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1.
J Diabetes ; 2020 Mar 03.
Artigo em Inglês | MEDLINE | ID: mdl-32125763

RESUMO

The significant risks associated with pregnancies complicated by type 1 diabetes (T1D) were first recognized in the medical literature in the mid-twentieth century. Stringent glycemic control with hemoglobin A1c (HbA1c) values ideally less than 6% has been shown to improve maternal and fetal outcomes. The management options for pregnant women with T1D in the modern era include a variety of technologies to support self-care. Although self-monitoring of blood glucose (SMBG) and multiple daily injections (MDI) are often the recommended management options during pregnancy, many people with T1D utilize a variety of different technologies, including continuous glucose monitoring (CGM), continuous subcutaneous insulin infusion (CSII), and CSII including automated delivery or suspension algorithms. These systems have yielded invaluable diagnostic and therapeutic capabilities and have the potential to benefit this understudied higher-risk group. A recent prospective, multicenter study evaluating pregnant patients with T1D revealed that CGM significantly improves maternal glycemic parameters, is associated with fewer adverse neonatal outcomes, and minimizes burden. Outcome data for CSII, which is approved for use in pregnancy and has been utilized for several decades, remain mixed. Current evidence, although limited, for commercially available and emerging technologies for the management of T1D in pregnancy holds promise for improving patient and fetal outcomes. HIGHLIGHTS: The management of T1D in pregnancy has been enhanced in large part due to development of more effective glucose monitoring and insulin delivery systems. CGM has been demonstrated to improve glycemic control and minimize excursions in pregnant mothers and leads to better neonatal outcomes. CSII has often led to better maternal glycemic control; however, outcome data for its use in pregnancy remain mixed. Further research evaluating newer and upcoming technologies in this understudied population is needed.

2.
J Diabetes Sci Technol ; : 1932296819894974, 2019 Dec 21.
Artigo em Inglês | MEDLINE | ID: mdl-31867988

RESUMO

BACKGROUND: Knowledge regarding the burden and predictors of hypoglycemia among older adults with type 1 diabetes (T1D) is limited. METHODS: We analyzed baseline data from the Wireless Innovations for Seniors with Diabetes Mellitus (WISDM) study, which enrolled participants at 22 sites in the United States. Eligibility included clinical diagnosis of T1D, age ≥60 years, no real-time continuous glucose monitoring (CGM) use in prior three months, and HbA1c <10.0%. Blinded CGM data from 203 participants with at least 240 hours were included in the analyses. RESULTS: Median age of the cohort was 68 years (52% female, 93% non-Hispanic white, and 53% used insulin pumps). Mean HbA1c was 7.5%. Median time spent in the glucose range <70 mg/dL was 5.0% (72 min/day) and <54 mg/dL was 1.6% (24 min/day). Among all factors analyzed, only reduced hypoglycemia awareness was associated with greater time spent <54 mg/dL (median time of 2.7% vs 1.3% [39 vs 19 minutes per day] for reduced awareness vs aware/uncertain, respectively, P = .03). Participants spent a mean 56% of total time in target glucose range of 70-180 mg/dL and 37% of time above 180 mg/dL. CONCLUSIONS: Over half of older T1D participants spent at least an hour a day with glucose levels <70 mg/dL. Those with reduced hypoglycemia awareness spent over twice as much time than those without in a serious hypoglycemia range (glucose levels <54 mg/dL). Interventions to reduce exposure to clinically significant hypoglycemia and increase time in range are urgently needed in this age group.

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.
Biores Open Access ; 7(1): 123-130, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30147996

