Efficacy, safety, and legal considerations of do-it-yourself artificial pancreas systems: a position statement from italian diabetes societies.

Do-It-Yourself Artificial Pancreas Systems (DIY-APS)-which combine commercially available devices with open-source software-are increasingly used for the management of type 1 diabetes, despite a lack of formal regulatory approval in many jurisdictions, including in Italy. This position statement, endorsed by Italian diabetes societies (Associazione Medici Diabetologici, Societa Italiana di Diabetologia, and Società Italiana di Endocrinologia e Diabetologia Pediatrica) and "Diabete Italia", the national patient association, addresses the efficacy, safety, and legal implications of DIY-APS in Italy. Real-world evidence and clinical trials demonstrate that DIY-APS improves glycemic control and quality of life and reduce fear of hypoglycemia in users.

Continuous Glucose Monitoring Metrics and Continuous Glucose Monitoring-Based Hypoglycemia, Including Duration, in Individuals with Type 1 Diabetes Switching to Once-Weekly Insulin Icodec: A Post Hoc Evaluation of ONWARDS 6.

Post hoc evaluation of ONWARDS 6 assessed continuous glucose monitoring (CGM) metrics and CGM-based hypoglycemia with once-weekly insulin icodec (icodec) and once-daily insulin degludec (degludec) in adults with type 1 diabetes. Open CGM data were collected throughout ONWARDS 6. During weeks 0-4, 22-26, and 48-52, time in range (TIR; 3.

Enhancing Type 2 Diabetes Care With CGM Integration: Insights From an Italian Expert Group.

Type 2 diabetes (T2D) is a pandemic and strongly impact patients' prognosis. Several barriers may hamper the achievement of good glycaemic control, which is the aim of diabetes care. These include but are not limited to poor treatment adherence, poor self-management, and heterogeneity of the disease context.

An overview of the FreeStyle Libre monitoring system for individuals with type 1 and type 2 diabetes.

Introduction: Diabetes is a chronic disease with high prevalence, necessitating advanced technology to achieve glycemic targets and reduce complications. Continuous glucose monitoring (CGM) has become a cornerstone in diabetes management, with the Freestyle Libre (FSL) systems being some of the most widely used devices.

Areas Covered: This review focuses on FSL systems, each including an all-in-one sensor and transmitter, a handheld reader and a Mobile Medical App (MMA).

Tips for successful use of commercial automated insulin delivery systems: An expert paper of the Italian working group on diabetes and technology.

In recent years, automated insulin delivery (AID) systems have transformed diabetes care with demonstrated benefits in glucose control, hypoglycemia risk, and psychosocial outcomes. Given that different systems show peculiarities in terms of components, approved indications of use, type of algorithm, modifiable settings, and additional features, with this expert paper, we aim to provide healthcare professionals with device-specific recommendations for the optimization of insulin therapy and diabetes self-management with the five commercial AID systems most commonly used in Italy. In detail, we provide educational tips and suggestions for adjustment of insulin dosing parameters to address specific glucose patterns as depicted by continuous glucose monitoring data and effectively manage physical activity or exercise.

The Utility of Smart Multiple Daily Injection Systems in Intensive Insulin-Treated People With Diabetes: An Italian Expert Consensus.

Background: Smart systems for multiple daily injections (Smart MDI) integrate continuous glucose monitoring, connected insulin pens, smartphone apps, and cloud-based data storage to provide bolus and corrective dose suggestions, reminders/alerts, automatic tracking and sharing of insulin therapy, and glycemic data to users, caregivers, and providers. This is an expert consensus on the clinical value of Smart MDI and critical points for implementation in adults and children/adolescents with diabetes.

Methods: A nominal group technique combined with the estimate-talk-estimate approach was employed to achieve consensus among panel members from the Italian Intersociety Technology and Diabetes Study Group with expertise in pediatric and adult diabetes care.

Criteria for Personalised Choice of a Continuous Glucose Monitoring System: An Expert Opinion.

