Search

The effectiveness of a hybrid closed-loop (HCL) system in improving glycemic control is unclear in Japanese individuals. Therefore, we assessed the effect impact of the MiniMed 770G HCL system on glycemic control in this population. This prospective, single-center, 24-week observational study (registration number: UMIN000047394) enrolled 23 individuals with type 1 diabetes mellitus using the Medtronic MiniMed 640G system. The primary endpoint was the improvement in time in the range of 70–180 mg/dL after transitioning to the MiniMed 770G HCL system. We observed an increase in time in range (from 64.1 [55.8–69.5] to 70.9 [67.1–74.4] %, interquartile range 25–75%, p < 0.001) and a decrease in glycated hemoglobin level (from 7.4 [7.0–7.9] to 7.1 [6.8–7.4] %, p = 0.003). There was a significant reduction in time above the range (181–250 mg/dL: 25.8 [20.9–28.6] to 19.5 [17.1–22.1] %, p < 0.001; >251 mg/dL: 8.7 [4.0–13.0] to 4.7 [3.6–9.1] %, p < 0.001). Time below the range remained unchanged (54–69 mg/dL: 1.8 [0.4–2.4] to 2.1 [0.4–3.9] %, p = 0.24;

IntroductionInsulin Infusion Sets (IIS) play a crucial role in ensuring the safe delivery of insulin through a Continuous Subcutaneous Insulin Infusion (CSII) for individuals with Type 1 Diabetes (T1D). Recent advancements in therapy have highlighted the need to address issues such as unexplained hyperglycemia and IIS occlusion.ObjectiveTo investigate the adverse events (AEs) associated with IIS that impact the treatment of T1D, with a specific focus on promoting effective educational practices.MethodsOne hundred and eighteen patients under treatment at the Diabetes Center Insulin Pump Ambulatory, Federal University of São Paulo responded to a semi-structured questionnaire. Over 6 months, a nurse researcher interviewed them via video calls.ResultsCatheter-related adverse events (AEs) included catheter knots, folding, and accidental traction. AEs associated with cannula use were mainly related to cannula fixation adhesive, insulin leakage, bleeding episodes, and skin problems. The cannula patch tends to detach easily in hot conditions or when used for more than 3 days, leading to local itching. Adhesive glue can cause redness and pain. Insulin leakage typically occurs after the catheter disconnects from the cannula, accidental cannula traction, or beneath the cannula patch. Bleeding has been reported inside the cannula or at the insertion site, resulting in local pain and, in some cases, obstruction of insulin flow. When accidental cannula traction occurs, it is recommended to replace the entire IIS system. In situations involving bleeding, leakage, insulin odor, or unsuccessful attempts to correct hyperglycemic episodes with a “bolus” of insulin, it is advisable to change the IIS system and evaluate appropriate techniques for handling and infusing the device. Moreover, regular inspections of the device and reservoir/cartridge are essential.ConclusionSerious AEs can occur even in cases where the occlusion alarm is not activated, leading to interruptions in insulin flow. Conversely, in less severe situations, alarm activation can occur even in the absence of insulin flow interruption. Accidental catheter traction and catheter bending are commonly encountered in everyday situations, while issues related to the cannula directly affect blood glucose levels. AEs related to the IIS cannula often involve insulin leakage into the skin, bleeding, and skin events attributed to adhesive issues with the cannula.

