Glycemia Around Exercise in Adults with Type 1 Diabetes Using Automated and Nonautomated Insulin Delivery Pumps: A Switch Pilot Trial.

In an in-patient switch study, 10 adults with type 1 diabetes (T1D) performed 45 min of moderate-intensity exercise on 2 occasions: (1) when using their usual insulin pump (UP) and (2) after transitioning to automated insulin delivery (AID) treatment (MiniMed™ 780G). Consensus glucose management guidelines for performing exercise were applied. Plasma glucose concentrations measured over a 3-h monitoring period were stratified into time below range (TBR, <3.9 mmol/L), time in range (TIR, 3.9-10.0 mmol/L), and time above range (TAR, >10.0 mmol/L). Overall, TBR (UP: 11 ± 21 vs. AID: 3% ± 10%, P = 0.413), TIR (UP: 53 ± 27 vs. AID: 66% ± 39%, P = 0.320), and TAR (UP: 37 ± 34 vs. AID: 31% ± 41%, P = 0.604) were similar between arms. A proportionately low number of people experienced exercise-induced hypoglycemia (UP: n = 2 vs. AID: n = 1, P = 1.00). In conclusion, switching to AID therapy did not alter patterns of glycemia around sustained moderate-intensity exercise in adults with T1D. Clinical Trial Registration number: NCT05133765.

Efficacy and safety of closed-loop insulin delivery versus sensor-augmented pump in the treatment of adults with type 1 diabetes: a systematic review and meta-analysis of randomized-controlled trials.

BACKGROUND: Controversy remains regarding whether closed-loop (CL) insulin delivery or insulin sensor-augmented pump (SAP) delivery is more efficient for clinical treatment. Therefore, we aimed to compare the efficacy and safety of CL insulin delivery systems versus insulin SAP delivery for adults with type 1 diabetes (T1D). METHODS: Embase, Ovid MEDLINE, PubMed, ScienceDirect, Scopus, the Cochrane Library, and other databases were searched for related articles, and we analyzed the average blood glucose (BG), time in range (TIR), and adverse effects (AEs) as primary endpoints to evaluate efficacy and safety. RESULTS: Of 1616 articles, 12 randomized-controlled trials (RCTs) were included in the final analysis. Regarding BG control efficacy, CL insulin delivery resulted better outcomes than SAP therapy with regard to the average BG value, which was detected and recorded by continuous glucose monitoring (mean difference [MD][mmol/L]:  - 0.25 95% confidence interval [CI]  - 0.42 to - 0.08, p = 0.003); TIR 3.9-10 mmol/L (MD [%]: 7.91 95% CI 4.45-11.37, p < 0.00001). Similar results were observed for the secondary outcomes including low blood glucose index (LBGI) (MD:  - 0.41 95% CI - 0.55 to - 0.26, p < 0.00001), high blood glucose index (HBGI) (MD:  - 2.56 95% CI - 3.38 to - 1.74, p < 0.00001), and standard deviation (SD) of glucose variability (MD [mmol/L]: -0.25 95% CI - 0.44 to - 0.06, p = 0.01). Furthermore, SAP therapy was associated with more adverse effects (risk ratio: 0.20 95% CI 0.07-0.52, p = 0.001) than CL insulin delivery, and one of the most common adverse effects was hypoglycemia. CONCLUSIONS: CL insulin delivery appears to be a better treatment method than SAP therapy for adults with T1D because of its increased BG control efficacy and decreased number of hypoglycemic events.

Accuracy assessment of bolus and basal rate delivery of different insulin pump systems used in insulin pump therapy of children and adolescents.

BACKGROUND: Continuous subcutaneous insulin infusion (CSII) is commonly used in patients with diabetes. Accurate and reliable delivery by insulin pumps is essential for a safe and effective therapy, particularly when using small doses. In this study, accuracy of bolus and basal rate delivery of various available insulin pumps was evaluated. METHODS: In total, 13 insulin pump systems were tested: eight durable pumps with different infusion sets and one patch pump. Based on IEC 60601-2-24, insulin delivery was measured by recording weight gain of a beaker into which insulin was infused by the pumps. Bolus accuracy was determined by individually weighing 25 consecutive 0.1 or 1.0 U boluses and basal rate accuracy was determined during basal rate delivery of 0.1 or 1.0 U/h for 72 hours. For analyses, basal rate delivery was divided into 1-hour windows and deviation from target was calculated. RESULTS: Regarding different systems, average 0.1 U bolus delivery was -2% to +9% of the intended volume with 53% to 96% of boluses within ±15% of target. During 0.1 U/h basal rate delivery, most pumps showed an initial over-delivery for the first few hours. Three systems reached a total basal rate error <5%; others showed up to +24%. In general, delivery was more accurate when using larger doses. CONCLUSIONS: Considerable differences in insulin delivery accuracy were observed between the tested pumps. In general, when using very low doses, accuracy of insulin delivery is limited in most insulin pumps. This should be considered for CSII therapy in children.

