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1.
N Engl J Med ; 383(9): 836-845, 2020 08 27.
Artigo em Inglês | MEDLINE | ID: mdl-32846062

RESUMO

BACKGROUND: A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes. METHODS: In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring. RESULTS: A total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group. CONCLUSIONS: In this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.).


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Bombas de Infusão Implantáveis , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Adolescente , Glicemia/análise , Criança , Diabetes Mellitus Tipo 1/sangue , Cetoacidose Diabética/etiologia , Feminino , Hemoglobina A Glicada/análise , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Injeções Subcutâneas , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Masculino , Pâncreas Artificial
2.
Rev Med Suisse ; 16(697): 1191-1196, 2020 Jun 10.
Artigo em Francês | MEDLINE | ID: mdl-32520457

RESUMO

Pump therapy has existed for over 40 years and provides a more flexible delivery of insulin. To date, almost 25% of type 1 diabetic patients have chosen this therapeutic option. In recent years, it has also been offered to patients with type 2 insulin-requiring diabetes. The choice of insulin pump is based on its indication, the patient's preference, lifestyle and knowledge of the disease. A risk of developing ketoacidosis in case of interruption of insulin delivery exists. Its implementation therefore requires a specialized interdisciplinary care team available in case of emergency.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Insulina/uso terapêutico , Pacientes Ambulatoriais , Cetoacidose Diabética/etiologia , Cetoacidose Diabética/prevenção & controle , Cetoacidose Diabética/terapia , Humanos , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos
3.
Expert Rev Med Devices ; 17(7): 707-720, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32569476

RESUMO

INTRODUCTION: Type 1 diabetes is a lifelong disease with high management burden. The majority of people with type 1 diabetes fail to achieve glycemic targets. Algorithm-driven automated insulin delivery (closed-loop) systems aim to address these challenges. This review provides an overview of commercial and emerging closed-loop systems. AREAS COVERED: We review safety and efficacy of commercial and emerging hybrid closed-loop systems. A literature search was conducted and clinical trials using day-and-night closed-loop systems during free-living conditions were used to report on safety data. We comment on efficacy where robust randomized controlled trial data for a particular system are available. We highlight similarities and differences between commercial systems. EXPERT OPINION: Study data shows that hybrid closed-loop systems are safe and effective, consistently improving glycemic control when compared to standard therapy. While a fully closed-loop system with minimal burden remains the end-goal, these hybrid closed-loop systems have transformative potential in diabetes care.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Sistemas de Infusão de Insulina/efeitos adversos , Algoritmos , Glicemia/análise , Pessoal de Saúde/educação , Humanos , Resultado do Tratamento
4.
Diabetes Res Clin Pract ; 162: 108089, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32087268

RESUMO

AIMS: Aim of our observational study was to assess the prevalence of allergic contact dermatitis among children and adolescents with type 1 diabetes who use technological devices for diabetes treatment and its management. Secondary outcome was to identify possible clinical and/or demographic variables that could be associated to contact dermatitis. METHODS: Among a total of 215 patients using insulin pumps and/or glucose sensors followed-up at our Pediatric Diabetes Centre between January and September 2018, 64 patients were enrolled and 42 (19 male and 23 female) completed the study. Demographic and clinical features of the study population were statistically analysed. All the patients underwent patch testing with specific allergens belonged to resin and acrylate classes. RESULTS: Eighteen patients experienced skin reactions suggestive of allergic contact dermatitis, demonstrating a prevalence of 8.4%. None of the demographic or clinical variables were associated to skin reactions. Colophonium was the most identified sensitizing allergen (87.5% of the cases). CONCLUSIONS: The rate of sensitization to allergens included into diabetes devices among pediatric patients is higher than commonly assumed. Well-designed studies are needed to better investigate the association between type 1 diabetes and allergic contact dermatitis. Moreover, we suggest that manufactures should supply detailed information about adhesives in order to avoid dermatological complications and consequently a worsening of disease management and patients' quality of life.