Aim: Use of the MiniMed 780G system (MM780G) can result in a reduction in mean and standard deviation (SD) of sensor glucose (SG) values. We assessed the significance of the coefficient of variation (CV) as a measure of hypoglycaemia risk and glycaemic control. Materials and Methods: Data from 10 404 MM780G users were analysed using multivariable logistic regression to assess the contribution of CV to (a) hypoglycaemia risk, measured as not reaching target <1% for time below range (TBR), and (b) achieving targets of time‐in‐range (TIR) >70% and glucose management indicator <7%. CV was compared with SD and low blood glucose index. To assess the relevance of CV <36% as a therapeutic threshold, we identified the CV cut‐off point that optimally discriminated users at risk of hypoglycaemia. Results: The contribution of CV was the smallest in terms of risk of hypoglycaemia (vs. low blood glucose index and SD) and TIR and glucose management indicator targets (vs. SD). In all cases the models with SD showed the best fit. A CV <43.4% (95% CI: 42.9–43.9) was the optimal cut‐off point with a correct classification rate of 87.2% (vs. 72.9% for CV <36%). Conclusion: For MM780G users, CV is a poor marker for hypoglycaemia risk and glycaemic control. We recommend using, for the former, TBR and whether the TBR target is met (and not using CV <36% as a therapeutic threshold for hypoglycaemia); for the latter, TIR, time above range, whether targets are met and a discrete description of mean SG and SD of SG values. [ABSTRACT FROM AUTHOR]

Few studies have been conducted among Asian children and adolescents with type 1 diabetes mellitus (T1DM) using do-it-yourself artificial pancreas system (DIY-APS). We evaluated real-world data of pediatric T1DM patients using DIY-APS. Data were obtained for 10 patients using a DIY-APS with algorithms. We collected sensor glucose and insulin delivery data from each participant for a period of 4 weeks. Average glycosylated hemoglobin was 6.2%±0.3%. The mean percentage of time that glucose level remained in the target range of 70 to 180 mg/dL was 82.4%±7.8%. Other parameters including time above range, time below range and mean glucose were also within the recommended level, similar to previous commercial and DIY-APS studies. However, despite meeting the target range, unadjusted gaps were still observed between the median basal setting and temporary basal insulin, which should be handled by healthcare providers.

ABSTRACT Objective: To develop, adapt and validate an instrument named “CSII – Brazil” to assess users’ conceptual and procedural knowledge of continuous subcutaneous insulin infusion systems. Materials and methods: Methodological and exploratory study developed in three stages: a) instrument development; b) content validation and cultural adaptation (evaluation by a committee of experts and pre-test with CSII users); c) psychometric validation through instrument application in a sample of 60 patients by means of the web tool e-Surv. Internal consistency and reproducibility analyses were performed within IBM SPSS Statistics 20 programming environment. Results: The 16 multiple-choice question instrument successfully attained a content validity index of 0.97, showing satisfactory internal consistency, with 0.61 Cronbach's alpha [95% CI 0.462-0.746] and an intraclass correlation coefficient of 0.869 [95% CI: 0.789-0.919] between the test and retest scores. Conclusion: The CSII – Brazil instrument is considered adequate and validated to assess continuous subcutaneous infusion system users’ conceptual and procedural knowledge.

Purpose Despite the prevalent use of insulin pump therapy worldwide, few studies have been conducted among young patients with type 1 diabetes (T1D) in Korea. We investigated the durability and effectiveness of insulin pump therapy among Korean pediatric and young adult patients with T1D. Methods This study included 54 patients with T1D diagnosed at pediatric ages (range, 1.1–14.1 years) who initiated insulin pump therapy during 2016–2019 at Seoul National University Children's Hospital and Seoul National University Bundang Hospital. Clinical and biochemical data, including anthropometric measurements, insulin dose, and glycated hemoglobin (HbA1c) levels were obtained from T1D diagnosis to last follow-up. Results Forty-four patients (81.5%) continued insulin pump therapy with a median pump use duration of 2.9 years (range, 0.2–3.5 years); 10 discontinued the therapy within 12 months (