RESUMO

Gestational diabetes mellitus (GDM) can cause short- and long-term complications to the mother and fetus. While the precise mechanisms in preserving glucose balance in a healthy pregnancy are unknown, various growth factors and hormones have been implicated or associated with GDM risk in humans or rodents, including prolactin, tumor necrosis factor alpha (TNFα), osteoprotegerin (OPG), hepatocyte growth factor (HGF), and receptor activator of nuclear factor-kappa B ligand (RANKL). We aimed to evaluate the relationship of these and other protein markers in women with GDM. In this cross-sectional study, blood samples were collected from pregnant women with GDM and with normal glucose tolerance (NGT) at the 24- to 32-week obstetrical visit, during the 1-h oral glucose challenge test or 3-h oral glucose tolerance test. Blood plasma was analyzed for RANKL, OPG, prolactin, tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), HGF, plasminogen activator inhibitor type 1 (PAI-1), and TNFα. Forty-six women with NGT and 47 women with GDM were included (mean ± standard deviation maternal age 31.6 ± 5.7, mean ± standard deviation gestational age 28.1 ± 2.2 weeks). Groups were similar in terms of age, body mass index, gestational age, and race/ethnicity. Serum levels of OPG, prolactin, TRAIL, HGF, PAI-1, and TNFα were similar in both groups. RANKL was lower in GDM subjects (p = 0.019). Contrary to previous reports in the literature, we found a lower serum RANKL level in women with GDM. Further investigation is needed to determine whether there are suitable serum markers for diagnosing GDM or determining prognosis or severity.

5.
Diabetes Technol Ther ; 20(8): 517-523, 2018 08.
Artigo em Inglês | MEDLINE | ID: mdl-29990438

RESUMO

BACKGROUND: Gestational tight glycemic control is critical for women with type 1 diabetes (T1D). Limited data exist on the adoption and retention of diabetes technologies among women in different parity strata. METHODS: We compared T1D management between T1D Exchange clinic registry participants (mean age 28 ± 9 years, 84% white non-Hispanic, and median T1D duration 13 years) who were pregnant at enrollment or year 1 follow-up ("recently pregnant" between 2010 and 2013, n = 214), ever (but not recently) pregnant (n = 1540), and never pregnant (n = 2586). We examined self-reported maternal and fetal outcomes in 130 women who delivered a baby within the last year. RESULTS: Recently pregnant women had the lowest hemoglobin A1c (6.5% pregnant vs. 7.8% ever pregnant vs. 8.0% never pregnant, P < 0.001). Recently pregnant women reported the highest use of continuous subcutaneous insulin infusion (74% vs. 60% vs. 58%, adjusted P < 0.001) and continuous glucose monitor (CGM) (36% vs.17% vs. 12%, adjusted P < 0.001) therapies compared with ever or never pregnant women, respectively, after adjusting for age, diabetes duration, and socioeconomic status. Among women 18-25 years old, CGM use was highest among recently pregnant women (adjusted P = 0.0022). Never pregnant women 26-45 years old had a higher use of CGM compared with younger counterparts (adjusted P < 0.001). Adverse maternal and fetal outcomes were common. CONCLUSIONS: Despite high uptake levels of advanced diabetes technologies among pregnant women, rates of adverse maternal and fetal outcomes remain high. More studies are needed to determine how these technologies could be best used in pregnancy and postpartum to improve health outcomes among women with T1D.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Sistemas de Infusão de Insulina , Insulina/uso terapêutico , Gravidez em Diabéticas/tratamento farmacológico , Adolescente , Adulto , Diabetes Mellitus Tipo 1/sangue , Gerenciamento Clínico , Feminino , Hemoglobina A Glicada/análise , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Gravidez , Gravidez em Diabéticas/sangue , Sistema de Registros , Resultado do Tratamento , Adulto Jovem
6.
Diabetes Technol Ther ; 20(5): 335-343, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-29658779

RESUMO

BACKGROUND: Initial Food and Drug Administration-approved artificial pancreas (AP) systems will be hybrid closed-loop systems that require prandial meal announcements and will not eliminate the burden of premeal insulin dosing. Multiple model probabilistic predictive control (MMPPC) is a fully closed-loop system that uses probabilistic estimation of meals to allow for automated meal detection. In this study, we describe the safety and performance of the MMPPC system with announced and unannounced meals in a supervised hotel setting. RESEARCH DESIGN AND METHODS: The Android phone-based AP system with remote monitoring was tested for 72 h in six adults and four adolescents across three clinical sites with daily exercise and meal challenges involving both three announced (manual bolus by patient) and six unannounced (no bolus by patient) meals. Safety criteria were predefined. Controller aggressiveness was adapted daily based on prior hypoglycemic events. RESULTS: Mean 24-h continuous glucose monitor (CGM) was 157.4 ± 14.4 mg/dL, with 63.6 ± 9.2% of readings between 70 and 180 mg/dL, 2.9 ± 2.3% of readings <70 mg/dL, and 9.0 ± 3.9% of readings >250 mg/dL. Moderate hyperglycemia was relatively common with 24.6 ± 6.2% of readings between 180 and 250 mg/dL, primarily within 3 h after a meal. Overnight mean CGM was 139.6 ± 27.6 mg/dL, with 77.9 ± 16.4% between 70 and 180 mg/dL, 3.0 ± 4.5% <70 mg/dL, 17.1 ± 14.9% between 180 and 250 mg/dL, and 2.0 ± 4.5%> 250 mg/dL. Postprandial hyperglycemia was more common for unannounced meals compared with announced meals (4-h postmeal CGM 197.8 ± 44.1 vs. 140.6 ± 35.0 mg/dL; P < 0.001). No participants met safety stopping criteria. CONCLUSIONS: MMPPC was safe in a supervised setting despite meal and exercise challenges. Further studies are needed in a less supervised environment.