Assuntos
Acrilatos/efeitos adversos , Alérgenos/efeitos adversos , Automonitorização da Glicemia/instrumentação , Dermatite Alérgica de Contato/etiologia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Sistemas de Infusão de Insulina/efeitos adversos , Qualidade de Vida , Adolescente , Adulto , Automonitorização da Glicemia/efeitos adversos , Criança , Pré-Escolar , Dermatite Alérgica de Contato/epidemiologia , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/complicações , Feminino , Humanos , Itália/epidemiologia , Masculino , Testes do Emplastro , Prevalência , Adulto Jovem
5.
Hautarzt ; 71(3): 205-210, 2020 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-31965206

RESUMO

The design and development of insulin pumps and various glucose sensor systems has an enormous impact on life quality of diabetic patients. Surveillance and therapy of diabetes has improved due to the new diabetic devices, which are affixed to the patients' skin for several days. Since their introduction, irritant and allergic contact dermatitis have been frequently reported. Patients often acquire contact sensitization to isobornyl acrylate, N,N-dimethylacrylamide or formerly to 2­ethyl-cyanoacrylate. These contact allergens were found in the patch, in the glue to affix the box on the patch or in the casing of the system itself. Development of contact allergy to substances of these systems may result in the need to abandon modern diabetic devices.


Assuntos
Adesivos/efeitos adversos , Alérgenos/efeitos adversos , Automonitorização da Glicemia/efeitos adversos , Dermatite Alérgica de Contato/etiologia , Inflamação/etiologia , Sistemas de Infusão de Insulina/efeitos adversos , Testes do Emplastro/métodos , Acetatos , Automonitorização da Glicemia/instrumentação , Compostos Bicíclicos com Pontes , Dermatite Alérgica de Contato/prevenção & controle , Diabetes Mellitus , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Reação a Corpo Estranho/etiologia , Glucose , Humanos , Insulinas/administração & dosagem , Insulinas/uso terapêutico
6.
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
7.
J Pediatr Endocrinol Metab ; 32(8): 843-849, 2019 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-31318694

RESUMO

Background To evaluate the safety of fasting during the holy month of Ramadan among children and adolescent with type 1 diabetes (T1D). Methods A retrospective cohort study of 50 children and adolescents with T1D whose mean age was 12.7 ± 2.1 years was conducted. Twenty-seven patients (54%) were on multiple daily injections (MDI) insulin regimen and 23 (46%) were on insulin pump therapy. Before fasting for Ramadan, children and their families were evaluated and educated about diabetes management during Ramadan. Hemoglobin A1c (HbA1c), weight, number of days fasted, hypoglycemia and hyperglycemia episodes, and emergency hospital visits were collected and analyzed after completing the month. Participants were compared according to the insulin treatment regimen and their glycemic control level before Ramadan. Results The children were able to fast 20 ± 9.9 days of Ramadan, and the most common cause for breaking the fast was mild hypoglycemia (7.8% among all cases). There was no significant difference between the two insulin regimen groups in breaking fast days, frequency of hypo- or hyperglycemia, weight and HbA1c changes post Ramadan. Patients with HbA1c ≤ 8.5% were able to fast more days during Ramadan with significantly less-frequent hypoglycemic attacks as compared to patients with HbA1c > 8.5 (1.2 ± 1.5 vs. 3.3 ± 2.9 days of hypoglycemia, p = 0.01, respectively). Conclusions Fasting for children with T1D above the age of 10 years is feasible and safe in both pump and non-pump users, and well-controlled patients are less likely to develop complications. Education of the families and their children before Ramadan, along with intensive monitoring of fasting children during the month are crucial.


Assuntos
Peso Corporal , Diabetes Mellitus Tipo 1/tratamento farmacológico , Jejum/efeitos adversos , Hiperglicemia/prevenção & controle , Hipoglicemia/prevenção & controle , Sistemas de Infusão de Insulina/efeitos adversos , Insulina/administração & dosagem , Adolescente , Biomarcadores/análise , Glicemia/análise , Criança , Diabetes Mellitus Tipo 1/sangue , Feminino , Seguimentos , Hemoglobina A Glicada/análise , Humanos , Hiperglicemia/induzido quimicamente , Hiperglicemia/epidemiologia , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/efeitos adversos , Incidência , Insulina/efeitos adversos , Islamismo , Kuweit/epidemiologia , Masculino , Prognóstico , Estudos Retrospectivos
8.
Pediatr Diabetes ; 20(6): 759-768, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31099946

RESUMO

OBJECTIVE: Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control-IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control. METHODS: In a randomized controlled trial, 24 adolescents (ages 13-18 years) and 24 school-aged children (6-12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor-augmented pump (RM-SAP), and the experimental group used the t: slim X2 with Control-IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff. RESULTS: The Control-IQ system improved percent time within range (70-180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events. CONCLUSIONS: The use of the Control-IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM-SAP in pediatric patients with T1D during prolonged intensive winter sport activities.