BACKGROUND: According to different studies, diabetes mellitus type 2 (DM2) is associated with higher mortality after undergoing coronary artery bypass grafting (CABG). Perioperative hyperglycaemia, even in non-DM2 patients, is associated with adverse outcomes after CABG. Thus, successful perioperative blood glucose control (BGC) is mandatory to reduce the risk of death and postoperative complications. Nowadays, the most effective method for BGC in the operating room is still unknown. AIMS: To assess the continuous glucose monitoring (CGM) efficacy in association with insulin pump therapy in patients with coronary artery disease (CAD) and DM2 undergoing CABG in intra- and early postoperative periods. METHODS: The study involved 97 patients undergoing isolated CABG. Patients were divided into two groups: 48 patients with DM2 and 49 patients without DM2. In both groups of patients, we used CGM in intra- and early postoperative periods (72 hours). In some patients with DM2, CGM was associated with insulin pump therapy (MiniMed Paradigm Veo 554/754) to successfully control postoperative glucose level. Besides commonly used tests (such as HbA1C and lipid profile), we analysed high sensitive C-reactive protein (hs-CRP) levels before surgery, and then at 1 hour, 12 hours and 7 days after CABG in order to estimate their prognostic value. RESULTS: During the 48 hours after CABG, there was a trend towards having higher glucose levels in both groups of patients with and without DM2 according to CGM. In patients with DM2, the glucose level was significantly increased (р

Despite using sensor-augmented pump therapy (SAPT) with predictive low-glucose management (PLGM), hypoglycemia is still an issue in patients with type 1 Diabetes (T1D). Our aim was to determine factors associated with clinically significant hypoglycemia (<54 mg/dl) in persons with T1D treated with PLGM-SAPT. ology: This is a multicentric prospective real-life study performed in Colombia, Chile and Spain. Patients with T1D treated with PLGM-SAPT, using sensor ≥70% of time, were included. Data regarding pump and sensor use patterns and carbohydrate intake from 28 consecutive days were collected. A bivariate and multivariate Poisson regression analysis was carried out, to evaluate the association between the number of events of <54 mg/dl with the clinical variables and patterns of sensor and pump use. 188 subjects were included (41 ± 13.8 years-old, 23 ± 12 years disease duration, A1c 7.2% ± 0.9). The median of events <54 mg/dl was four events/patient/month (IQR 1–10), 77% of these events occurred during day time. Multivariate analysis showed that the number of events of hypoglycemia were higher in patients with previous severe hypoglycemia (IRR1.38; 95% CI 1.19–1.61; p < 0.001), high glycemic variability defined as Coefficient of Variation (CV%) > 36% (IRR 2.09; 95%CI 1.79–2.45; p < 0.001) and hypoglycemia unawareness. A protector effect was identified for adequate sensor calibration (IRR 0.77; 95%CI 0.66–0.90; p:0.001), and the use of bolus wizard >60% (IRR 0.74; 95%CI 0.58–0.95; p:0.017). In spite of using advanced SAPT, clinically significant hypoglycemia is still a non-negligible risk. Only the identification and intervention of modifiable factors could help to prevent and reduce hypoglycemia in clinical practice. • Despite the use of advance sensor augmented pump therapy (SAPT), hypoglycemia remains a problem in type 1 diabetes. • High glycemic variability, previous severe and unawareness hypoglycemia, were associated with hypoglycemic events. • The intervention of factors such as sensor calibration and the use of bolus wizard could help to prevent hypoglycemia. • This is the first multicenter study that describes variables associated with hypoglycemia in patients treated with SAPT. [ABSTRACT FROM AUTHOR]

Background: Automated insulin delivery with predictive low glucose suspend (PLGS) feature has the potential to reduce risk of hypoglycemia in patients with type 1 diabetes mellitus (T1DM). We aim to systematically synthesize the evidence on the efficacy and safety of PLGS in children and adolescents with T1DM. Methods: We performed a systematic search through Ovid/MEDLINE, Ovid/Embase, and other search engines. We included randomized controlled trials (RCTs) evaluating the effect of sensor augmented pump (SAP) with PLGS feature compared to SAP or insulin pump therapy without SAP in decreasing hypoglycemia in children and adolescents aged 2 to 18 years with T1DM, with at least 2 weeks of follow‐up. Two reviewers independently selected studies, extracted data, and evaluated the risk of bias (ROB). Results: Five RCTs with total sample size of 493 children aged 6 to 18 years met the inclusion criteria. The overall ROB of included studies was low. There is high quality evidence that PLGS is superior to SAP in decreasing time spent in hypoglycemia (sensor glucose [SG] <3.9 mmol/L [<70 mg/dL]/24 h) and nocturnal hypoglycemia (SG <3.9 mmol [<70 mg/dL]/L/night) with an absolute mean difference of 17.4 min/d (95% CI: −19.2, –15.5) and 26.3 min/night (95% CI: −35.5, −16.7), respectively, without increasing percentage of time spent in hyperglycemia or episodes of diabetic ketoacidosis (DKA). There was insufficient evidence for the impact of PLGS on health related quality of life (HRQL). Conclusions: PLGS is superior to SAP in decreasing daytime and nocturnal hypoglycemia without increasing the risk of DKA or hyperglycemia. Future studies should address the impact of PLGS on children younger than 6‐years‐old and HRQL. [ABSTRACT FROM AUTHOR]

