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1.
Internist (Berl) ; 61(1): 102-109, 2020 Jan.
Artigo em Alemão | MEDLINE | ID: mdl-31863132

RESUMO

The artificial pancreas (also referred to as closed-loop system) brings us one step closer to the decade-long dream of automated insulin delivery. The closed-loop system directs subcutaneous insulin delivery corresponding to the glucose concentration using a control algorithm. Evidence shows that closed-loop systems substantially improve glucose control and quality of life; however, fully automated closed-loop systems have not yet been accomplished. Active input from patients is required for mealtime insulin dosing and corrections. This article provides an overview on the current state of development of the artificial pancreas in the treatment of diabetes.


Assuntos
Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Insulina/uso terapêutico , Pâncreas Artificial , Algoritmos , Humanos , Hipoglicemia/prevenção & controle , Qualidade de Vida
3.
N Engl J Med ; 381(18): 1707-1717, 2019 10 31.
Artigo em Inglês | MEDLINE | ID: mdl-31618560

RESUMO

BACKGROUND: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes. METHODS: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.9 to 10.0 mmol per liter), as measured by continuous glucose monitoring. RESULTS: A total of 168 patients underwent randomization; 112 were assigned to the closed-loop group, and 56 were assigned to the control group. The age range of the patients was 14 to 71 years, and the glycated hemoglobin level ranged from 5.4 to 10.6%. All 168 patients completed the trial. The mean (±SD) percentage of time that the glucose level was within the target range increased in the closed-loop group from 61±17% at baseline to 71±12% during the 6 months and remained unchanged at 59±14% in the control group (mean adjusted difference, 11 percentage points; 95% confidence interval [CI], 9 to 14; P<0.001). The results with regard to the main secondary outcomes (percentage of time that the glucose level was >180 mg per deciliter, mean glucose level, glycated hemoglobin level, and percentage of time that the glucose level was <70 mg per deciliter or <54 mg per deciliter [3.0 mmol per liter]) all met the prespecified hierarchical criterion for significance, favoring the closed-loop system. The mean difference (closed loop minus control) in the percentage of time that the blood glucose level was lower than 70 mg per deciliter was -0.88 percentage points (95% CI, -1.19 to -0.57; P<0.001). The mean adjusted difference in glycated hemoglobin level after 6 months was -0.33 percentage points (95% CI, -0.53 to -0.13; P = 0.001). In the closed-loop group, the median percentage of time that the system was in closed-loop mode was 90% over 6 months. No serious hypoglycemic events occurred in either group; one episode of diabetic ketoacidosis occurred in the closed-loop group. CONCLUSIONS: In this 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases; iDCL ClinicalTrials.gov number, NCT03563313.).


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Pâncreas Artificial , Adolescente , Adulto , Idoso , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Desenho de Equipamento , Feminino , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Pâncreas Artificial/efeitos adversos , Adulto Jovem
4.
Expert Rev Med Devices ; 16(10): 845-853, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31540557

RESUMO

Introduction: Automated insulin delivery for people with type 1 diabetes has been a major goal in the diabetes technology field for many years. While a fully automated system has not yet been accomplished, the MiniMed™ 670G artificial pancreas (AP) system is the first commercially available insulin pump that automates basal insulin delivery, while still requiring user input for insulin boluses. Determining the safety and efficacy of this system is essential to the development of future devices striving for more automation. Areas Covered: This review will provide an overview of how the MiniMed 670G system works including its safety and efficacy, how it compares to similar devices, and anticipated future advances in diabetes technology currently under development. Expert Opinion: The ultimate goal of advanced diabetes technologies is to reduce the burden and amount of management required of patients with diabetes. In addition to reducing patient workload, achieving better glucose control and improving hemoglobin A1c (HbA1c) values are essential for reducing the threat of diabetes-related complications further down the road. Current devices come close to reaching these goals, but understanding the unmet needs of patients with diabetes will allow future technologies to achieve these goals more quickly.