Despite the growing evidence supporting the outpatient use of continuous glucose monitoring (CGM) for improving glycaemic control and reducing hypoglycaemia, there is a need for a detailed understanding of the specific features of CGM devices that best meet individual patient needs. This expert opinion, based on a comprehensive literature review and the personal perspectives of clinicians, aims to provide the healthcare professionals (HCPs) with a comprehensive framework for selecting CGM devices. It evaluates the current state of CGM technology, categorizing features into essential features, major drivers of choice, and additional/useful features.

The potential of glucose management indicator for the estimation of glucose disposal rate in people with type 1 diabetes.

Background And Aims: Insulin resistance is a growing feature in type 1 diabetes (T1D). It can be quantified by calculating the estimated glucose disposal rate (eGDR) with the Epstein's formula, which includes laboratory-measured glycated hemoglobin (HbA1c). We aimed the current research to assess the agreement between the conventional eGDR formula and an alternative one (eGDR-GMI) incorporating the glucose management indicator (GMI) derived from continuous glucose monitoring (CGM).

Yoga as an alternative to cycling in type 1 diabetes: A preliminary study of acute effects on glucose levels.

We evaluated the acute effects of yoga compared to cycling on glucose change and variability, and the occurrence of hypoglycemia in adults with type 1 diabetes. Fifteen participants performed 50 min of cycling or yoga. Glucose values were collected before and after exercise.

The relationship between endothelial-dependent flow-mediated dilation and diastolic function in type 2 diabetes.

Aims: Diastolic dysfunction represents the earliest and most common manifestation of diabetic cardiomyopathy. Nitric oxide (NO), a potent vasodilator and anti-inflammatory mediator released from the subendocardial and coronary endothelium, favors left ventricular distensibility and relaxation. In type 2 diabetes (T2D), the NO bioavailability is reduced due to the oxidative stress and inflammatory state of the endothelium, because of chronic hyperglycemia.

T-cell immunity against Severe Acute Respiratory Syndrome Coronavirus 2 proteins in patients with type 1 diabetes.

Aims: Individuals with type 1 diabetes (T1D) do not appear to have an elevated risk of severe Coronavirus Disease 19 (COVID-19). Pre-existing immune reactivity to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in unexposed individuals may serve as a protective factor. Hence, our study was designed to evaluate the existence of T cells with reactivity against SARS-CoV-2 antigens in unexposed patients with T1D.

Diabetes as a risk factor for pneumococcal disease and severe related outcomes and efficacy/effectiveness of vaccination in diabetic population. Results from meta-analysis of observational studies.

Aims: To collect all available evidence on the effect of diabetes mellitus (DM) as a risk factor for pneumococcal disease incidence and related complications, and on the efficacy/effectiveness of vaccines in patients with DM.

Methods: Two distinct systematic searches on MEDLINE, Cochrane, ClinicalTrials.gov and EMBASE databases were performed, one for each meta-analysis, collecting all observational (cohort and case-control) studies and randomized clinical trials performed on humans up to June 1st, 2023.

Elevated blood flow in people with type 1 and type 2 diabetes.

Aims: The study aimed to evaluate blood flow (BF) and microvascular function in the forearm of people with type 1 and type 2 diabetes at rest and after ischemia. Microvascular function plays a crucial role in regulating BF in peripheral tissues based on metabolic demand.

Methods: People with diabetes and sex-matched healthy controls were recruited.

Digital technology and healthcare delivery in insulin-treated adults with diabetes: a proposal for analysis of self-monitoring blood glucose patterns using a dedicated platform.

Purpose: A remote platform for diabetes care (Roche Diabetes® Care Platform, RDCP) has been developed that allows combined face-to-face consultations and remote patient monitoring (RPM).

Methods: A dedicated flowchart is proposed as a clinical approach to help healthcare professionals in the appropriate interpretation of structured self-monitoring blood glucose data, as visualized on the RDCP during the visits, and in the optimal management of patients using the integrated RDCP-RPM tools.

