to improvements in cardiometabolic health, reduced diabetes-related distress, and enhanced self-management, highlighting its potential as an accessible digital tool for comprehensive diabetes management. TRIAL REGISTRATION: German Clinical Trials Registry DRKS00027405; https://drks.de/search/de/trial/DRKS00027405.

• Klíčová slova
• DiGA, digital health, digital therapeutics, mHealth, type 2 diabetes mellitus,
• MeSH
• diabetes mellitus 2. typu * krev   terapie   MeSH
• dospělí MeSH
• glykovaný hemoglobin analýza   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mobilní aplikace * MeSH
• péče o sebe MeSH
• self-management MeSH
• senioři MeSH
• telemedicína MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• glykovaný hemoglobin MeSH

AIMS: To assess the efficacy and safety of switching from premixed insulin to a once-daily, fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide (iGlarLixi) in people with type 2 diabetes (T2D). METHODS: In this phase 4, 24-week, single-arm study, participants switched from once-daily or twice-daily premixed insulin to iGlarLixi (EudraCT number 2021-003711-25). Key inclusion criteria: ≥18 years; premixed insulin therapy for ≥3 months and < 10 years; ± 1-2 oral antidiabetic drugs (OADs); HbA1c ≥7.5% to ≤10.0%. The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included: participants achieving HbA1c <7% and change in body weight at Week 24, and safety. RESULTS: Overall, 162 participants switched to iGlarLixi (89.5% from twice-daily premixed insulin); mean duration of diabetes was 15.7 (standard deviation [SD]: 8.3) years. Mean baseline HbA1c (8.5%) reduced by least squares (LS) mean of 1.2% (95% confidence interval [CI]: -1.4, -1.1) at Week 24, and 37.6% of participants had achieved an HbA1c target of <7% (95% CI: 30.0, 45.7). LS mean body weight change from baseline to Week 24 was -1.0 kg (95% CI: -1.6, -0.5). Fasting and post-prandial plasma glucose decreased from baseline to Week 24 by 45.6 mg/dL (SD ± 52.4) and 67.6 mg/dL (SD ± 65.1), respectively. Confirmed symptomatic hypoglycaemia occurred in 38.3% of participants (ADA level 1: 35.8%; level 2: 15.4%; level 3: 0.0%). CONCLUSIONS: iGlarLixi initiation was associated with improved glycaemic control, without body weight gain or increased hypoglycaemia over 24 weeks.

• Klíčová slova
• clinical trial, iGlarLixi, insulin glargine, lixisenatide, phase IV study, type 2 diabetes,
• MeSH
• diabetes mellitus 2. typu * farmakoterapie   krev   MeSH
• dospělí MeSH
• fixní kombinace léků MeSH
• glykovaný hemoglobin analýza   MeSH
• hypoglykemie chemicky indukované   MeSH
• hypoglykemika * aplikace a dávkování   škodlivé účinky   terapeutické užití   MeSH
• inzulin glargin * aplikace a dávkování   škodlivé účinky   terapeutické užití   MeSH
• krevní glukóza účinky léků   MeSH
• lidé středního věku MeSH
• lidé MeSH
• náhrada léků * MeSH
• peptidy * aplikace a dávkování   škodlivé účinky   terapeutické užití   MeSH
• receptor pro glukagonu podobný peptid 2 MeSH
• rozvrh dávkování léků MeSH
• senioři MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze IV MeSH
• multicentrická studie MeSH
• Názvy látek
• fixní kombinace léků MeSH
• glykovaný hemoglobin MeSH
• hemoglobin A1c protein, human MeSH Prohlížeč
• hypoglykemika * MeSH
• inzulin glargin * MeSH
• krevní glukóza MeSH
• lixisenatide MeSH Prohlížeč
• peptidy * MeSH
• receptor pro glukagonu podobný peptid 2 MeSH

The impact of the humanitarian crisis in Venezuela on care for noncommunicable diseases (NCDs) such as diabetes is unknown. This study aims to document health system performance for diabetes management in Venezuela during the humanitarian crisis. This longitudinal study on NCDs is nationally representative at baseline (2014-2017) and has follow-up (2018-2020) data on 35% of participants. Separate analyses of the baseline population with diabetes (n = 585) and the longitudinal population with diabetes (n = 210) were conducted. Baseline analyses constructed a weighted care continuum: all diabetes; diagnosed; treated; achieved glycaemic control; achieved blood pressure, cholesterol, and glycaemic control; and achieved aforementioned control plus non-smoking. Weighted multinomial regression models controlling for region were used to estimate the association between socio-demographic characteristics and care continuum stage. Longitudinal analyses constructed an unweighted care continuum: all diabetes; diagnosed; treated; and achieved glycaemic control. Unweighted multinomial regression models controlling for region were used to estimate the association between socio-demographic characteristics and changes in care continuum stage. Among 585 participants with diabetes at baseline, 71% were diagnosed, 51% were on treatment, and 32% had achieved glycaemic control. Among 210 participants with diabetes in the longitudinal population, 50 (24%) participants' diabetes management worsened, while 40 (19%) participants improved. Specifically, the proportion of those treated decreased (60% in 2014-2017 to 51% in 2018-2020), while the proportion of participants achieving glycaemic control did not change. Although treatment rates have declined substantially among people with diabetes in Venezuela, management changed less than expected during the crisis.