Assuntos
Diabetes Mellitus Tipo 1/terapia , Pâncreas Artificial/efeitos adversos , Humanos , Sistemas de Infusão de Insulina , Vigilância de Produtos Comercializados , Resultado do Tratamento
5.
Internist (Berl) ; 60(9): 912-916, 2019 Sep.
Artigo em Alemão | MEDLINE | ID: mdl-31375851

RESUMO

Technological progress has led to numerous innovations in diagnostic and therapeutic applications in diabetes and will also improve the treatment of patients with diabetes in the future. The first commercially available hybrid closed-loop system has been available in the USA since 2016 and the next developmental step toward a fully automated artificial pancreas has been made. The automated control of the basal insulin secretion provides a stabilization of blood glucose with a reduction of hypoglycemia and improvement of long-term control as indicated by improved hemoglobin A1c levels. Although closed-loop systems are not yet officially available in Germany, patients with type 1 diabetes mellitus already benefit from a new generation of continuous glucose monitoring (CGM) systems. Apart from the increased accuracy these new devices can be used for up to 180 days and do not require daily calibration. This article provides a short overview of the innovations in CGM systems and the current status in the development of the artificial pancreas.


Assuntos
Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/terapia , Hipoglicemia/terapia , Pâncreas Artificial , Glicemia , Alemanha , Humanos , Sistemas de Infusão de Insulina
6.
Rev Med Suisse ; 15(654): 1202-1203, 2019 Jun 05.
Artigo em Francês | MEDLINE | ID: mdl-31166677
7.
Drugs ; 79(10): 1089-1101, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31190305

RESUMO

Type 1 diabetes is characterised by insulin deficiency caused by autoimmune destruction of the pancreatic beta cells. The treatment of type 1 diabetes is exogenous insulin in the form of multiple daily injections or continuous subcutaneous insulin infusion. Advances in diabetes technology have been exponential in the past few decades, culminating in studies to develop an automated artificial pancreas, also known as the closed-loop system. This has recently led to a commercially available, hybrid artificial pancreas in the USA and Europe. This review article aims to provide an overview of the rationale for an artificial pancreas system and an update of the current state of artificial pancreas development. We explore the different types of artificial pancreas systems being studied, including the use of adjunctive therapy, and the use of these systems in different groups of users. In addition, we discuss the potential psychosocial impact and the challenges and limitations of implementing artificial pancreas use into clinical practice.


Assuntos
Diabetes Mellitus Tipo 1/cirurgia , Diabetes Mellitus Tipo 1/terapia , Sistemas de Infusão de Insulina , Pâncreas Artificial , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Técnicas Biossensoriais/métodos , Glicemia/metabolismo , Criança , Pré-Escolar , Liberação Controlada de Fármacos , Humanos , Hipoglicemiantes/farmacologia , Lactente , Insulina/farmacologia , Pessoa de Meia-Idade
8.
Diabetes Technol Ther ; 21(4): 159-169, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30888835

RESUMO

OBJECTIVE: Hybrid closed-loop (HCL) artificial pancreas (AP) systems are now moving from research settings to widespread clinical use. In this study, the inControl algorithm developed by TypeZero Technologies was embedded to a commercial Tandem t:slim X2 insulin pump, now called Control-IQ, paired with a Dexcom G6 continuous glucose monitor and tested for superiority against sensor augmented pump (SAP) therapy. Both groups were physician-monitored throughout the clinical trial. RESEARCH DESIGN AND METHODS: In a randomized controlled trial, 24 school-aged children (6-12 years) with type 1 diabetes (T1D) participated in a 3-day home-use trial at two sites: Stanford University and the Barbara Davis Center (50% girls, 9.6 ± 1.9 years of age, 4.5 ± 1.9 years of T1D, baseline hemoglobin A1c 7.35% ± 0.68%). Study subjects were randomized 1:1 at each site to either HCL AP therapy with the Control-IQ system or SAP therapy with remote monitoring. RESULTS: The primary outcome, time in target range 70-180 mg/dL, using Control-IQ significantly improved (71.0% ± 6.6% vs. 52.8% ± 13.5%; P = 0.001) and mean sensor glucose (153.6 ± 13.5 vs. 180.2 ± 23.1 mg/dL; P = 0.003) without increasing hypoglycemia time <70 mg/dL (1.7% [1.3%-2.1%] vs. 0.9% [0.3%-2.7%]; not significant). The HCL system was active for 94.4% of the study period. Subjects reported that use of the system was associated with less time thinking about diabetes, decreased worry about blood sugars, and decreased burden in managing diabetes. CONCLUSIONS: The use of the Tandem t:slim X2 with Control-IQ HCL AP system significantly improved time in range and mean glycemic control without increasing hypoglycemia in school-aged children with T1D during remote monitored home use.


