Uso do sistema de infusão contínua de insulina em crianças e adolescentes com diabetes mellitus tipo 1: revisão de mapeamento sistemático / Use of continuous insulin infusion systems in children and adolescents with type 1 diabetes mellitus

Um dos avanços tecnológicos no tratamento do diabetes mellitus tipo 1 (DM1) é o uso do sistema de Infusão Contínua de Insulina (SICI). Essa revisão sistemática de mapeamento teve como objetivo agrupar e descrever as evidências dos estudos relacionados ao uso do SICI em crianças e adolescentes com DM1. A estratégia de busca foi estruturada a partir da ferramenta PCO, utilizando-se uma combinação de descritores e palavras-chaves. Buscas bibliográficas foram conduzidas nas seguintes bases de dados: PubMed, Embase, CINAHL, Lilacs e PsycINFO, aplicando-se um único filtro, que foi o temporal, delimitando-se a publicação dos estudos até dezembro de 2020. Os critérios de inclusão foram: estudos primários e secundários, quantitativos e qualitativos, que tivessem como objetivo abordar o uso do SICI em crianças e adolescentes (0-18 anos) com DM1; e estudos que abordassem as perspectivas das próprias crianças e adolescentes, dos profissionais de saúde e dos familiares. Constituíram critérios de exclusão: estudos que comparassem a terapia de múltiplas injeções de insulina com a terapia por meio do SICI ou que incluíssem adultos jovens e adultos conjuntamente às crianças e adolescentes, participantes com diabetes mellitus tipo 2 (DM2) ou usuários do SICI com foco no sistema de monitorização contínua de glicose (CGM) ou pâncreas artificial. Utilizou-se o software Rayyan para exclusão das referências duplicadas e para a triagem dos títulos e resumos das referências capturadas, a qual foi conduzida por dois revisores independentes. Os dados dos estudos incluídos foram analisados com auxílio de uma ferramenta de extração adaptada e validada por pesquisadores especialistas em diabetes e com experiência no desenvolvimento de métodos de síntese de conhecimento. Os resultados foram analisados segundo a técnica de análise de conteúdo. Incluiu-se um total de 113 estudos na revisão, dentre eles, estudos originais, revisões de literatura e publicações de literatura cinzenta. Mapas de geocodificação dos estudos foram produzidos com auxílio do software ArcGis 10.5 para ilustrar o local de desenvolvimento dos estudos. A análise geográfica dos estudos possibilitou identificar maior concentração de publicações conduzidas em países desenvolvidos. Esta revisão reuniu as evidências para o uso do SICI em crianças e adolescentes com DM1, as quais foram apresentadas por meio das seguintes categorias: indicações e contraindicações para o uso do SICI; controle metabólico; redes de apoio; e benefícios e desafios do uso do SICI. As indicações para o uso do SICI superam as contraindicações. Apesar de grande parte dos estudos evidenciar melhora do controle metabólico de crianças e adolescentes em uso do SICI, a piora desse controle foi descrita em algumas pesquisas, o que sugere que esse parâmetro não deve ser analisado de forma isolada. As redes de apoio foram citadas como um dos fatores que influenciam os parâmetros de controle metabólico, conformando as subcategorias: apoio familiar e apoio da equipe de saúde e escola. Foram elencados desafios para o uso do SICI na população pediátrica, porém, vale ressaltar que parte destes desafios tem sido superada com o avanço da ciência e da tecnologia moderna. Múltiplos benefícios também foram descritos na literatura, os quais podem auxiliar profissionais de saúde na tomada de decisão para a melhor escolha e acompanhamento do tratamento do DM1 em crianças e adolescentes. Esta revisão reúne evidências sobre o uso do SICI em crianças e adolescentes com DM1 e contribui com o corpo de conhecimento relacionado à temática