This paper describes the development and simulation of an algorithm for the automatic control of insulin infusion, in the glycemic management of patients with diabetic ketoacidosis (CAD) and hyperglycemic hyperosmolar state (EHH). An algorithm was programmed to calculate the requirement insulin for a glycemic decrease of 50 mg/dL/h until reach 250 mg/dL in blood glucose levels, and thus maintaining it at 220 mg/dL until the pathology remission. The software simulation was performed using glycemic records of 10 patients with CAD managed in the Hospital Juárez de México. The results of the simulation showed a lower incidence of hypoglycemia, as well as a lower insulin requirement within the treatment, without differences in the average glucose decreases per hour between real and simulated measurements. This software proposes an innovative use of the artificial pancreas in hyperglycemic emergencies, and also implementing the use of insulin sensitivity as a variable for their function. The results show that the algorithm could be able to achieve glycemic management attached to the treatment guidelines, generating lower insulin expenditure and avoiding hypoglycemia during therapy, with a possible application in autonomous biomedical devices. [ABSTRACT FROM AUTHOR]

Aim: To determine patient/carer expectations of continuous glucose monitoring (CGM) and short-term satisfaction, to assess the efficacy of CGM in improving: fear of hypoglycaemia and glycaemic control (HbA1c , ketosis, hypoglycaemia) and to determine time requirements of diabetes clinic staff in commencing and administering CGM.Methods: We assessed CGM-naïve patients starting on CGM at a Sydney Diabetes Centre following the introduction of a nationwide government subsidy for CGM. A standardised questionnaire was administered collecting demographic and glycaemic information in addition to Likert scale assessment of expectations and satisfaction. Clinic staff reported time dedicated to CGM education, commencement and follow-up.Results: A total of 55 patients or parents/carers completed baseline questionnaires, with 37 completing a 3-month follow-up questionnaire. There were high expectations of CGM prior to commencement and high satisfaction ratings on follow-up. CGM improved fear of hypoglycaemia, and total daily insulin dose increased after commencement of CGM. There was a trend towards lower HbA1c that was not statistically significant and no statistically significant reduction in ketosis or hypoglycaemia. Comments were mostly positive, with some concern raised regarding technical issues and a lack of subsidy after 21 years of age. Staff time requirements were substantial, with an estimated average of 7.7 h per patient per year.Conclusions: Patients and families have high expectations of CGM, and satisfaction levels are high in the short term. Total insulin delivery increased after CGM commencement. Time requirements by staff are substantial but are worthwhile if families' overall satisfaction levels are high. [ABSTRACT FROM AUTHOR]