Assuntos
Automonitorização da Glicemia , Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Pâncreas Artificial , Criança , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Masculino , Resultado do Tratamento
9.
Med Biol Eng Comput ; 57(7): 1437-1449, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30895514

RESUMO

This paper deals with the development of a control algorithm that can predict optimal insulin doses without patients' intervention in fully automated artificial pancreas system. An online-tuned model based compound controller comprising an online-tuned internal model control (IMC) algorithm and an enhanced IMC (eIMC) algorithm along with a meal detection module is proposed. Volterra models, used to develop IMC and eIMC algorithms, are developed online using recursive least squares (RLS) filter. The time domain kernels, computed online using RLS filter, are converted into frequency domain to obtain Volterra transfer function (VTF). VTFs are used to develop both IMC and eIMC algorithms. The compound controller is designed in such a way that eIMC predicts insulin doses when the glucose rate increase detector of meal detection module is positive, otherwise conventional IMC takes the control action. Experimental results show that the compound controller performs robustly in the presence of higher and irregular amounts of meal disturbances at random times, very high actuator and sensor noises and also with the variation in insulin sensitivity. The combination of compound control strategy and meal detection module compensates the shortcomings of both slow subcutaneous insulin action that causes postprandial hyperglycemia, and delayed peak of action that causes hypoglycaemia. Graphical Abstract A fully-automated artificial pancreas system containing glucose sensor, insulin pump and control algorithm. Block diagram showing the control algorithm i.e., online-tuned compound IMC comprising enhanced IMC, conventional IMC and meal detection module, developed in the present work.


Assuntos
Algoritmos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Insulina/administração & dosagem , Refeições , Pâncreas Artificial , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Simulação por Computador , Diabetes Mellitus Tipo 1/sangue , Humanos , Insulina/sangue
10.
Diabetes Technol Ther ; 21(4): 183-200, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30839227

RESUMO

OBJECTIVE: We produced, through a systematic review of quantitative and qualitative evidence, a synthesis of the issues of importance (values and preferences) to adult patients with type 1 diabetes regarding treatment with automated insulin delivery systems. METHODS: We searched MEDLINE, CINAHL, EMBASE, and PsycINFO from the inception of each database through September 2018. We included studies examining patient values and preferences for outcomes related to continuous subcutaneous insulin infusion or artificial pancreas treatment. We compiled structured summaries of the results and assessed the relative importance of each outcome. GRADE (Grading of Recommendations, Assessment Development, and Evaluation) and CERQual (Confidence in Evidence from Reviews of Qualitative research) approaches provided the structure for the evaluation of the quality of evidence and confidence in the findings. A mixed-methods result-based convergent design provided the structure for integration and presentation of results. RESULTS: We reviewed 1665 unique citations; 19 studies (8 quantitative and 11 qualitative) proved eligible. Glycemic control is the key attribute that drives patients' preference. Reduction of glycemic variability and decreased incidence of hypoglycemia and chronic complications proved of intermediate importance and were ranked similarly to components of treatment burden, including the size and appearance of devices, cost, ease of use, and the embarrassment of public use. CONCLUSIONS: Clinician guidance may play a crucial role in determining patient values and preferences (for instance, patients' priority in glucose control rather than avoiding diabetic complications). Our results provide guidance for clinicians in discussing preferred insulin delivery systems with patients with type 1 diabetes.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Pâncreas Artificial , Preferência do Paciente , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Humanos , Insulina/uso terapêutico
11.
Diabet Med ; 36(5): 644-652, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30761592