One of the technological advances in type 1 diabetes mellitus (T1DM) treatment is the use of Continuous Subcutaneous Insulin Infusion (CSII). The aim of this systematic mapping review was to group and describe the evidence from research on the use of CSII in children and adolescents with T1DM. The search strategy was structured based on the PCO tool, using a combination of descriptors and keywords. Bibliographic searches were undertaken in the following databases: PubMed, Embase, CINAHL, Lilacs and PsycINFO, applying a single time-based filter to delimit the publication of studies until December 2020. The inclusion criteria were: primary and secondary studies, quantitative and qualitative, aimed at discussing the use of CSII in children and adolescents (0-18 years) with T1DM; and studies addressing the perspectives of the actual children and adolescents, the health professionals and Family members. Exclusion criteria were: studies that compared multiple insulin injection therapy with therapy using CSII or that included young adults and adults together with the children and adolescents, participants with type 2 diabetes mellitus (T2DM), or with CSII users focusing on the continuous glucose monitoring (CGM) system or artificial pancreas. The software Rayyan was used to exclude duplicated references and to screen the titles and abstracts of the collected references, which was conducted by two independent reviewers. The data from the included studies were analyzed with the help of an extraction tool, adapted and validated by researchers with diabetes expertise and knowledgeable on the development of knowledge synthesis methods. The content analysis technique was used to analyze the results. In total, 113 studies were included in the review, covering original studies, literature reviews and grey literature publications. Geocoding maps of the studies were produced in ArcGis 10.5 to illustrate where the studies had been developed. Through the geographic analysis of the studies a greater concentration of publications in developed countries was identified. This review gathered evidence on the use of CSII in children and adolescents with T1DM, presented in the following categories: indications and contraindications for the use of CSII; metabolic control; support networks; and benefits and challenges of CSII use. The indications in favor of using CSII outweigh the contraindications. Although most of the studies evidence improved metabolic control in children and adolescents who use CSII, some studies described worse control, suggesting that this parameter should not be analyzed in isolation. The support networks were mentioned as one of the factors that influence the metabolic control parameters. This category includes the following subcategories: family support and support from the health team and school. Challenges were listed for the use of CSII in the pediatric population, although it should be highlighted that advanced science and modern technology have overcome some of these. Multiple benefits have also been described in the literature, which can help health professionals to make decisions in order to better choose and monitor T1DM treatment in children and adolescents. This review gathers evidence on the use of CSII in children and adolescents with T1DM and contributes to the body of knowledge on the theme

Factors associated with withdrawal from insulin pump therapy: A large-population-based study.

BACKGROUND: Although, number of diabetic patients received insulin pump (IP) therapy is increasing; there are limited data regarding factors associated with IP withdrawal. METHODS: We conducted a cross-sectional study using data from an Israeli health maintenance organization. All patients, 21 or older, with type 1 (T1DM) or type 2 (T2DM) diabetes, who received IP therapy for a 7-year period were identified. Patients who did not purchase IP maintenance supplies for at least six consecutive months were defined as withdrawn (N = 355). Patients who purchased supplies were defined as adherent (N = 352). RESULTS: In both T1DM and T2DM patients, withdrawal from IP therapy was positively associated with duration of diabetes longer than 5 years (odds ratio [OR] = 13.26 [CI, 7.16-23.34; P < .001] and OR = 10.92 [CI, 5.64-21.14; P < .001], respectively), nonadherence to dietician follow-up (OR = 5.78 [CI, 3.65-9.14; P < .001] and OR = 3.41 [CI, 1.99-5.85; P < .001], respectively), and poor glycaemic control prior to IP treatment (OR = 4.04 [CI, 2.18-7.48; P < .001] and OR = 4.59 [CI, 2.71-7.81; P < .001], respectively]. Co-morbid neuro-psychiatric disorders were also risk factors for IP withdrawal: diagnosis of depression (OR = 2.22 [CI, 1.16-4.27; P = .017] and Attention Deficit Hyperactivity Disorder (ADHD) OR = 2.45 [CI, 1.003-5.087; P = .043]) among T1DM patients; and diagnosis of depression (OR = 1.85 [CI, 1.05-5.27; P = .046] and dementia OR = 4.03 [CI, 1.03-19.77; P = .048]) among T2DM patients. CONCLUSION: In our large real-world population-based study, we found that smoking, obesity, poor glycaemic control, and co-morbid neuro-psychiatric disorders were associated with a high rate of withdrawal from IP therapy. Health care providers ought to familiarize themselves with patient characteristics predictive of nonadherence and should intensify patient follow-up when incorporating this new, costly, and challenging technology.

Prevalence and geographical distribution of insulin pump therapy in the Central Denmark Region and its association with metabolic parameters.

AIMS: Insulin treatment in type 1 diabetes encompasses multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII). Both population-based studies and comparative studies regarding CSII use are sparse. The aim of the current study was to describe the prevalence and distribution of CSII use among adults with type 1 diabetes in the Central Denmark Region and to compare metabolic control in CSII-treated patients to those treated with MDI. METHODS: A database was constructed using the Danish Adult Diabetes Registry in 2014/2015 in combination with an audit of the patients' medical records. RESULTS: 3909 adults with type 1 diabetes patients were included. The proportion of patients treated with CSII differed significantly between the 8 regional hospitals from 12.0% to 31.1%. CSII users had a significantly lower HbA1c compared to MDI treated patients (7.6% (60 mmol/mol) versus 8.0% (64 mmol/mol)) in unadjusted analyses. After adjustment for clinically relevant characteristics the difference between CSII and MDI-treated patients was attenuated, but remained statistically significant. CONCLUSION: The distribution of CSII differed markedly between hospitals and CSII users had better glycemic control, even after adjustment for sex, age, BMI, diabetes duration, smoking, use of lipid-lowering and blood pressure-lowering medication.