• Publikační typ
• časopisecké články MeSH

Given the progressive nature of type 2 diabetes (T2D), most individuals with the disease will ultimately undergo treatment intensification. This usually involves the stepwise addition of a new glucose-lowering agent or switching to a more complex insulin regimen. However, complex treatment regimens can result in an increased risk of hypoglycaemia and high treatment burden, which may impact negatively on both therapeutic adherence and overall quality of life. Individuals with good glycaemic control may also be overtreated with unnecessarily complex regimens. Treatment simplification aims to reduce individual treatment burden, without compromising therapeutic effectiveness or safety. Despite data showing that simplifying therapy can achieve good glycaemic control without negatively impacting on treatment efficacy or safety, it is not always implemented in clinical practice. Current clinical guidelines focus on treatment intensification, rather than simplification. Where simplification is recommended, clear guidance is lacking and mostly focused on treatment of the elderly. An expert, multidisciplinary panel evaluated the current treatment landscape with respect to guidance, published evidence, recommendations and approaches regarding simplification of complex insulin regimens. This article outlines the benefits of treatment simplification and provides practical recommendations on simplifying complex insulin treatment strategies in people with T2D using illustrative cases.

• Klíčová slova
• Antidiabetic drug, Glycaemic control, Insulin therapy, Primary care, Type 2 diabetes,
• Publikační typ
• časopisecké články MeSH
• přehledy MeSH

Type 2 diabetes (T2D), chronic kidney disease (CKD), atherosclerotic cardiovascular disease (ASCVD), and heart failure (HF)-along with their associated risk factors-have overlapping etiologies, and two or more of these conditions frequently occur in the same patient. Many recent cardiovascular outcome trials (CVOTs) have demonstrated the benefits of agents originally developed to control T2D, ASCVD, or CKD risk factors, and these agents have transcended their primary indications to confer benefits across a range of conditions. This evolution in CVOT evidence calls for practice recommendations that are not constrained by a single discipline to help clinicians manage patients with complex conditions involving diabetes, cardiorenal, and/or metabolic (DCRM) diseases. The ultimate goal for these recommendations is to be comprehensive yet succinct and easy to follow by the nonexpert-whether a specialist or a primary care clinician. To meet this need, we formed a volunteer task force comprising leading cardiologists, nephrologists, endocrinologists, and primary care physicians to develop the DCRM Practice Recommendations, a multispecialty consensus on the comprehensive management of the patient with complicated metabolic disease. The task force recommendations are based on strong evidence and incorporate practical guidance that is clinically relevant and simple to implement, with the aim of improving outcomes in patients with DCRM. The recommendations are presented as 18 separate graphics covering lifestyle therapy, patient self-management education, technology for DCRM management, prediabetes, cognitive dysfunction, vaccinations, clinical tests, lipids, hypertension, anticoagulation and antiplatelet therapy, antihyperglycemic therapy, hypoglycemia, nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), ASCVD, HF, CKD, and comorbid HF and CKD, as well as a graphical summary of medications used for DCRM.

• Klíčová slova
• Atherosclerotic cardiovascular disease, Chronic kidney disease, Clinical practice, Consensus recommendations, Heart failure, Type 2 diabetes,
• MeSH
• chronická renální insuficience * komplikace   epidemiologie   terapie   MeSH
• diabetes mellitus 2. typu * komplikace   epidemiologie   terapie   MeSH
• hypoglykemika terapeutické užití   MeSH
• kardiovaskulární nemoci * komplikace   epidemiologie   prevence a kontrola   MeSH
• kardiovaskulární systém * MeSH
• lidé MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• práce podpořená grantem MeSH
• přehledy MeSH
• Názvy látek
• hypoglykemika MeSH

The glycemic response to ingested glucose for the treatment of hypoglycemia following exercise in type 1 diabetes patients has never been studied. Therefore, we aimed to characterize glucose dynamics during a standardized bout of hypoglycemia-inducing exercise and the subsequent hypoglycemia treatment with the oral ingestion of glucose. Ten male patients with type 1 diabetes performed a standardized bout of cycling exercise using an electrically braked ergometer at a target heart rate (THR) of 50% of the individual heart rate reserve, determined using the Karvonen equation. Exercise was terminated when hypoglycemia was reached, followed by immediate hypoglycemia treatment with the oral ingestion of 20 g of glucose. Arterialized blood glucose (ABG) levels were monitored at 5 min intervals during exercise and for 60 min during recovery. During exercise, ABG decreased at a mean rate of 0.11 ± 0.03 mmol/L·min-1 (minimum: 0.07, maximum: 0.17 mmol/L·min-1). During recovery, ABG increased at a mean rate of 0.13 ± 0.05 mmol/L·min-1 (minimum: 0.06, maximum: 0.19 mmol/L·min-1). Moreover, 20 g of glucose maintained recovery from hypoglycemia throughout the 60 min postexercise observation window.

• Klíčová slova
• exercise, glycemic excursion, hypoglycemia, hypoglycemia treatment, insulin therapy, type 1 diabetes,
• MeSH
• aplikace orální MeSH
• cvičení * MeSH
• cyklistika MeSH
• diabetes mellitus 1. typu krev   farmakoterapie   MeSH
• dospělí MeSH
• glukosa aplikace a dávkování   MeSH
• hypoglykemie farmakoterapie   MeSH
• inzulin krev   MeSH
• krevní glukóza analýza   MeSH
• lidé MeSH
• pilotní projekty MeSH
• srdeční frekvence MeSH
• Check Tag
• dospělí MeSH
• lidé MeSH
• mužské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• glukosa MeSH
• inzulin MeSH
• krevní glukóza MeSH