Assuntos
Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Pâncreas Artificial , Esqui/fisiologia , Esportes/fisiologia , Adolescente , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Automonitorização da Glicemia/efeitos adversos , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Criança , Temperatura Baixa , Estudos Cross-Over , Desenho de Equipamento , Feminino , Humanos , Hiperglicemia/etiologia , Hipoglicemia/etiologia , Insulina/administração & dosagem , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Masculino , Pâncreas Artificial/efeitos adversos , Estações do Ano
9.
Acta Diabetol ; 56(9): 973-980, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30945047

RESUMO

Meta-analyses of clinical trials comparing CSII with traditional insulin injections usually show a small, but significant advantage of CSII with respect to HbA1c and risk of severe hypoglycemia. On the other hand, CSII is associated with a small, but relevant risk of ketoacidosis, mainly due to malfunction of insulin pump and/or catheter occlusion. During last time, the technology of insulin pumps and infusion sets has improved as the profound evolution in type and schemes with traditional insulin injections. Aim of the present study is to update previous meta-analyses comparing CSII with traditional insulin injections in subjects with type 1 diabetes. Specific subgroup analyses were designed for assessing the effects of CSII in comparison with basal-bolus MDI, with short-acting analogues as bolus and long-acting analogues as basal insulin. In addition, an exploratory analysis was performed to verify the effect of CSII in insulin-naïve patients with type 1 diabetes. The present analysis includes all randomized clinical trials comparing CSII with traditional injections in type 1 diabetes, with a duration of at least 12 weeks. Animal studies were excluded, whereas no language or date restriction was imposed. If duplicate publications of a single trial were present, the paper containing more adequate information was considered as principal publication. In trials comparing CSII with basal-bolus MDI, performed before the introduction of rapid-acting analogues, regular human insulin was used for CSII, and as prandial insulin in control groups. CSII was associated with a significant reduction of A1c, in comparison with MDI, irrespective of the use of either human insulin or rapid-acting analogues. However, in trials with rapid-acting analogue the advantage of CSII was significantly smaller than in trials with regular human insulin (HbA1c difference: - 0.29[- 0.46; - 0.13] vs - 1.93[- 1.84; - 0.42]%; p = 0.02). Different rapid-acting analogues provided similar results (HbA1c reduction vs MDI: - 0.25 [- 0.48; - 0.02]%, p = 0.03, and - 0.29 [- 0.49; - 0.09]%, p = 0.005, for lispro and aspart, respectively). In addition, in trials comparing CSII with basal-bolus MDI, CSII reduced HbA1c to a similar extent irrespective of the use of either NPH or long-acting analogues as basal insulin in the control groups (HbA1c reduction vs MDI: - 0.31 [- 0.55; - 0.06]%, p = 0.01, and - 0.20 [- 0.38; - 0.03]%, p = 0.02, for NPH and long-acting analogues, respectively. With respect to severe hypoglycemia, CSII did not produce a significant reduction of risk in comparison with traditional insulin injections. Conversely, CSII was associated with a significant increase in the incidence of reported diabetic ketoacidosis (DKA). Notably, the increased risk of DKA was significant in trials comparing CSII with conventional insulin therapy, whereas only a nonsignificant trend toward an increased risk was observed in comparisons with basal-bolus MDI. Only two trials comparing CSII with basal-bolus MDI, both using rapid-acting analogues, were performed on insulin-naïve type 1 diabetic patients. When those two trials were analyzed separately, CSII did not produce any relevant effect on HbA1c (difference from control: - 0.10[- 0.38; + 0.17]%; p = 0.46). No meta-analysis could be performed on either severe hypoglycemia or DKA, which were not reported by one of the two trials. CSII seems to produce a small improvement in HbA1c in patients with type 1 diabetes inadequately controlled with MDI. This apparent effect, which could be partly due to publication bias, is smaller when MDI is properly performed using basal-bolus schemes with short-acting insulin analogues. Other outcomes different from HbA1c (such as quality of life) could be relevant for the choice of CSII instead of MDI. In addition, further studies are needed to better define the profile of patients who could benefit most from CSII.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Cetoacidose Diabética/tratamento farmacológico , Cetoacidose Diabética/epidemiologia , Esquema de Medicação , Combinação de Medicamentos , Feminino , Hemoglobina A Glicada/análise , Hemoglobina A Glicada/metabolismo , Humanos , Hipoglicemia/induzido quimicamente , Hipoglicemia/epidemiologia , Hipoglicemiantes/efeitos adversos , Injeções Subcutâneas , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Sistemas de Infusão de Insulina/estatística & dados numéricos , Insulina de Ação Prolongada/administração & dosagem , Insulina de Ação Prolongada/efeitos adversos , Masculino , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos
10.
Diabetes Technol Ther ; 21(4): 215-221, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30943072