RESUMO

AIM: Participants in clinical trials assessing automated insulin delivery systems report perceived benefits and burdens that reflect their experiences and may predict their likelihood of uptake and continued use of this novel technology. Despite the importance of understanding their perspectives, there are no available validated and reliable measures assessing the psychosocial aspects of automated insulin delivery systems. The present study assesses the initial psychometric properties of the INSPIRE measures, which were developed for youth and adults with Type 1 diabetes, as well as parents and partners. METHODS: Data from 292 youth, 159 adults, 150 parents of youth and 149 partners of individuals recruited from the Type 1 Diabetes Exchange Registry were analysed. Participants completed INSPIRE questionnaires and measures of quality of life, fear of hypoglycaemia, diabetes distress, glucose monitoring satisfaction. Exploratory factor analysis assessed factor structures. Associations between INSPIRE scores and other measures, HbA1c , and technology use assessed concurrent and discriminant validity. RESULTS: Youth, adult, parent and partner measures assess positive expectancies of automated insulin delivery systems. Measures range from 17 to 22 items and are reliable (α = 0.95-0.97). Youth, adult and parent measures are unidimensional; the partner measure has a two-factor structure (perceptions of impact on partners versus the person with diabetes). Measures showed concurrent and discriminant validity. CONCLUSIONS: INSPIRE measures assessing the positive expectancies of automated insulin delivery systems for youth, adults, parents and partners have meaningful factor structures and are internally consistent. The developmentally sensitive INSPIRE measures offer added value as clinical trials test newer systems, systems become commercially available and clinicians initiate using these systems.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Medidas de Resultados Relatados pelo Paciente , Psicometria/métodos , Inquéritos e Questionários , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Glicemia/análise , Automonitorização da Glicemia/instrumentação , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Diabetes Mellitus Tipo 1/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pâncreas Artificial/normas , Satisfação do Paciente/estatística & dados numéricos , Psicometria/normas , Sistema de Registros/estatística & dados numéricos , Inquéritos e Questionários/normas , Adulto Jovem
12.
Diabetes Technol Ther ; 21(2): 73-80, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30649925

RESUMO

BACKGROUND: Use of artificial pancreas (AP) requires seamless interaction of device components, such as continuous glucose monitor (CGM), insulin pump, and control algorithm. Mobile AP configurations also include a smartphone as computational hub and gateway to cloud applications (e.g., remote monitoring and data review and analysis). This International Diabetes Closed-Loop study was designed to demonstrate and evaluate the operation of the inControl AP using different CGMs and pump modalities without changes to the user interface, user experience, and underlying controller. METHODS: Forty-three patients with type 1 diabetes (T1D) were enrolled at 10 clinical centers (7 United States, 3 Europe) and 41 were included in the analyses (39% female, >95% non-Hispanic white, median T1D duration 16 years, median HbA1c 7.4%). Two CGMs and two insulin pumps were tested by different study participants/sites using the same system hub (a smartphone) during 2 weeks of in-home use. RESULTS: The major difference between the system components was the stability of their wireless connections with the smartphone. The two sensors achieved similar rates of connectivity as measured by percentage time in closed loop (75% and 75%); however, the two pumps had markedly different closed-loop adherence (66% vs. 87%). When connected, all system configurations achieved similar glycemic outcomes on AP control (73% [mean] time in range: 70-180 mg/dL, and 1.7% [median] time <70 mg/dL). CONCLUSIONS: CGMs and insulin pumps can be interchangeable in the same Mobile AP system, as long as these devices achieve certain levels of reliability and wireless connection stability.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Pâncreas Artificial , Adolescente , Adulto , Idoso , Algoritmos , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Smartphone , Resultado do Tratamento , Adulto Jovem
13.
Diabetes Obes Metab ; 21(3): 601-610, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30350477