Comparative usability study of the dulaglutide single-use pen versus the insulin degludec FlexTouch® among self-injection-naïve patients with type 2 diabetes mellitus in Japan.

OBJECTIVE: This study assessed training time with the dulaglutide single-use pen (SUP) and the insulin degludec disposable prefilled pen (FlexTouch®) in self-injection-naïve patients with type 2 diabetes mellitus (T2DM) in Japan. METHODS: This multi-center, open-label, comparative, crossover study measured training time with the dulaglutide SUP vs FlexTouch®. Participants learned how to use both devices in a randomly assigned order. Healthcare providers (HCP) conducted the training. The primary end-point was the time required to train self-injection-naïve T2DM participants to self-inject correctly using each device. Secondary end-points included performance measures, such as success and error rates, patient perceptions related to ease-of-use, and factors associated with training time and performance. RESULTS: Overall, 48 participants were randomized and completed the study. The mean training time to achieve correct administration was significantly shorter with the dulaglutide SUP vs FlexTouch® (7.4 min vs 19.7 min, p < .001). The proportions of participants who successfully completed the mock injection without error were similar for both devices. Ninety-two percent (44/48) of participants reported that the dulaglutide SUP was easier to use than FlexTouch®. CONCLUSIONS: In this study, participants required a shorter training time to achieve correct administration with the dulaglutide SUP, and had a higher preference for the dulaglutide SUP, when compared to FlexTouch®. These data suggest that the dulaglutide SUP is easy-to-use, which may decrease the burden on HCPs to train diabetic patients how to administer injection therapy and reduce patient injection hurdles, such as needle fear.

Why is insulin pump treatment rarely used in adolescents and young adults with cystic fibrosis-related diabetes?

BACKGROUND: In type 1 diabetes (T1D), the use of continuous subcutaneous insulin infusion (CSII) has increased steadily in the last years. Compared with conventional insulin injection regimes, major advantages might be a nearly physiological insulin secretion, lower rates of hypoglycemia, higher flexibility in daily life, and increased quality of life. Data on CSII in cystic fibrosis-related diabetes (CFRD) are scarce. OBJECTIVE: To analyze current use of insulin pumps in CFRD and compare demographics of pump-treated patients between CFRD and T1D. METHODS: Data from the prospective German/Austrian diabetes patient registry on insulin-treated patients with either CFRD (n = 515) or T1D (n = 43 165) aged >10 yr at manifestation of diabetes were analyzed. RESULTS: A total of 4.1% (n = 21) of CFRD and 17.7% (n = 7647) of T1D patients received insulin pump treatment within the recent year of care (p < 0.001). Pump-treated patients with CFRD had a significantly shorter duration of diabetes [median (Q1 ; Q3 ): 5.8 (2.9; 9.5) vs. 7.8 (4.3; 20.4) yr, p = 0.026] and tended to be younger [22.0 (18.2; 30.1) vs. 24.9 (17.3; 45.9) yr] than pump-treated T1D patients. Age at initiation of CSII seemed to be lower in CFRD [19.2 (16.5; 29.2) vs. 23.3 (14.8; 43.5) yr]. Insulin pump therapy was used slightly more often in male CFRD patients than females (4.7 vs. 3.6%), whereas in T1D the opposite was observed (14.9 vs. 21.2%, p < 0.001). Discontinuation rate of CSII was higher in CFRD than T1D (30.0 vs. 12.7%, p = 0.005). CONCLUSIONS: Despite potential advantages, insulin pump therapy was rarely used among adolescent and young adult CFRD patients.

Position statement on efficiency of technologies for diabetes management.

Di@bet.es study results are impressive, showing that diabetes affects 13.8% of the Spanish population. Not only the statistical facts are alarming, but the increasing incidence of this disease is a major problem, as pandemic proportions of type 2 diabetes are expected. Thus, the study of diabetes represents a challenge not only for health services, but also for the Ministries of Health and Finance. Technology has become an essential tool in the quality are of patients with diabetes, as it helps in the healthcare processes to obtain an optimum metabolic balance and prevent possible complications. Insulin pumps, continuous glucose monitoring nd self-monitoring blood glucose have all proved their efficiency, and telemedicine it is making good progress. The indirect costs of diabetes in Spain are much higher than the directones, showing the importance of inverting the paradox. The optimization of resources depends not only on the ability of the physicians, but also the administration, to implant and sustain technological innovations in our system, and with that make it effective in terms of benefits. Cost-effectiveness and cost-utility analysis are needed to prioritize and allow health management services to make the correct choices for approaching this prevalent chronic disease.

Cystic fibrosis-related diabetes in adults: inpatient management of 121 patients during 410 admissions.