RESUMO

BACKGROUND: In a 4-month follow-up survey, we examined whether treatment with continuous subcutaneous insulin infusion (CSII) and/or continuous glucose monitoring (CGM) in adults with type 1 diabetes was associated with sustained skin problems and whether skin problems were associated with diabetes-related emotional distress. RESEARCH DESIGN AND METHODS: A total of 111 adult patients completed a follow-up questionnaire concerning skin problems as a result of CSII and/or CGM use. The questionnaire included a patient-reported outcome measure, the Problem Areas in Diabetes (PAID) scale. RESULTS: Current visible skin problems caused by CSII or CGM use were reported by 51 (46.0%) participants, in 34 (66.7%) of whom skin problems had been reported more than 4 months earlier. Seventy-two (64.9%) participants reported skin problems as a result of CSII use, whereas 38 (74.5%) reported skin problems owing to CGM use at some time. Itching was the most prevalent complaint. CSII-related itching was associated with a mean PAID score >20 (P = 0.01), and patients with more than one skin problem had an increased PAID score compared with those with one or no skin problems (P = 0.006). CONCLUSIONS: More than half patients treated with CSII, CGM, or both had experienced skin problems during 4 months of follow-up that were associated with increased diabetes burden. Skin problems represent a persistent health issue affecting diabetes-specific emotional distress.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Eczema/etiologia , Hipoglicemiantes/uso terapêutico , Sistemas de Infusão de Insulina/efeitos adversos , Insulina/uso terapêutico , Prurido/etiologia , Adulto , Idoso , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Adulto Jovem
11.
Diabetes Technol Ther ; 21(5): 231-237, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30925083

RESUMO

Background: A prior study (PRECISE II) demonstrated that an implantable continuous glucose monitoring (CGM) system (Eversense® CGM System) provided accurate glucose readings through the 90-day sensor life with a favorable safety profile in participants with type 1 or type 2 diabetes (T1D, T2D). This study was performed to further characterize the accuracy of the system. Methods: PRECISION was a prospective multicenter study that evaluated the accuracy and safety of Eversense among adults with T1D or T2D through 90 days (NCT02647905). Accuracy measures included percentage system agreement and mean absolute relative difference (MARD) between Eversense and Yellow Springs Instrument reference measurements from 40 to 400 mg/dL. The primary safety endpoint was incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days. An updated glucose calculation algorithm was also applied to the sensor data from the PRECISE II study to evaluate consistency of accuracy results. Results: Thirty-five participants received the CGM system. Eighty-five percent of CGM values were within 15/15% of reference and the MARD value against reference was 9.6% (95% confidence interval [CI]: 8.9-10.4). All sensors were functional through day 90. No device- or procedure-related SAEs occurred. Application of the updated algorithm to PRECISE II sensor data resulted in 87% of readings within 15/15% of reference and an MARD value against reference of 8.5% (95% CI: 8.0%-9.1%). Conclusions: PRECISION corroborated prior accuracy and safety findings of the Eversense CGM System through the 90-day sensor life. The updated algorithm improved accuracy of measurements in PRECISE II.