Assuntos
Glicemia/análise , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Pâncreas Artificial , Adolescente , Adulto , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/sangue , Feminino , Humanos , Hipoglicemiantes/administração & dosagem , Insulina/administração & dosagem , Masculino , Resultado do Tratamento , Adulto Jovem
7.
Diabetes Technol Ther ; 20(3): 197-206, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29381090

RESUMO

BACKGROUND: Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS: PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion. RESULTS: Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%-9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over the total glucose range of 40-400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor. CONCLUSIONS: The PRECISE II trial demonstrated that the Eversense CGM system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile.


Assuntos
Automonitorização da Glicemia/instrumentação , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Adulto , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Desenho de Equipamento , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes
8.
Diabetes Technol Ther ; 19(9): 527-532, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28767276

RESUMO

OBJECTIVE: A fully closed-loop insulin-only system was developed to provide glucose control in patients with type 1 diabetes without requiring announcement of meals or activity. Our goal was to assess initial safety and efficacy of this system. RESEARCH DESIGN AND METHODS: The multiple model probabilistic controller (MMPPC) anticipates meals when the patient is awake. The controller used the subject's basal rates and total daily insulin dose for initialization. The system was tested at two sites on 10 patients in a 30-h inpatient study, followed by 15 subjects at three sites in a 54-h supervised hotel study, where the controller was challenged by exercise and unannounced meals. The system was implemented on the UVA DiAs system using a Roche Spirit Combo Insulin Pump and a Dexcom G4 Continuous Glucose Monitor. RESULTS: The mean overall (24-h basis) and nighttime (11 PM-7 AM) continuous glucose monitoring (CGM) values were 142 and 125 mg/dL during the inpatient study. The hotel study used a different daytime tuning and manual announcement, instead of automatic detection, of sleep and wake periods. This resulted in mean overall (24-h basis) and nighttime CGM values of 152 and 139 mg/dL for the hotel study and there was also a reduction in hypoglycemia events from 1.6 to 0.91 events/patient/day. CONCLUSIONS: The MMPPC system achieved a mean glucose that would be particularly helpful for people with an elevated A1c as a result of frequent missed meal boluses. Current full closed loop has a higher risk for hypoglycemia when compared with algorithms using meal announcement.


Assuntos
Diabetes Mellitus Tipo 1/terapia , Hiperglicemia/prevenção & controle , Hipoglicemia/prevenção & controle , Refeições , Pâncreas Artificial/efeitos adversos , Acelerometria , Atividades Cotidianas , Adulto , Algoritmos , Glicemia/análise , Diabetes Mellitus Tipo 1/sangue , Exercício , Estudos de Viabilidade , Feminino , Seguimentos , Hospitalização , Humanos , Hipoglicemia/epidemiologia , Hipoglicemia/etiologia , Masculino , Teste de Materiais , Risco , Lanches , Estados Unidos/epidemiologia , Adulto Jovem
9.
J Clin Endocrinol Metab ; 102(10): 3674-3682, 2017 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-28666360