Results: The platform organizes patterns in different blocks: (i) hypoglycemia; (ii) hyperglycemia; (iii) blood glucose variability; (iv) treatment adherence, which identifies a possible individual pattern according to glycemic control challenges, potential causal factors, and behavioral type patterns.

Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial.

Background: ONWARDS 6 compared the efficacy and safety of once-weekly subcutaneous insulin icodec (icodec) and once-daily insulin degludec (degludec) in adults with type 1 diabetes.

Methods: This 52-week (26-week main phase plus a 26-week safety extension), randomised, open-label, treat-to-target, phase 3a trial was done at 99 sites across 12 countries. Adults with type 1 diabetes (glycated haemoglobin [HbA] <10·0% [86 mmol/mol]) were randomly assigned (1:1) to once-weekly icodec or once-daily degludec, both in combination with insulin aspart (two or more daily injections).

An updated algorithm for an effective choice of continuous glucose monitoring for people with insulin-treated diabetes.

Purpose: Continuous Glucose Monitoring (CGM) is a key tool for insulin-treated people with diabetes (PwD). CGM devices include both real-time CGM (rtCGM) and intermittently scanned CGM (isCGM), which are associated with an improvement of glucose control and less hypoglycemia in clinical trials of people with type 1 and type 2 diabetes.

Methods: This is an expert position to update a previous algorithm on the most suitable choice of CGM for insulin-treated PwD in light of the recent evidence and clinical practice.

Continuous glucose monitoring (CGM) in a non-Icu hospital setting: The patient's journey.

Aims: Although consistent data support the outpatient use of continuous glucose monitoring (CGM) to improve glycemic control and reduce hypoglycemic burden, and clinical outcomes, there are limited data regarding its use in the hospital setting, particularly in the non-intensive care unit (non-ICU) setting. The emerging use of CGM in the non-critical care setting may be useful in increasing the efficiency of hospital care and reducing the length of stay for patients with diabetes while improving glycemic control.

Data Synthesis: The purpose of this Expert Opinion paper was to evaluate the state of the art and provide a practical model of how CGM can be implemented in the hospital.

Continuous Glucose Monitoring-Derived Metrics and Capillary Vessel Density in Subjects with Type 1 Diabetes without Diabetic Retinopathy.

Optical coherence tomography angiography (OCTA) is an innovative and reliable technique detecting the early preclinical retinal vascular change in patients with diabetes. We have designed our study to evaluate whether an independent relationship exists between continuous glucose monitoring (CGM)-derived glucose metrics and OCTA parameters in young adult patients with type 1 diabetes without diabetic retinopathy (DR). Inclusion criteria were age ≥ 18 years, diagnosis of type 1 diabetes from ≥ 1 year, stable insulin treatment in the last three months, use of real-time CGM, and CGM wear time ≥ 70%.

A Head-to-Head Comparison of Two Algorithms for Adjusting Mealtime Insulin Doses Based on CGM Trend Arrows in Adult Patients with Type 1 Diabetes: Results from an Exploratory Study.

Background: Continuous glucose monitoring (CGM) users are encouraged to consider trend arrows before injecting a meal bolus. We evaluated the efficacy and safety of two different algorithms for trend-informed bolus adjustments, the Diabetes Research in Children Network/Juvenile Diabetes Research Foundation (DirectNet/JDRF) and the Ziegler algorithm, in type 1 diabetes.

Methods: We conducted a cross-over study of type 1 diabetes patients using Dexcom G6.

The Effect of Two Different Insulin Formulations on Postprandial Hyperglycemia after High and Low Glycemic-Index Meal in Type 1 Diabetes.

Despite multiple pharmacological options, including rapid-acting insulin analogs, postprandial hyperglycemia is still highly prevalent in patients with type 1 and type 2 diabetes. We hypothesize that the new rapid-acting insulin formulation, the so-called faster-acting Aspart, may have a different effect in controlling postprandial hyperglycemic burden according to the quality of the meal compared to the traditional Aspart. Twenty-five patients with type 1 diabetes were consecutively recruited at the diabetes care center of the University Hospital affiliate of the Magna Græcia University of Catanzaro.