Assuntos
Automonitorização da Glicemia/instrumentação , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Sistemas de Infusão de Insulina/efeitos adversos , Adulto , Idoso , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Reprodutibilidade dos Testes
12.
J Forensic Leg Med ; 63: 34-39, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30856551

RESUMO

PURPOSE: To report a case in which autopsy findings and data from an insulin pump illustrate the course up to the death of a 31-year-old man with a history of type 1 diabetes mellitus who was found dead in his apartment with his insulin pump disassembled and placed in another room. METHODS: Autopsy findings including histological, toxicological and biochemical examination are presented. Postmortem download of data from the insulin pump gave the history of the pump, which included blood glucose, insulin bolus, carbohydrate intake and the time course in the days to death, and the pump settings were recorded. For this case report, police reports on the death as well as hospital records were also reviewed. RESULTS: At the patch for the insulin pump, nothing abnormal was found. Biochemical analysis showed glucose of 35 mmoL/L in vitreous humor fluid indicating antemortem hyperglycemia, and ketone bodies in the blood of 11.0 mmoL/L indicating ketoacidosis. Acute pulmonary hemostasis, chronic fat accumulation in the liver and acute fat accumulation in the kidneys were histological detected. There were no signs of late diabetic complications such as nephropathy or cardiovascular disease in the tissues. Insulin pump data showed that after three alarms, a power failure of the pump occurred leading to discontinuing insulin delivery, and about 48 h before the deceased was found dead, his body was depleted of insulin. CONCLUSION: The cause of death is believed to be diabetic ketoacidosis due to completely lack of insulin because of power failure of the insulin pump, which therefore has been a decisive factor in the cascade of events that led to death. The case is, to our knowledge, the first to illustrate a death caused by diabetic ketoacidosis which is supported by autopsy findings and by data of an insulin pump up to the time of power failure. It is a strong example of usefulness of postmortem download of data from insulin pumps to help determine the cause of death among diabetics. Forensic pathologists should therefore review data and history of the pump systematically.


Assuntos
Morte Súbita/etiologia , Cetoacidose Diabética/etiologia , Falha de Equipamento , Bombas de Infusão Implantáveis/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Adulto , Diabetes Mellitus Tipo 1/tratamento farmacológico , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Masculino
13.
Acta Med Port ; 32(1): 17-24, 2019 Feb 01.
Artigo em Português | MEDLINE | ID: mdl-30753799

RESUMO

INTRODUCTION: The use of continuous subcutaneous insulin infusion therapy in type 1 diabetes mellitus has increased due to its benefits on glycemic control and on the lifestyle flexibility. The aim of this study was to assess the impact of continuous subcutaneous insulin infusion therapy on glycemic control, body mass index, total daily dose of insulin and complications associated with this therapy, during 20 years of experience in Centro Hospitalar e Universitário de Coimbra. MATERIAL AND METHODS: This retrospective study included patients with type 1 diabetes mellitus who started continuous subcutaneous insulin infusion therapy up until 2005, followed at Centro Hospitalar e Universitário de Coimbra. Glycated hemoglobin A1c, body mass index, total daily dose of insulin and acute complications associated with continuous subcutaneous insulin infusion therapy were evaluated immediately prior to initiation of continuous subcutaneous insulin infusion therapy with follow-up at six months, one year, five, 10, 15 and 20 years. The frequency of acute complications associated with this type of therapy was also evaluated. RESULTS: This study included 20 patients (seven males, 13 females) with mean disease duration up to the start of continuous subcutaneous insulin infusion therapy of 16.1 ± 7.9 years, mean age of onset of continuous subcutaneous insulin infusion therapy of 31.1 ± 8.4 years and follow-up during 13.2 ± 2.3 years. The reasons for initiating pump therapy were: inadequate metabolic control in 15 patients, history of asymptomatic or severe hypoglycemia in four patients, and pregnancy/pregnancy planning in one patient. The previous median of glycated hemoglobin A1c was 9.3% (6.5 - 16.0) and, at six months, decreased to the minimum value of 7.2% (5.3 - 9.8); p < 0.0125. The reduction of glycated hemoglobin A1c remained statistically significant in the first 10 years of follow-up. There was a statistically significant difference in the body mass index variation at 10 years with continuous subcutaneous insulin infusion therapy compared to previous body mass index; 24.7 kg/m2 (18.9 - 31.8) vs 25,5 kg/m2 (18.9 - 38.9), p <0.0125. Daily insulin requirements were reduced from 56.5 U (32.0 - 94.0) to 43.8 U (33.0 - 64.0) (p < 0.0125) at six months and no statistical differences were found in the remaining follow-up. There were two severe episodes of hypoglycemia (incidence 0.0095/patient/year), five episodes of diabetic ketoacidosis (0.0238/patient/year) and no infections at the site of catheter insertion. DISCUSSION: This study shows that continuous subcutaneous insulin infusion therapy improved glycemic control, especially during the first 10 years of follow-up and allowed a significant decrease in total daily dose of insulin in the first six months. The rate of acute complications was low. CONCLUSION: Treatment with continuous subcutaneous insulin infusion therapy seems effective in achieving metabolic control in selected patients with type 1 diabetes mellitus.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Adulto , Índice de Massa Corporal , Diabetes Mellitus Tipo 1/sangue , Feminino , Seguimentos , Hemoglobina A Glicada/análise , Hemoglobina A Glicada/metabolismo , Humanos , Infusões Subcutâneas/efeitos adversos , Infusões Subcutâneas/métodos , Sistemas de Infusão de Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Portugal , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
14.
J Forensic Sci ; 64(1): 275-280, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29940703