Type 1 diabetes mellitus has witnessed significant progress in its management over the past several decades. This review highlights technologic advancements in type 1 diabetes management. Continuous glucose monitoring systems are now available at various functionality and cost levels, addressing diverse patient needs, including a recently US Food and Drug Administration (FDA)--approved implantable continuous glucose monitoring system (CGMS). Another dimension to these state-of-the-art technologies is CGMS and insulin pump integration. These integrations have allowed for CGMS-based adjustments to basal insulin delivery rates and suspension of insulin delivery when a low blood glucose event is predicted. This review also includes a brief discussion of upcoming technologies such as patch-based CGMS and insulinglucagon dual-hormonal delivery. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Healthcare professional ( HCP) time supporting insulin pump therapy ( IPT) has not been documented, yet it is important in planning and allocating resources for effective care. Aim This study aims to determine HCP time spent in IPT patient care to inform resource planning for optimal IPT delivery. Methods Twenty-four Australian adult IPT-experienced institutions (14 government funded, seven private, three both) collected data between April 2012 and January 2013 prospectively, including: patient demographics, HCP classification, purpose of HCP-patient interaction, interaction mode and HCP time with the patient. A subset of patients was tracked from pre-pump education until stable on IPT. Results Data on 2577 HCP-adult patient interactions (62% face-to-face, 29% remote, 9% administrative) were collected over 12.2 ± 6.4 weeks for 895 patients; age 35.4 ± 14.2 years; 67% female; 99% type 1 diabetes, representing 25% of all IPT patients of the institutions. Time (hours) spent on IPT interactions per centre per week were: nurses 5.4 ± 2.8, dietitians 0.4 ± 0.2 and doctors 1.0 ± 0.5. IPT starts accounted for 48% of IPT interaction time. The percentage of available diabetes clinic time spent on outpatient IPT interactions was 20.4%, 4.6% and 2.7% for nurses, dietitians and doctors respectively. Fifteen patients tracked from pre-pump to stabilisation over 11.8 ± 4.5 weeks, required a median (range) of 9.2 (3.0-20.9), 2.4 (0.5-6.0) and 1.8 (0.5-5.4) hours per patient from nurses, dietitians and doctors respectively. Conclusions IPT patient care represents a substantial investment in HCP time, particularly for nurses. Funding models for IPT care need urgent review to ensure this now mainstream therapy integrates well into healthcare resources. [ABSTRACT FROM AUTHOR]

This study describes how adults with type 1 diabetes experience the transition from multiple daily injections (MDI) to continuous subcutaneous insulin infusion (CSII or 'insulin pump'). The study is based on interviews in focus groups, with 11 persons with type 1 diabetes who had had CSII for at least one year, which were analysed using qualitative content analysis. The analysis resulted in three categories: life and health; involvement of others; and technology dependence. Participants' experiences are summarised in the theme 'CSII is perceived as liberating, but also implies a sense of the diabetes made visible'. The transition resulted in changed life and health with greater freedom and flexibility, particularly in meal situations. The participants felt that their blood glucose was easier to control. Those around them reacted with curiosity, but some participants felt compelled to tell others that they had diabetes since the pump could be seen or heard. The participants found that coping with CSII in daily life was easier and more comfortable than they had expected. However, having to constantly be prepared for technical failure was experienced as cumbersome. All participants indicated that they were satisfied with their treatment and recommended it to others. Transition to CSII may be experienced as liberating, but might also imply a sense of the diabetes made visible. The results can be used in clinical practice, when advising about CSII. Being aware of both positive and negative experiences with CSII can contribute to better care for those already being treated with CSII. Eur Diabetes Nursing 2014; 11(2): 38-42 [ABSTRACT FROM AUTHOR]

Diabetes during infancy is uncommon and continuous subcutaneous insulin infusion (CSII) is the recommended treatment with such young children. However, this form of treatment has not been investigated previously from the perspective of the parents. The aim of this study was to determine parents' experiences of caring for a child less than two years old who had diabetes mellitus and was being treated with CSII therapy. Three pairs of parents were interviewed twice to elucidate their views on the initial period and on daily living. Data were submitted to qualitative content analysis and resulted in seven categories and one theme, the latter being: 'The diabetes disease was threatening our baby's life, but then the insulin pump came as a rescuing, though challenging, angel'. Parents initially felt life had been turned upside down, but later they felt in control nearly all the time. It was concluded that parents of infants with diabetes are in great need of support in order to manage the disease and CSII technology. The fear of losing control and the lack of relief lead to social isolation. Educating someone close to the family could be a valuable intervention. [ABSTRACT FROM AUTHOR]