RESUMO

Context: Closed-loop control (CLC) for the management of type 1 diabetes (T1D) is a novel method for optimizing glucose control, and strategies for individualized implementation are being developed. Objective: To analyze glycemic control in an overnight CLC system designed to "reset" the patient to near-normal glycemic targets every morning. Design: Randomized, crossover, multicenter clinical trial. Participants: Forty-four subjects with T1D requiring insulin pump therapy. Intervention: Sensor-augmented pump therapy (SAP) at home vs 5 nights of CLC (active from 23:00 to 07:00) in a supervised outpatient setting (research house or hotel), with a substudy of 5 nights of CLC subsequently at home. Main Outcome Measure: The percentage of time spent in the target range (70 to 180 mg/dL measured using a continuous glucose monitor). Results: Forty subjects (age, 45.5 ± 9.5 years; hemoglobin A1c, 7.4% ± 0.8%) completed the study. The time in the target range (70 to 180 mg/dL) significantly improved in CLC vs SAP over 24 hours (78.3% vs 71.4%; P = 0.003) and overnight (85.7% vs 67.6%; P < 0.001). The time spent in a hypoglycemic range (<70 mg/dL) decreased significantly in the CLC vs SAP group over 24 hours (2.5% vs 4.3%; P = 0.002) and overnight (0.9% vs 3.2%; P < 0.001). The mean glucose level at 07:00 was lower with CLC than with SAP (123.7 vs 145.3 mg/dL; P < 0.001). The substudy at home, involving 10 T1D subjects, showed similar trends with an increased time in target (70 to 180 mg/dL) overnight (75.2% vs 62.2%; P = 0.07) and decreased time spent in the hypoglycemic range (<70 mg/dL) overnight in CLC vs SAP (0.6% vs 3.7%; P = 0.03). Conclusion: Overnight-only CLC increased the time in the target range over 24 hours and decreased the time in hypoglycemic range over 24 hours in a supervised outpatient setting. A pilot extension study at home showed a similar nonsignificant trend.


Assuntos
Glicemia/efeitos dos fármacos , Ritmo Circadiano , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Adulto , Glicemia/análise , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Ritmo Circadiano/efeitos dos fármacos , Estudos Cross-Over , Diabetes Mellitus Tipo 1/sangue , Feminino , Hemoglobina A Glicada , Humanos , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Adulto Jovem
10.
Processes (Basel) ; 4(4)2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30740333

RESUMO

The development of a closed-loop artificial pancreas to regulate the blood glucose concentration of individuals with type 1 diabetes has been a focused area of research for over 50 years, with rapid progress during the past decade. The daily control challenges faced by someone with type 1 diabetes include asymmetric objectives and risks, and one-sided manipulated input action with frequent relatively fast disturbances. The major automation steps toward a closed-loop artificial pancreas include (i) monitoring and overnight alarms for hypoglycemia (low blood glucose); (ii) overnight low glucose suspend (LGS) systems to prevent hypoglycemia; and (iii) fully closed-loop systems that adjust insulin (and perhaps glucagon) to maintain desired blood glucose levels day and night. We focus on the steps that we used to develop and test a probabilistic, risk-based, model predictive control strategy for a fully closed-loop artificial pancreas. We complete the paper by discussing ramifications of lessons learned for chemical process systems applications.

11.
Endocr Pract ; 12(1): 43-7, 2006.
Artigo em Inglês | MEDLINE | ID: mdl-16524862

RESUMO

OBJECTIVE: To report the successful management of thyrotoxicosis in a seriously ill 47-year-old man with a perforated gastric ulcer in whom oral intake was contraindicated. METHODS: Our patient was treated with 400 mg of propylthiouracil (PTU) every 6 hours in the form of specially prepared suppositories for rectal administration, together with intravenously infused esmolol. RESULTS: We were able to demonstrate substantial absorption of PTU administered by means of rectal suppositories. Serum levels of PTU were maintained within the high therapeutic range for 5 days until the patient was able to tolerate orally administered therapy. The patient improved clinically during this treatment. CONCLUSION: This case strongly supports the rectal administration of PTU in suppository form as an appropriate alternative route in any patient with thyrotoxicosis, including the critically ill patient, when oral administration is not possible.


Assuntos
Úlcera Péptica Perfurada/diagnóstico , Propiltiouracila/administração & dosagem , Úlcera Gástrica/complicações , Tireotoxicose/tratamento farmacológico , Administração Retal , Estado Terminal , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Úlcera Gástrica/diagnóstico , Supositórios , Tireotoxicose/diagnóstico , Resultado do Tratamento
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