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device. Final order.

The Food and Drug Administration (FDA or we) is classifying the insulin therapy adjustment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the insulin therapy adjustment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Documento de consenso sobre el tratamiento con infusión subcutánea continua de insulina en el medio hospitalario / Position statement on continuous subcutaneous insulin infusion in the hospital setting

En España hay un número creciente de personas con diabetes tipo 1 tratadas con la terapia de infusión subcutánea continua de insulina (ISCI), pero no hay directrices nacionales sobre cómo manejar la terapia con bomba de insulina en el ámbito hospitalario. El Grupo de Nuevas Tecnologías de la Sociedad Española de Diabetes ha revisado la literatura y varias directrices internacionales y propone un documento de consenso sobre el manejo de la terapia con bomba de insulina para los pacientes hospitalizados. El documento contiene recomendaciones sobre las indicaciones, las contraindicaciones y los requisitos necesarios para el mantenimiento de la terapia con ISCI en el hospital. Esta revisión proporciona una guía para el manejo de pacientes ISCI en entornos especiales, tales como la sala de urgencias, cirugía, parto y para pacientes pediátricos. Por último, el grupo propone un conjunto de documentos necesarios para establecer una política ISCI en el hospital. En conclusión, la terapia con ISCI se puede utilizar con seguridad en el hospital en pacientes seleccionados después de haberse implementado un protocolo estandarizado

There is an increasing number of people with type 1 diabetes treated with continuous subcutaneous insulin infusion therapy (CSII) in Spain, but there are no national guidelines on how to manage insulin pump therapy in the hospital setting. The Group on New Technologies in Diabetes of the Spanish Diabetes Society has reviewed the literature and several international guidelines, and proposes a consensus document on the management of insulin pump therapy for inpatients. The document contains recommendations on indications, contraindications and the requirements needed to maintaining CSII therapy. This review provides a guide for the management of CSII patients in special settings such as the emergency room, surgery, delivery, and for pediatric patients. Finally, the group proposes a set of documents needed to establish a CSII policy in the hospital. In conclusion, CSII therapy can safely be used in the hospital in selected patients after the implementation of a standardized protocol

Transition of continuous subcutaneous insulin infusion systems in a very short time frame as a consequence of a public tender process

AIM: The procurement of pumps/supplies through a tender process is common practice among public services. A report is presented on the feasibility and safety of the transition from one continuous subcutaneous insulin infusion (CSII) system to another within a very short time frame (4-weeks) as the consequence of a public tender. METHODS: The program consisted of: Session-1 was a system start-up training session. Patient satisfaction was evaluated. Session-2 consisted of a call from technical staff 72 h after Session- 1 to provide support regarding the programming or the change of infusion set. Session-3 was a training session regarding the use of therapy management software. During and 2 months after Session-2, clinical events, technical issues, and training reinforcement incidents were registered. HbA1c data were collected retrospectively. RESULTS: A total of 219 patients were enrolled. During the second week, 81% of patients weretransferred to the new system. Patient overall satisfaction scored 9.4/10 (none <7). There were 30 training reinforcement events and 7 technical issues, with all 37 of them being were sorted out over the telephone. There were 31 additional clinical events (infusion set issues). Twentyfour were considered mild, and were solved by phone technical support. Medical assistance was needed in six (five unexpected hyperglycemia, one ketosis). There was only one severe event (ketoacidosis requiring hospitalization). HbA1c did not deteriorate during the transition process. One hundred twenty-eight patients attended the therapy management software training. CONCLUSIONS: With the assistance of a specific program, a complete switch to a new insulin pump in a large population of patients with T1D in the context of a public tender in a very short time was carried out safely and without deterioration of metabolic control