Purpose: To assess the impact of a computer-generated blood glucose (BG) alert, generated by a Patient Data Management System (PDMS) and superimposed on a paper-based guideline, on tight glycemic control (TGC) in the intensive care unit (ICU). Methods: TGC in the Leuven University Hospitals is performed by nurses using a paper-based guideline that allows anticipative, intuitive decision-making. An electronic alert was implemented on 1 August 2007 in which a pop-up appears in the PDMS at the following BG thresholds: >180, >110, 60-80, 40-60 and <40 mg/dl. The impact of this electronic alert was assessed by a sequential cohort study: the mean BG, the glycemic penalty index (GPI), the hyperglycemic index (HGI), the number of hypoglycemic events, the standard deviation (SD) of the BG time series and the number of BG measurements were compared in all adults admitted 6 months before ('pre-alert group', n = 729) and after ('alert group', n = 644) the implementation of the electronic alert. Results: The alert resulted in a reduction of mean BG (112 vs. 110 mg/dl, p = 0.002), GPI (20 vs. 19, p = 0.029) and HGI (10 vs. 9 mg/dl, p = 0.004), without increasing BG sampling (median 25 measurements/patient in both groups, p = 0.776). The alert reduced the proportion of patients experiencing an episode of hypoglycemia from 6.5 to 4.0% ( p = 0.043). The SD of the BG time series was not affected (28 mg/dl in both groups, p = 0.566). Conclusion: A computer-generated alert was able to statistically significantly improve the quality of TGC in ICU patients without increasing the need for blood sampling. [ABSTRACT FROM AUTHOR]

The article offers information on the technologies used in the management of diabetes in children. It looks at the increased utilization of continuous subcutaneous insulin infusions (insulin pumps) and continuous glucose monitoring systems (CGMS) among children with type 1 diabetes mellitus. The disadvantages of insulin pumps and CGMS are highlighted. A chart comparing four CGMS for diabetes is also presented.

A simulation model of the glucose-insulin system in the postprandial state can be useful in several circumstances, including testing of glucose sensors, insulin infusion algorithms and decision support systems for diabetes. Here, we present a new simulation model in normal humans that describes the physiological events that occur after a meal, by employing the quantitative knowledge that has become available in recent years. Model parameters were set to fit the mean data of a large normal subject database that underwent a triple tracer meal protocol which provided quasi-model-independent estimates of major glucose and insulin fluxes, e.g., meal rate of appearance, endogenous glucose production, utilization of glucose, insulin secretion. By decomposing the system into sub-systems, we have developed parametric models of each subsystem by using a forcing function strategy. Model results are shown in describing both a single meal and normal daily life (breakfast, lunch, dinner) in normal. The same strategy is also applied on a smaller database for extending the model to type 2 diabetes. [ABSTRACT FROM AUTHOR]

Background: INCA (Intelligent Control Assistant for Diabetes) is a project funded by the EU with the objective to improve diabetes therapy by creating a personal closed loop system interacting with telemedical remote control. Cost-benefit analyses of such systems are needed to decide on the introduction of telemedical systems such as the INCA system to routine care. Objective: To identify and apply suitable methods for a cost-benefit analysis from the perspective of the payor for health services (i.e. a health insurance company). Methods: For the cost analysis MOSAIK-M was used, a method and tool that supports health information systems analysis and design. Two MOSAIK-M models were created during the INCA project. Both, the “As is”-model of conventional insulin pump based diabetes care, and the “To be”-model of the INCA system were parameterised with cost values. With both models a period of one year was simulated to determine the yearly costs of diabetes management and treatment for a patient who does not suffer from diabetes related complications yet. The HbA1c-value was chosen as effectiveness parameter for diabetes therapy. To determine the probability of developing complications and their probable duration the Archimedes-Model was used. It was parameterised with selected HbA1c-values anticipating the effect of INCA. The simulation results in form of years of disease within a 30-years time frame were multiplied with corresponding treatment costs from the KoDiM study. Results: The yearly costs of conventional insulin pump treatment for a 19 year old diabetes type 1 patient with no complications are 5,907 euro (German health care system). Using the INCA system would raise the yearly costs by 7,348 euro. Almost all (98.53%) of the additional costs are generated by the continuous blood glucose measurement device. HbA1c-decreases from 7% (conventional treatment) to 6.5%, 6%, and 5.8 % would produce yearly savings (benefit) concerning the treatment of complications of 100.50 euro, 189.20 euro and 221.82 euro. Conclusions: The selected approach produces an estimation of a lower bound for cost savings. Further work is needed to improve the approximation and to include indirect and intangible costs. The INCA approach would be cost efficient from the chosen perspective, only if the costs of system operation were notably lowered. [ABSTRACT FROM AUTHOR]