BACKGROUND: With improved longevity, cystic fibrosis (CF)-related diabetes (CFRD) has emerged as the most common nonpulmonary complication of CF. Patients with CFRD are frequently admitted to the hospital with infections and deterioration of pulmonary function, during which time glycemic control might have an impact on pulmonary function, recovery from infection, and survival. METHODS AND RESULTS: In an attempt to share our insight into inpatient management of CFRD, this article summarizes the experience of our inpatient glucose management team with hospital management of 121 adult CFRD patients who were hospitalized on 410 occasions at the University of Colorado Hospital between January 2009 and September 2011. This is a retrospective chart review descriptive study of inpatient management of CFRD in our center. Our cohort includes CFRD patients treated with basal and mealtime insulin through multiple daily injections or continuous subcutaneous insulin infusion (CSII), as well as patients receiving steroids or enteral nutrition, which adds complexity to the management of CFRD during hospitalization. CONCLUSIONS: Multiple hospitalizations and intensive inpatient management of CF are integral elements of treatment. Inpatient therapy for CFRD requires a customized approach that is uniquely different from that of type 1 or type 2 diabetes. Our experience highlights clinical circumstances such as irregular food intake, high dose steroid therapy, and supplemental tube feeding. For many patients, it is possible to continue CSII therapy during hospitalization through a combination of mutual trust between the patient and hospital staff and oversight provided by the glucose management team.

Guidelines for application of continuous subcutaneous insulin infusion (insulin pump) therapy in the perioperative period.

Case reports indicate that diabetes patients receiving outpatient insulin pump therapy have been allowed to continue treatment during surgical procedures. Although allowed during surgery, there is actually little information in the medical literature on how to manage patients receiving insulin pump therapy during a planned surgical procedure. A multidisciplinary work group reviewed current information regarding the use of insulin pumps in the perioperative period. Although the work group identified safety issues specific to surgical scenarios, it believed that with the use of standardized guidelines and a checklist, continuation of insulin pump therapy during the perioperative period is feasible. A sample set of protocols have been developed and are summarized. A policy outlining clear procedures should be established at the institutional level to guide physicians and other staff if the devices are to be employed during the perioperative period. Additional clinical experience with the technology in surgical scenarios is needed, and consensus should be developed for insulin pump use in the perioperative phases of care.

Glycemic control after coronary bypass graft: using intravenous insulin regulated by a computerized system.

Hyperglycemia is a risk factor for poor outcomes in patients who undergo coronary artery bypass grafting. Poor outcomes led a multidisciplinary team to formulate a protocol to improve glycemic control of inpatients who had diabetes or hyperglycemia. This protocol initiated an intravenous (i.v.) insulin infusion that is regulated by a computerized system that is known as a Glucommander, and guides the surgeon and nurses to an easy transition to subcutaneous insulin. As a result of implementing the computerized system which regulated i.v. insulin, glycemic control improved during surgery and postoperatively. Additionally, physician and nurse satisfaction increased because of better glycemic control using a reliable, safe, and easy tool for the management of insulin infusions and there were fewer interruptive phone calls to physicians.

Improving glycemic control in the cardiothoracic intensive care unit: clinical experience in two hospital settings.

OBJECTIVE: Recent studies suggest that strict perioperative glycemic control improves clinical outcomes after cardiothoracic surgery. However, optimal methods and targets for controlling blood glucose (BG) levels in this setting have not been established. Currently published intensive insulin infusion protocols (IIPs) have important practical limitations, which may affect their utility. In this article, the authors present their experience with a safe, effective, nurse-driven IIP, which was implemented simultaneously in 2 cardiothoracic intensive care units (CTICUs). DESIGN: Prospective cohort study. SETTING: Tertiary referral hospital and community teaching hospital. PARTICIPANTS: CTICU patients. INTERVENTIONS: A standardized, intensive IIP was used for all patients admitted to both CTICUs. Hourly BG levels, relevant baseline variables, and clinical interventions were collected prospectively from the active hospital chart and CTICU nursing records. MEASUREMENTS AND MAIN RESULTS: The IIP was used 137 times in 118 patients. The median time required to reach target BG levels (100-139 mg/dL) was 5 hours. Once BG levels decreased below 140 mg/dL, 58% of 2,242 subsequent hourly BG values fell within the narrow target range, 73% within a "clinically desirable" range of 80 to 139 mg/dL, and 94% within a "clinically acceptable" range of 80 to 199 mg/dL. Only 5 (0.2%) BG values were less than 60 mg/dL, with no associated adverse clinical events. CONCLUSIONS: The IIP safely and effectively improved glycemic control in 2 CTICUs, with minimal hypoglycemia. Based on prior studies showing the benefits of strict glycemic control, the implementation of this IIP should help to reduce morbidity and mortality in CTICU patients.