INTRODUCCIÓN: El sistema público de salud financia la utilización de infusores subcutáneos de insulina (ISCI) como tratamiento no convencional en pacientes con diabetes mellitus tipo 1 (DT1). En este contexto, y con el fin de mejorar la eficiencia, es frecuente que los centros encargados de este tipo de terapia utilicen procedimientos de licitación. Nuestro objetivo fue evaluar la eficacia y la seguridad de un proceso de recambio de dispositivos ISCI a llevar a cabo en un breve periodo (4 semanas) en un procedimiento de concurso público. PACIENTES Y MÉTODOS: El proceso de recambio incluyó 3 sesiones precedidas por la presentación y la justificación del mismo: sesión 1: adiestramiento en la utilización del nuevo dispositivo ISCI y administración de una encuesta de satisfacción; sesión 2: contacto telefónico de soporte a las 72 h de iniciado el programa a la búsqueda de incidencias, y sesión 3: a los 3 meses, sesión de refuerzo/consolidación de los conocimientos y adiestramiento en el uso de programa informático de gestión del tratamiento. Durante 2 meses se recogieron todas las incidencias clínicas y técnicas. Retrospectivamente, se obtuvo la HbA1c más cercana al inicio y la primera una vez finalizado el programa. RESULTADOS: Se efectuó el recambio en 219 pacientes, el 81% de los recambios se efectuó en las 2 primeras semanas. En la encuesta de satisfacción realizada se obtuvo una puntuación media de 9,4 sobre 10. Se efectuaron un total de 30 llamadas telefónicas extra con el fin de reforzar aspectos educativos y en 7 ocasiones se atendieron incidencias técnicas que fueron resueltas de manera inmediata. Veinticuatro de 31 eventos clínicos registrados fueron considerados de carácter leve. Seis de ellos fueron moderados (5 hiperglucemias simples/1 cetosis). Un evento fue catalogado como grave (cetoacidosis diabética). Todos los eventos se relacionaron con el equipo de infusión (recambio) y en todos se resolvieron de manera satisfactoria. La HbA1c tras el recambio no cambió significativamente. Ciento veintiocho pacientes acudieron al adiestramiento en el uso del programa informático de gestión del tratamiento. CONCLUSIONES: En el contexto de un proceso de licitación y bajo un programa diseñado específicamente, el recambio de dispositivos ISCI puede realizarse de manera segura y sin deterioro alguno en el control metabólico en un considerable número de pacientes y en un corto periodo

Psychosocial aspects of closed- and open-loop insulin delivery: closing the loop in adults with Type 1 diabetes in the home setting.

AIMS: To explore the psychosocial experiences of closed-loop technology and to compare ratings of closed- and open-loop technology for adults with Type 1 diabetes taking part in a randomized crossover study. METHODS: Adults (aged > 18 years) on insulin pump therapy were recruited to receive a first phase of either real-time continuous glucose monitoring with overnight closed-loop or real-time continuous glucose monitoring alone (open-loop) followed by a second phase of the alternative treatment in random order, at home for 4 weeks, unsupervised. Participants were invited to share their views in semi-structured interviews. The impact of the closed-loop technology, positive and negative aspects of living with the device overnight, along with the hopes and anxieties of the participants, were explored. RESULTS: The participants in the trial were 24 adults with a mean (sd) age of 43 (12) years, of whom 54% were men. The mean (range) interview duration was 26 (12-46) min. Content and thematic analysis showed the following key positive themes: improved blood glucose control (n = 16); reassurance/reduced worry (n = 16); improved overnight control leading to improved daily functioning and diabetes control (n = 16); and improved sleep (n = 8). The key negative themes were: technical difficulties (n = 24); intrusiveness of alarms (n = 13); and size of equipment (n = 7). Of the 24 participant, 20 would recommend the closed-loop technology. CONCLUSIONS: Closed-loop therapy has positive effects when it works in freeing participants from the demands of self-management. The downside was technical difficulties, particularly concerning the pump and 'connectivity', which it is hoped will improve. Future research should continue to explore the acceptability of the closed-loop system as a realistic therapy option, taking account of user concerns as new systems are designed. Failure to do this may reduce the eventual utility of new systems.