Insulin pumps for children with type 1 diabetes have been broadly adopted despite equivocal evidence about comparative effectiveness. To understand why and inform policy related to public funding for new technologies, we explored how physicians interpret the value of pumps. We conducted open-ended, semi-structured interviews with 16 physicians from a pediatric diabetes network in Ontario, Canada, and analyzed the data using interpretive description. Respondents recognized that pumps fell short of expectations because they required hard work, as well as family and school support. Yet, pumps were valued for their status as new technologies and as a promising step in developing future technology. In addition, they were valued for their role within a therapeutic relationship, given the context of chronic childhood disease. These findings identify the types of beliefs that influence the adoption and diffusion of technologies. Some beliefs bear on hopes for new technology that may inappropriately hasten adoption, creating excess cost with little benefit. On the other hand, some beliefs identify potential benefits that are not captured in effectiveness studies, but may warrant consideration in resource allocation decisions. Still others suggest the need for remediation, such as those bearing on disparity in pump use by socioeconomic status. Understanding how technologies are valued can help stakeholders decide how to address such beliefs and expectations in funding decisions and implementation protocols., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Although physical exercise (PE) is recommended for individuals with type 1 diabetes (DM1), participation in exercise is challenging because it increases the risk of severe hypoglycemia and the available therapeutic options to prevent it frequently result in hyperglycemia. There is no clear recommendation about the best timing for exercise. The aim of this study was to compare the risk of hypoglycemia after morning or afternoon exercise sessions up to 36 hours postworkout., Methods: This randomized crossover study enrolled subjects with DM1, older than 18 years of age, on sensor-augmented insulin pump (SAP) therapy. Participants underwent 2 moderate-intensity exercise sessions; 1 in the morning and 1 in the afternoon, separated by a 7 to 14 day wash-out period. Continuous glucose monitoring (CGM) data were collected 24 hours before, during and 36 hours after each session., Results: Thirty-five subjects (mean age 30.31 ± 12.66 years) participated in the study. The rate of hypoglycemia was significantly lower following morning versus afternoon exercise sessions (5.6 vs 10.7 events per patient, incidence rate ratio, 0.52; 95% CI, 0.43-0.63; P < .0001). Most hypoglycemic events occurred 15-24 hours after the session. On days following morning exercise sessions, there were 20% more CGM readings in near-euglycemic range (70-200 mg/dL) than on days prior to morning exercise (P = .003)., Conclusions: Morning exercise confers a lower risk of late-onset hypoglycemia than afternoon exercise and improves metabolic control on the subsequent day., (© 2015 Diabetes Technology Society.)