RESUMO

Diabetes mellitus type 1 and type 2 are diseases characterized by impaired regulation of blood glucose due to decreased insulin production and insulin resistance, respectively. Management of diabetes mellitus often requires injection of exogenous insulin. Continuous subcutaneous insulin infusion (CSII or insulin pump) is a diabetes treatment modality utilizing a device to aid in regulation of glycemic control. Malfunctions in device components can have rare fatal consequences. Described in this report are six fatalities due to one such malfunction, the failure of plastic cannulas of CSII devices to penetrate the skin and deliver insulin, resulting in fatal diabetic ketoacidosis (DKA). The cases derive from four different death investigation systems. For each case, scene and autopsy findings are presented, as well as selected toxicology and histology findings. These cases illustrate the importance of careful examination of CSII devices in death investigations and introduce a discussion on discrepant manner of death classifications.


Assuntos
Diabetes Mellitus/tratamento farmacológico , Cetoacidose Diabética/etiologia , Sistemas de Infusão de Insulina/efeitos adversos , Adulto , Idoso , Glicemia/análise , Falha de Equipamento , Evolução Fatal , Feminino , Glicosúria/etiologia , Humanos , Infusões Subcutâneas , Masculino , Pessoa de Meia-Idade
15.
Am J Clin Dermatol ; 20(1): 97-114, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30361953

RESUMO

Diabetes mellitus is one of the most prevalent chronic diseases in the USA. If uncontrolled, diabetes can lead to devastating complications. Diabetes medications and medical devices largely contribute to the significant financial expense that the disease inflicts on affected individuals and society. Alongside significant economic burden, there are numerous cutaneous adverse effects associated with diabetes medications and medical devices. Despite the large and increasing number of individuals living with diabetes and the wide use of the related medications and medical devices, there is limited literature that comprehensively documents their cutaneous adverse effects. These cutaneous adverse effects are significant as they can worsen glycemic control, increase disease distress, and may increase risk of associated complications. Thus, it is important that providers can recognize these cutaneous adverse effects, identify the culprit agents, and can properly manage them. In this article, we provide a critical review of the cutaneous adverse effects of medications and devices used in the management of diabetes and provide insight into risk factors and prevention and an overview of therapeutic management. An emphasis is placed on clinical recognition and treatment for use of the medical providers who, regardless of practice setting, will treat patients with diabetes.


Assuntos
Automonitorização da Glicemia/efeitos adversos , Diabetes Mellitus/tratamento farmacológico , Erupção por Droga/etiologia , Hipoglicemiantes/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Glicemia/análise , Automonitorização da Glicemia/instrumentação , Diabetes Mellitus/sangue , Humanos , Hipoglicemiantes/administração & dosagem , Fatores de Risco
16.
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
17.
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
18.
Contact Dermatitis ; 79(6): 331-335, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30264920

RESUMO

Allergic contact dermatitis caused by medical devices for diabetes patients has been increasingly described in the literature in the last few years. This article reviews the cases of allergic contact dermatitis caused by insulin pumps and glucose sensors reported since the 1970s, the culprit allergen(s), the results of patch tests and/or chromatographic analysis, and preventive measures.