Tratamiento con infusión subcutánea continua de insulina en niños de corta edad / Treatment with continuous subcutaneous insulin infusion in infants and toddlers

La incidencia de la diabetes mellitus tipo 1 (DM1) ha aumentado de forma importante en lactantes y preescolares. Los estudios epidemiológicos efectuados a escala europea muestran un incremento significativo de la tasa de incidencia de DM1 en niños menores de 5 años. Alcanzar los objetivos glucémicos en este grupo de edad no es sencillo, como reconocen los pediatras diabetólogos. Los niños de corta edad son particularmente susceptibles a la hiperglucemia y a la hipoglucemia como consecuencia de las grandes variaciones en la actividad física, los patrones de ingesta impredecibles, la presencia de infecciones intercurrentes frecuentes y la dificultad de administrar pequeñas dosis de insulina de acción rápida e intermedia. Además, existe una creciente preocupación por las posibles secuelas neurológicas de las hipoglucemias graves en los niños de corta edad. En la última década, el tratamiento con infusor subcutáneo continuo de insulina (ISCI) se ha mostrado eficaz para lograr los objetivos glucémicos en la DM1. Los beneficios del tratamiento con ISCI han quedado demostrados en adolescentes y adultos. Sin embargo, hasta hace poco había escasos trabajos que valoraran la eficacia y la seguridad de este tipo de tratamiento en niños pequeños. Las indicaciones más frecuentes en lactantes y preescolares del tratamiento con ISCI, que se asocia a una menor variabilidad glucémica en niños, son la presencia de hipoglucemias recurrentes y/o control glucémico deficiente, y la necesidad de flexibilidad en el estilo de vida. El objetivo de este artículo es exponer los principios del tratamiento con ISCI en los niños de corta edad y revisar algunos trabajos de la bibliografía sobre esta población

The incidence of type 1 diabetes (T1D) seems to be increasing at an alarming rate in toddlers and preschool-aged children. Epidemiological studies carried out in Europe report significant increases in the incidence rates of diabetes in children younger than 5 years of age. Pediatric diabetologists are well aware of the difficulty in achieving glycemic targets in this age group. This challenging population is particularly susceptible to both hyperglycemia and hypoglycemia as a result of wide fluctuations in physical activity from day to day, unpredictable eating habits, frequent intercurrent infections, and difficulties in administering very small doses of rapid- and intermediateacting insulin. Furthermore, there are also heightened concerns that severe hypoglycemic events may cause neurological sequelae in infants and toddlers. Over the last decade, continuous subcutaneous insulin infusion (CSII) has emerged as an increasingly popular treatment modality for achieving intensive glycemic control in T1D. The benefits of pump therapy have been well demonstrated in adults and adolescents. However, until recently, there has been a paucity of studies examining the efficacy and safety of pump therapy in very young children. Therapy with CSII, which is associated with lower blood glucose variability in children, is indicated in this patient population in cases of recurrent hypoglycemia and/or poor glycemic control. Moreover, it increases flexibility in lifestyle. The purpose of this article is to discuss the rationale for insulin pump therapy in infants and toddlers and to review some of the available studies of pump therapy in this population

Classification of distinct baseline insulin infusion patterns in children and adolescents with type 1 diabetes on continuous subcutaneous insulin infusion therapy.

OBJECTIVE: We hypothesized systematic differences in the patterns of programmed basal insulin infusion rates in children and adolescents with type 1 diabetes on continuous subcutaneous insulin infusion (CSII). We aimed at classification of basal insulin infusion rate regimens and comparing patients' underlying clinical characteristics. RESEARCH DESIGN AND METHODS: The German/Austrian diabetes data acquisition system for prospective surveillance database for quality control and scientific surveys in pediatric diabetology served as the primary data source. Latest (September 2004) basal insulin infusion rates of all 1,248 patients with type 1 diabetes on CSII (0.38-18 years) were analyzed (dataset 1). Basal insulin infusion rates per hour were expressed relative to mean basal insulin infusion rates per 24 h. Unsupervised clustering was used to classify basal insulin infusion rate patterns. Clinical characteristics of patients falling into distinct basal insulin infusion rate clusters were compared by Kruskal-Wallis test. Changes of basal insulin infusion rates in 64 patients were followed from initial settings before CSII to latest programming in an independent dataset 2. RESULTS: Seven different basal insulin infusion rate patterns occurred in dataset 1. A dawn-dusk pattern was used in 708 patients (14.9 +/- 2.4 years) with the peak basal insulin infusion rate at 5 a.m. Additional patterns showed only one basal insulin infusion rate oscillation per 24 h with a backshift of peak basal insulin infusion rates in younger children (P < 0.000001) (1 A.M.: n = 152, 12.4 years and 9 P.M.: n = 117, 8.9 years). All but two patients in dataset 2 were initially set on dawn-dusk patterns but showed a comparable diversification of basal insulin infusion rates during follow-up with backshift of peak basal insulin infusion rates in younger children (P < 0.01). CONCLUSIONS: Pediatric diabetologists shape distinct basal insulin infusion rate profiles during treatment of CSII patients, mainly reflecting differences in age. Our data strongly suggest that age-dependent endocrine changes during childhood (e.g., puberty) affect circadian distribution of insulin needs in CSII, which should be kept in mind when considering basal insulin infusion rate strategies in children and adolescents.