RESUMO

AIM: To characterize the pharmacokinetic and pharmacodynamic properties of dasiglucagon, a novel, stable and liquid formulated glucagon analogue, during hypoglycaemic and euglycaemic conditions in adult patients with type 1 diabetes mellitus. RESEARCH DESIGN AND METHODS: In this randomized double-blind trial, 17 patients received four single subcutaneous doses (0.03, 0.08, 0.2 and 0.6 mg) of dasiglucagon (4 mg/mL formulation) under euglycaemic (plasma glucose [PG] 5.6 mmol/L [100 mg/dL]) or hypoglycaemic (PG 3.1-3.7 mmol/L [56-66 mg/dL]) conditions. For comparison, three doses (0.03, 0.08 and 0.2 mg) of a commercial glucagon formulation (Eli Lilly) were investigated at euglycaemia. RESULTS: Dasiglucagon led to a dose-dependent and rapid increase in PG levels across all doses tested (mean increases 30 minutes post-dosing of 2.2 to 4.4 mmol/L [39-80 mg/dL] from euglycaemia and 1.3 to 5.2 mmol/L [24-94 mg/dL] from hypoglycaemia), which was higher than the rises elicited by similar doses of commercial glucagon (1.7-3.9 mmol/L [30-71 mg/dL]). The median time (range) to an increase in PG of >1.1 mmol/L (20 mg/dL) was <20 (18-19.5) minutes with 0.03 mg dasiglucagon and, with higher doses, the median times ranged from 9 to 15 minutes (commercial glucagon 13-14 minutes). In hypoglycaemia, 0.03 and 0.08 mg dasiglucagon re-established normoglycaemia (PG ≥3.9 mmol/L [70 mg/dL]) within median times of 14 and 10 minutes, respectively. Nausea and vomiting occurred more frequently with dasiglucagon than with commercial glucagon at identical doses which might be attributable to dasiglucagon's higher potency. CONCLUSION: Dasiglucagon rapidly increased PG at doses of 0.03 to 0.6 mg in a dose-dependent manner and, therefore, is a good candidate for use in dual-hormone artificial pancreas systems.


Assuntos
Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/metabolismo , Glucagon/administração & dosagem , Glucagon/farmacocinética , Hipoglicemia/tratamento farmacológico , Adolescente , Adulto , Área Sob a Curva , Glicemia/metabolismo , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Glucagon/efeitos adversos , Glucagon/análogos & derivados , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/metabolismo , Injeções Subcutâneas , Insulina/administração & dosagem , Insulina/efeitos adversos , Sistemas de Infusão de Insulina , Masculino , Pessoa de Meia-Idade , Pâncreas Artificial , Adulto Jovem
14.
Metabolism ; 90: 20-30, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30321535

RESUMO

OBJECTIVE: Artificial pancreas is a technology that minimizes user input by bridging continuous glucose monitoring and insulin pump treatment, and has proven safety in the adult population. The purpose of this systematic review and meta-analysis is to evaluate the efficacy of closed-loop (CL) systems in the glycemic control of non-adult type 1 diabetes patients in both a pairwise and network meta-analysis (NMA) context and investigate various parameters potentially affecting the outcome. METHODS: Literature was systematically searched using the MEDLINE (1966-2018), Scopus (2004-2018), Cochrane Central Register of Controlled Trials (CENTRAL) (1999-2018), Clinicaltrials.gov (2008-2018) and Google Scholar (2004-2018) databases. Studies comparing the glycemic control in CL (either single- or dual-hormone) with continuous subcutaneous insulin infusion (CSII) in people with diabetes (PWD) aged <18 years old were deemed eligible. The primary outcome analysis was conducted with regard to time spent in the target glycemic range. All outcomes were evaluated in NMA in order to investigate potential between-algorithm differences. Pairwise meta-analysis and meta-regression were performed using the RevMan 5.3 and Open Meta-Analyst software. For NMA, the package pcnetmetain R 3.5.1 was used. RESULTS: The meta-analysis was based on 25 studies with a total of 504 PWD. The CL group was associated with significantly higher percentage of time spent in the target glycemic range (Mean (SD): 67.59% (SD: 8.07%) in the target range and OL PWD spending 55.77% (SD: 11.73%), MD: -11.97%, 95% CI [-18.40, -5.54%]) and with lower percentages of time in hyperglycemia (MD: 3.01%, 95% CI [1.68, 4.34%]) and hypoglycemia (MD: 0.67%, 95% CI [0.21, 1.13%]. Mean glucose was also decreased in the CL group (MD: 0.75 mmol/L, 95% CI [0.18-1.33]). The NMA arm of the study showed that the bihormonal modality was superior to other algorithms and standard treatment in lowering mean glucose and increasing time spent in the target range. The DiAs platform was superior to PID in controlling hypoglycemia and mean glucose. Time in target range and mean glucose were unaffected by the confounding factors tested. CONCLUSIONS: The findings of this meta-analysis suggest that artificial pancreas systems are superior to the standard sensor-augmented pump treatment of type 1 diabetes mellitus in non-adult PWD. Between-algorithm differences are also addressed, implying a superiority of the bihormonal treatment modality. Future large-scale studies are needed in the field to verify these outcomes and to determine the optimal algorithm to be used in the clinical setting.