Assuntos
Automonitorização da Glicemia/efeitos adversos , Dermatite Alérgica de Contato/etiologia , Inflamação/etiologia , Sistemas de Infusão de Insulina/efeitos adversos , Acrilatos/efeitos adversos , Diabetes Mellitus Tipo 2/terapia , Feminino , Reação a Corpo Estranho/etiologia , Humanos , Masculino
19.
Curr Diab Rep ; 18(10): 81, 2018 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-30120619

RESUMO

PURPOSE OF REVIEW: Summarize safety issues related to patients using insulin pump therapy and continuous glucose monitoring systems (CGMS) in the outpatient setting when they are hospitalized and to review steps that can be taken to mitigate risk associated with use or discontinuation of these devices. RECENT FINDINGS: Two recent consensus conferences were held on the topics of inpatient use of insulin pumps and CGMS devices. In addition to commonly known safety issues (e.g., device malfunction, infection), cybersecurity and the vulnerability of contemporary technology to hacking have emerged. CGMS capabilities offer the promise of advancing the goal for development of glucometry (centralized monitoring of real-time glucose data). Strategies to assuring safe use of insulin pumps and CGMS in the hospital include collaboration between the patient and staff, proper patient selection, and clear policies and procedures outlining safe use. Available data indicates few adverse events associated with these devices in the hospital. Current data suggests, with proper patient selection and a clear process in place for glycemic management, that adverse events are rare, and consensus favors allowing use of the technology in the hospital. The topic of insulin pump and CGMS in the hospital would greatly benefit from more institutions reporting on their experiences and prospective clinical trials.


Assuntos
Automonitorização da Glicemia/efeitos adversos , Hospitais , Sistemas de Infusão de Insulina/efeitos adversos , Glicemia/análise , Automonitorização da Glicemia/instrumentação , Segurança Computacional , Humanos , Pacientes Internados
20.
Pediatr Diabetes ; 19(8): 1459-1466, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30129154

RESUMO

BACKGROUND: Long-term glycemic outcomes in people with type 1 diabetes (T1D) on insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) with appropriate control data are limited. Randomized controlled studies of technology in diabetes care are generally limited in duration and likely to have a selection bias. Hence, evaluation of population-based data provides a robust alternative evaluation of the benefits of insulin pump therapy. AIM: To investigate the outcomes of insulin pump therapy, as compared to injection therapy, in children with T1D attending a state-wide diabetes service in Western Australia. METHODS: Patients using insulin pump therapy between January 1999 and July 2016 were matched to patients on injection therapy on the basis of age, date of diagnosis, and hemoglobin A1C (HbA1c) at the start of pump therapy. RESULTS: A total of 513 pump-injection matches were identified. The pump cohort had a significantly lower mean HbA1c for the first 6 years of follow-up. The difference in HbA1c between the cohorts was observed by 6 months (3 mmol/mol [0.3%], standard error of the mean (SEM) 0.05, N = 463 matched pairs, P < 0.001) and was sustained with the greatest difference in HbA1c at 6 years (4 mmol/mol [0.4%], SEM 0.21, N = 112 matched pairs, P = 0.04). Beyond 6 years of follow-up, the HbA1c was not significantly lower in the pump cohort (N < 70 matched pairs). CONCLUSIONS: Patients using insulin pump therapy had a better long-term glycemic control relative to the matched injection therapy cohort. Large population-based cohort studies using real-world data provide a valuable perspective on evaluation of new technologies in children with T1D.


Assuntos
Diabetes Mellitus Tipo 1/tratamento farmacológico , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Fatores Etários , Glicemia/análise , Glicemia/efeitos dos fármacos , Estudos de Casos e Controles , Criança , Pré-Escolar , Estudos de Coortes , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/epidemiologia , Feminino , Seguimentos , Hemoglobina A Glicada/análise , Hemoglobina A Glicada/efeitos dos fármacos , Humanos , Lactente , Injeções Subcutâneas , Insulina/efeitos adversos , Sistemas de Infusão de Insulina/efeitos adversos , Masculino , Estudos Retrospectivos , Resultado do Tratamento
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