Terapia con infusión subcutánea continua de insulina (ISCI): cálculo individualizado del “bolus” y de la línea basal / Therapy with continous subcutaneous insulin infusion (CSII): individualized calculation of bolus and basal rate

Para poder iniciarse como grupo en el tratamiento con sistemas de infusión continua subcutánea de insulina (ISCI) es necesario disponer de una serie de medios y de personal, y así poder conseguir los mejores resultados con este tipo de terapia. En este capítulo se describen los algoritmos básicos para que se puedan diseñar las pautas de insulina con ISCI al inicio de un tratamiento. Estos algoritmos tienen como objetivo calcular la dosis total de insulina que un paciente con ISCI va a necesitar, así como repartir esta dosis total de insulina calculada en forma de línea basal y de “bolus”. Se describen también los algoritmos de ayuda para poder calcular los “bolus” de insulina necesaria según la cantidad de carbohidratos que componen una comida determinada, así como la cantidad de insulina necesaria para tratar hiperglucemias puntuales. La información que se obtiene mediante la utilización de algoritmos se debe tomar con cierta cautela y sólo serán una forma de ayuda al inicio de un tratamiento con ISCI y posteriormente se irán adaptando en función de las características de cada paciente

Before a professional team intents to begin a subcutaneous continuous insulin infusion (CSII) therapy program is necessary to have enough resources and personal to achieve the best results with this therapy. In this chapter, basic algorithms to design initial appropriate doses with CSII therapy will be described. These algorithms show how to calculate total insulin doses that will be required for patients treated with CSII and how to distribute them as basal rate or bolus. Furthermore, additional help tools were introduced to estimate how much bolus will be used to cover the carbohydrate content of a meal or to correct for occasional high blood glucose values. The information delivered by the different algorithm exposed needs to be considered cautiously and will be considered only as a guidance before starting CSII therapy. Then, these algorithms require to be adapted to individual patient characteristics in the following visits

Resource guide 2004. Insulin delivery.

Syringes...pumps...jet infectors...pens...infusers...they all do the same basic thing--deliver insulin. These items carry insulin through the outermost layer of skin and into fatty tissue so it can be used by the body. This section will also cover injection aids, products designed to make infecting easier.

Infusión subcutánea contínua de insulina: un cambio hacia el control metabólico óptimo / Continuous subcutaneous infusion of insulin: a change toward the optimal metabolic control

Gracias a los avances recientes en la investigación científica se ha logrado dilucidar gran cantidad de mecanismos moleculares que explican la fisiopatología de muchas enfermdades. Dichos avances han beneficiado también a la diabetología, haciendo posible el desarrollo de múltiples terapias que tienen por objetivo alcanzar un control metabólico óptimo que posibilite una disminución significativa de la morbimortalidad derivada de las complicaciones crónicas. La infusión subcutánea contínua de insulina ha demostrado, a lo largo de 25, años ser un método eficaz para mejorar el control metabólico cuando se indica en el paciente adecuado. Su utilización ha crecido en forma importante en los últimos años y actualmente constituye una alternativa para el tratamiento intensificado de la diabetes mellitus.

New insulin replacement technologies: overcoming barriers to tight glycemic control.

New insulin analogues act more quickly, allowing better postprandial glycemic control and making intensive control easier. New methods of delivering insulin, notably inhaled insulin, will soon provide alternatives to painful injections. Improved glucose sensors may eventually make an artificial pancreas possible.