Assuntos
Diabetes Mellitus Tipo 1/terapia , Pâncreas Artificial , Adolescente , Glicemia/análise , Glicemia/metabolismo , Automonitorização da Glicemia , Criança , Pré-Escolar , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Humanos , Lactente , Recém-Nascido , Insulina/administração & dosagem , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Metanálise em Rede , Pâncreas Artificial/efeitos adversos , Resultado do Tratamento
15.
Diabetes Technol Ther ; 21(1): 35-43, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30547670

RESUMO

BACKGROUND: There is an unmet need for a modular artificial pancreas (AP) system for clinical trials within the existing regulatory framework to further AP research projects from both academia and industry. We designed, developed, and tested the interoperable artificial pancreas system (iAPS) smartphone app that can interface wirelessly with leading continuous glucose monitors (CGM), insulin pump devices, and decision-making algorithms while running on an unlocked smartphone. METHODS: After algorithm verification, hazard and mitigation analysis, and complete system verification of iAPS, six adults with type 1 diabetes completed 1 week of sensor-augmented pump (SAP) use followed by 48 h of AP use with the iAPS, a Dexcom G5 CGM, and either a Tandem or Insulet insulin pump in an investigational device exemption study. The AP system was challenged by participants performing extensive walking without exercise announcement to the controller, multiple large meals eaten out at restaurants, two overnight periods, and multiple intentional connectivity interruptions. RESULTS: Even with these intentional challenges, comparison of the SAP phase with the AP study showed a trend toward improved time in target glucose range 70-180 mg/dL (78.8% vs. 83.1%; P = 0.31), and a statistically significant reduction in time below 70 mg/dL (6.1% vs. 2.2%; P = 0.03). The iAPS system performed reliably and showed robust connectivity with the peripheral devices (99.8% time connected to CGM and 94.3% time in closed loop) while requiring limited user intervention. CONCLUSIONS: The iAPS system was safe and effective in regulating glucose levels under challenging conditions and is suitable for use in unconstrained environments.


Assuntos
Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/terapia , Sistemas de Infusão de Insulina , Aplicativos Móveis , Pâncreas Artificial , Adulto , Algoritmos , Glicemia/efeitos dos fármacos , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Masculino , Pesquisa , Smartphone , Resultado do Tratamento
16.
IEEE Trans Biomed Eng ; 66(4): 1045-1054, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30142748

RESUMO

OBJECTIVE: Zone model predictive control (MPC) has been proven to be an efficient approach to closed-loop insulin delivery in clinical studies. In this paper, we aim to safely reduce mean glucose levels by proposing control penalty adaptation in the cost function of zone MPC. METHODS: A zone MPC method with a dynamic cost function that updates its control penalty parameters in real time according to the predicted glucose and its rate of change is developed. The proposed method is evaluated on the entire 100-adult cohort of the FDA-accepted UVA/Padova T1DM simulator and compared with the zone MPC tested in an extended outpatient study. RESULTS: For unannounced meals, the proposed method leads to statistically significant improvements in terms of mean glucose (153.8 mg/dL vs. 159.0 mg/dL; ) and percentage time in [70, 180] mg/dL ([Formula: see text] vs. [Formula: see text]; ) without increasing the risk of hypoglycemia. Performance for announced meals is similar to that obtained without adaptation. The proposed method also behaves properly and safely for scenarios of moderate meal-bolus and basal rate mismatches, as well as simulated unannounced exercise. Advisory-mode analysis based on clinical data indicates that the method can reduce glucose levels through suggesting additional safe amounts of insulin on top of those suggested by the zone MPC used in the study. CONCLUSION: The proposed method leads to improved glucose control without increasing hypoglycemia risks. SIGNIFICANCE: The results validate the feasibility of improving glucose regulation through glucose- and velocity-dependent control penalty adaptation in MPC design.