Abstract: Objectives: INCA (Intelligent Control Assistant for Diabetes) is an EU funded project aimed at improving diabetes therapy by creating a personal closed-loop system interacting with telemedical remote control. This study aims at identifying and applying suitable methods for a cost–benefit analysis from the perspective of the payor for health services. Methods: For cost analysis MOSAIK-M was used, a method and tool for health information systems analysis and design. Two MOSAIK-M models were created describing conventional insulin pump based diabetes care (CSII), and INCA based diabetes care. Both models were parameterised with costs and simulated to determine yearly costs of diabetes management and treatment for a patient with no diabetes related complications. Probability of developing complications and their duration were determined based on the Archimedes model. It was parameterised with results of a clinical study concerning HbA1c-value changes using the INCA system compared with conventional CSII. The simulation results in form of years of disease within a 30-year time frame were multiplied with corresponding treatment costs. Results: Yearly costs of conventional insulin CSII for a diabetes type 1 patient are €5908 (German health care system). Using INCA based on the clinical study setting would raise yearly costs by €2233. 24% of the INCA costs are generated by the continuous blood glucose measurement device, 5% by IT devices and services. Considering also diabetes related complications in a 30-year time frame and HbA1c value reductions from 7.9 and 7.6% (conventional CSII) to 7.5 and 7.3% (INCA) reduces the additional costs of INCA to €2102 and €2162. Conclusions: The approach produces an estimation of a lower bound for cost savings concerning the treatment of diabetes related complications in a 30-year time frame. These savings alone do not prove cost efficiency of the INCA approach. Further work is needed to improve the approximation and to include indirect and intangible costs. [Copyright &y& Elsevier]

Background: Insulin pump therapy may be offered to patients with type 2 diabetes that is not controlled by multiple daily injections. Patients with type 2 diabetes may suffer from unrecognized cognitive disabilities, which may compromise the use of a pump device., Methods: To predict patient autonomy, we evaluated 39 patients with type 2 diabetes from our database (n = 143) after continuous subcutaneous insulin infusion (CSII) initiation using (1) an autonomy questionnaire evaluating the patient's cognitive and operative capacities for CSII utilization, (2) the Montreal Cognitive Assessment (MOCA) for the detection of mild cognitive disabilities, (3) the Hospital Anxiety and Depression Scale (HADS) for the detection of anxiety and depression, and (4) the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Patients were selected to constitute 3 groups matched for age, with different degrees of autonomy at discharge after the initial training program: complete (n = 13), partial (n = 13), or no autonomy (n = 13)., Results: The satisfaction level with the pump device was high. At the last follow-up visit, only 23% of patients did not reach complete autonomy. The autonomy score correlated fairly with the MOCA score (R = 0.771, P < .001). A receiver operating characteristic (ROC) analysis showed that at a cut-off score of 24, the MOCA identified autonomous versus dependent patients at long-term follow-up (area under the ROC curve [AUC], 0.893; sensitivity, 81%; specificity, 81%). The HADS correlated negatively with the autonomy score, and the sociocultural level also influenced autonomy with pump utilization., Conclusion: Patients with type 2 diabetes with partial autonomy at discharge may progress to complete autonomy. The MOCA and HADS may help predict a patient's ability to manage with a pump device., (© 2014 Diabetes Technology Society.)

Background: A simulation model of the glucose-insulin system in normal life conditions can be very useful in diabetes research, e.g., testing insulin infusion algorithms and decision support systems and assessing glucose sensor performance and patient and student training. A new meal simulation model has been proposed that incorporates state-of-the-art quantitative knowledge on glucose metabolism and its control by insulin at both organ/tissue and whole-body levels. This article presents the interactive simulation software GIM (glucose insulin model), which implements this model., Methods: The model is implemented in MATLAB, version 7.0.1, and is designed with a windows interface that allows the user to easily simulate a 24-hour daily life of a normal, type 2, or type 1 diabetic subject. A Simulink version is also available. Three meals a day are considered. Both open- and closed-loop controls are available for simulating a type 1 diabetic subject., Results: Software options are described in detail. Case studies are presented to illustrate the potential of the software, e.g., compare a normal subject vs an insulin-resistant subject or open-loop vs closed-loop insulin infusion in type 1 diabetes treatment., Conclusions: User-friendly software that implements a state-of-the-art physiological model of the glucose-insulin system during a meal has been presented. The GIM graphical interface makes its use extremely easy for investigators without specific expertise in modeling.