Assuntos
Glicemia , Sistemas de Infusão de Insulina , Modelos Estatísticos , Pâncreas Artificial , Adulto , Algoritmos , Glicemia/análise , Glicemia/efeitos dos fármacos , Simulação por Computador , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Humanos , Insulina/administração & dosagem , Insulina/uso terapêutico , Refeições
17.
Artif Organs ; 43(4): 386-398, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30159902

RESUMO

Artificial pancreas (AP) is an important treatment for patients with Type 1 diabetes (T1D). The control algorithm adopted in an AP system determines its reliability and accuracy. The generalized predictive control (GPC) is a representative adaptive control algorithm and has been widely applied to AP systems. However, we found that the traditional GPC controller does not work well for adolescents with T1D because of their high-fluctuating blood glucose and high insulin resistance. Here, we propose an improved GPC algorithm with an adaptive reference glucose trajectory and an adaptive softening factor. The slopes of the reference trajectory and the value of softening factor are calculated real-time on the basis of the blood glucose concentration (BGC) variations. In silico testing was done using the US Food and Drug Administration (FDA) approved virtual patient software T1D mellitus. The BGC trace and density of 20 patient-subjects (10 adults and 10 adolescents) were recorded. Results showed that the average BGC percentage within the target regions (70-180 mg/dL) of the tests with adaptive reference glucose trajectory and softening factor for adolescents (0.93 ± 0.07) was significantly higher than that of the traditional GPC algorithm tests (0.88 ± 0.11), suggesting that the control quality of the blood glucose of adolescents is significantly improved with our GPC algorithm. Therefore, our improved GPC controller is effective and should have a good applicability in AP systems.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/terapia , Pâncreas Artificial , Adolescente , Adulto , Algoritmos , Simulação por Computador , Humanos , Modelos Biológicos , Software
18.
Anesth Analg ; 128(5): 902-906, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30198923

RESUMO

Type 1 diabetes mellitus is a lifelong condition. It requires intensive patient involvement including frequent glucose measurements and subcutaneous insulin dosing to provide optimal glycemic control to decrease short- and long-term complications of diabetes mellitus without causing hypoglycemia. Variations in insulin pharmacokinetics and responsiveness over time in addition to illness, stress, and a myriad of other factors make ideal glucose control a challenge. Control-to-range and control-to-target artificial pancreas devices (closed-loop artificial pancreas devices [C-APDs]) consist of a continuous glucose monitor, response algorithm, and insulin delivery device that work together to automate much of the glycemic management for an individual while continually adjusting insulin dosing toward a glycemic target. In this way, a C-APD can improve glycemic control and decrease the rate of hypoglycemia. The MiniMed 670G (Medtronic, Fridley, MN) system is currently the only Food and Drug Administration-cleared C-APD in the United States. In this system, insulin delivery is continually adjusted to a glucose concentration, and the patient inputs meal-time information to modify insulin delivery as needed. Data thus far suggest improved glycemic control and decreased hypoglycemic events using the system, with decreased need for patient self-management. Thus, the anticipated use of these devices is likely to increase dramatically over time. There are limited case reports of safe intraoperative use of C-APDs, but the Food and Drug Administration has not cleared any device for such use. Nonetheless, C-APDs may offer an opportunity to improve patient safety and outcomes through enhanced intraoperative glycemic control. Anesthesiologists should become familiar with C-APD technology to help develop safe and effective protocols for their intraoperative use. We provide an overview of C-APDs and propose an introductory strategy for intraoperative study of these devices.


Assuntos
Diabetes Mellitus Tipo 1/terapia , Hipoglicemia/terapia , Sistemas de Infusão de Insulina , Pâncreas Artificial , Período Perioperatório , Algoritmos , Anestesia com Circuito Fechado/métodos , Anestesiologia/métodos , Anestesiologia/normas , Glicemia , Automonitorização da Glicemia/métodos , Diabetes Mellitus Tipo 1/sangue , Desenho de Equipamento , Humanos , Hiperglicemia , Hipoglicemiantes/administração & dosagem , Pacientes Internados , Insulina/administração & dosagem , Monitorização Ambulatorial/métodos , Pacientes Ambulatoriais , Resultado do Tratamento
19.
Diabet Med ; 36(3): 279-286, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30183096

RESUMO

The artificial pancreas is now a viable treatment option for people with Type 1 diabetes and has demonstrated improved glycaemic outcomes while also reducing the onus of self-management of Type 1 diabetes. Closed-loop glucose-responsive insulin delivery guided by real-time sensor glucose readings can accommodate highly variable day-to-day insulin requirements and reduce the hypoglycaemia risk observed with tight glycaemic control in Type 1 diabetes. In 2011, the James Lind Alliance research priorities for Type 1 diabetes were produced and priority 3 was to establish whether an artificial pancreas (closed-loop system) for Type 1 diabetes is effective. This review focuses on the progress that has been made in the evolution of closed-loop systems as an effective treatment option for Type 1 diabetes. Development of closed-loop systems has advanced from feasibility evaluations in highly supervised settings over short periods, to clinical studies in free-living, unsupervised conditions lasting several months. The approval in the USA of the first hybrid closed-loop system (MiniMed® 670G pump, Medtronic, Northridge, CA, USA) in 2016 for use in Type 1 diabetes reflects these advancements. We discuss the evidence from clinical studies that closed-loop systems are effective with improved glycaemic outcomes, reduced hypoglycaemia and had positive end-user acceptance in children, adolescents, adults and pregnant women with Type 1 diabetes. We also present the outlook for future closed-loop systems in the treatment of Type 1 diabetes and identify the challenges facing the wide-spread clinical adoption of this technology.


Assuntos
Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Pâncreas Artificial , Adolescente , Adulto , Glicemia/análise , Glicemia/efeitos dos fármacos , Automonitorização da Glicemia/efeitos adversos , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Criança , Feminino , Humanos , Sistemas de Infusão de Insulina/efeitos adversos , Sistemas de Infusão de Insulina/normas , Pâncreas Artificial/efeitos adversos , Pâncreas Artificial/normas , Gravidez , Gravidez em Diabéticas/sangue , Gravidez em Diabéticas/tratamento farmacológico , Resultado do Tratamento
20.
J Artif Organs ; 22(2): 154-159, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30456660

RESUMO

Although tight glucose control might reduce inflammation after cardiac surgery, it remains unclear whether inflammation can be controlled by maintaining glucose levels within 110-180 mg/dL. We hypothesized that a glucose target range of 110-180 mg/dL decreases inflammation after cardiovascular surgery. This retrospective study included 72 cardiovascular surgery patients divided into two groups according to the glucose control approach. Patients allocated to the closed-loop group received closed-loop glucose control (target glucose levels at 110-180 mg/dL) from admission to the intensive care unit until 9 a.m. on postoperative day (POD) 1. Patients allocated to the conventional group received conventional glucose control using a sliding scale method to maintain blood glucose levels < 200 mg/dL. Primary outcomes were C-reactive protein (CRP) levels on PODs 1, 2, and 7. Data were reported as mean ± standard deviation. Comparisons were performed using the chi-squared test and unpaired t test, with p < 0.05 indicating statistical significance. The closed-loop group had significantly lower average glucose levels (169 ± 24 vs. 201 ± 36 mg/dL, p < 0.001) and standard deviation of glucose levels (22 ± 13 vs. 44 ± 20 mg/dL; p < 0.001). The CRP levels on PODs 2 and 7 were significantly lower in the closed-loop group than in the conventional group (10.8 ± 5.6 vs. 14.1 ± 5.7 mg/dL, p = 0.02; 4.6 ± 2.5 vs. 7.3 ± 4.0 mg/dL, p < 0.001; respectively). Our findings suggest that glucose control using a closed-loop device might decrease inflammation after cardiovascular surgery without increasing hypoglycemia risk.


Assuntos
Glicemia , Procedimentos Cirúrgicos Cardiovasculares/efeitos adversos , Inflamação/prevenção & controle , Sistemas de Infusão de Insulina , Complicações Pós-Operatórias/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Hipoglicemia , Hipoglicemiantes , Inflamação/sangue , Inflamação/etiologia , Insulina/administração & dosagem , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Pâncreas Artificial , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos
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