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1.
N Engl J Med ; 387(13): 1161-1172, 2022 09 29.
Artículo en Inglés | MEDLINE | ID: mdl-36170500

RESUMEN

BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group. CONCLUSIONS: In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313.).


Asunto(s)
Diabetes Mellitus Tipo 1 , Hipoglucemiantes , Insulina Aspart , Sistemas de Infusión de Insulina , Insulina Lispro , Adolescente , Adulto , Anciano , Biónica/instrumentación , Glucemia/análisis , Automonitorización de la Glucosa Sanguínea/instrumentación , Automonitorización de la Glucosa Sanguínea/métodos , Niño , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hemoglobina Glucada/análisis , Humanos , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Insulina/administración & dosificación , Insulina/efectos adversos , Insulina/uso terapéutico , Insulina Aspart/administración & dosificación , Insulina Aspart/efectos adversos , Insulina Aspart/uso terapéutico , Sistemas de Infusión de Insulina/efectos adversos , Insulina Lispro/administración & dosificación , Insulina Lispro/efectos adversos , Insulina Lispro/uso terapéutico , Persona de Mediana Edad , Adulto Joven
2.
Clin Diabetes ; 41(2): 198-207, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37092165

RESUMEN

Advances in insulin delivery technologies have led to the development of tubeless "patch" systems; however, these devices still involve a level of complexity. We surveyed individuals with type 1 or type 2 diabetes to explore their attitudes and satisfaction after using the CeQur Simplicity insulin patch (SIP) for 2 months. Transition to the SIP yielded significant increases in respondents' overall treatment satisfaction, less diabetes burden, and improvements in psychological well-being compared with respondents' prior insulin delivery method.

3.
Gastroenterology ; 161(3): 1030-1042.e8, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34416976

RESUMEN

Nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) are common conditions with a rising burden. Yet there are significant management gaps between clinical guidelines and practice in patients with NAFLD and NASH. Further, there is no single global guiding strategy for the management of NAFLD and NASH. The American Gastroenterological Association, in collaboration with 7 professional associations, convened an international conference comprising 32 experts in gastroenterology, hepatology, endocrinology, and primary care providers from the United States, Europe, Asia, and Australia. Conference content was informed by the results of a national NASH Needs Assessment Survey. The participants reviewed and discussed published literature on global burden, screening, risk stratification, diagnosis, and management of individuals with NAFLD, including those with NASH. Participants identified promising approaches for clinical practice and prepared a comprehensive, unified strategy for primary care providers and relevant specialists encompassing the full spectrum of NAFLD/NASH care. They also identified specific high-yield targets for clinical research and called for a unified, international public health response to NAFLD and NASH.


Asunto(s)
Epidemias , Gastroenterología/normas , Salud Global/normas , Necesidades y Demandas de Servicios de Salud/normas , Evaluación de Necesidades/normas , Enfermedad del Hígado Graso no Alcohólico , Consenso , Humanos , Enfermedad del Hígado Graso no Alcohólico/diagnóstico , Enfermedad del Hígado Graso no Alcohólico/epidemiología , Enfermedad del Hígado Graso no Alcohólico/terapia , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo
4.
Diabetes Spectr ; 34(1): 7-19, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33627989

RESUMEN

In September 2019, the U.S. Food and Drug Administration approved oral semaglutide as the first orally administered glucagon-like peptide 1 (GLP-1) receptor agonist for treating people with type 2 diabetes. Although injectable GLP-1 receptor agonists are well-established treatment options for people with type 2 diabetes, clinical experience with an oral formulation in this class is limited. This article provides practical guidance for diabetes care and education specialists on how to effectively counsel patients initiating therapy with oral semaglutide on appropriate administration of the treatment and its possible effects on glycemic control, body weight, and quality of life. Strategies for mitigating potential side effects typical of the GLP-1 receptor agonist class, namely nausea, vomiting, and diarrhea, are also provided. Involving patients in treatment decisions and educating them about available and prescribed medications are key strategies for encouraging treatment adherence and ensuring optimal therapeutic outcomes.

5.
Clin Diabetes ; 39(1): 72-79, 2021 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33551556

RESUMEN

Continuous subcutaneous insulin infusion (CSII) treatment may improve long-term glycemic outcomes and enhance quality of life compared with a multiple daily injection (MDI) insulin regimen for people with type 1 diabetes. As the number of people treated with CSII via a tubeless insulin pump is increasing, there is growing interest in the long-term glycemic outcomes of this treatment option across diverse populations. This multicenter, retrospective study evaluated glycemic control in 156 adults with type 1 diabetes initiating tubeless insulin pump therapy following transition from either MDI or CSII with a tubed insulin pump. In this study, use of the tubeless insulin pump over 12 months was associated with significant improvement in A1C in adults with type 1 diabetes, most notably in those with an A1C ≥9.0% and those previously treated with MDI.

6.
JAMA ; 325(22): 2262-2272, 2021 06 08.
Artículo en Inglés | MEDLINE | ID: mdl-34077499

RESUMEN

Importance: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied. Objective: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices. Design, Setting, and Participants: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications. Interventions: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59). Main Outcomes and Measures: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months. Results: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group. Conclusions and Relevance: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months. Trial Registration: ClinicalTrials.gov Identifier: NCT03566693.


Asunto(s)
Glucemia/análisis , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Control Glucémico/métodos , Hipoglucemiantes/uso terapéutico , Insulina/uso terapéutico , Anciano , Intervalos de Confianza , Diabetes Mellitus Tipo 2/sangre , Femenino , Hemoglobina Glucada/análisis , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Periodo Posprandial , Tamaño de la Muestra , Factores de Tiempo , Resultado del Tratamiento
7.
Lancet ; 393(10176): 1138-1148, 2019 Mar 16.
Artículo en Inglés | MEDLINE | ID: mdl-30808512

RESUMEN

BACKGROUND: Insulin therapy is most effective if dosage titrations are done regularly and frequently, which is seldom practical for most clinicians, resulting in an insulin titration gap. The d-Nav Insulin Guidance System (Hygieia, Livonia, MI, USA) is a handheld device that is used to measure glucose, determine glucose patterns, and automatically determine the appropriate next insulin dose. We aimed to determine whether the combination of the d-Nav device and health-care professional support is superior to health-care professional support alone. METHODS: In this multicentre, randomised, controlled study, we recruited patients from three diabetes centres in the USA (in Detroit MI; Minneapolis, MN; and Des Moines IA). Patients were eligible if they were aged 21-70 years, diagnosed with type 2 diabetes with a glycated haemoglobin (HbA1c) concentration of 7·5% or higher (≥58 mmol/mol) and 11% or lower (≤97 mmol/mol), and had been using the same insulin regimen for the previous 3 months. Exclusion criteria included body-mass index of 45 kg/m2 or higher; severe cardiac, hepatic, or renal impairment; and more than two severe hypoglycaemic events in the past year. Eligible participants were randomly assigned (1:1), with randomisation blocked within each site, to either d-Nav and health-care professional support (intervention group) or health-care professional support alone (control group). Both groups were contacted seven times (three face-to-face and four phone visits) during 6 months of follow-up. The primary objective was to compare average change in HbA1c from baseline to 6 months. Safety was assessed by the frequency of hypoglycaemic events. The primary objective and safety were assessed in the intention-to-treat population. We used Student's t test to assess the primary outcome for statistical significance. This study was registered with ClinicalTrials.gov, number NCT02424500. FINDINGS: Between Feb 2, 2015, and March 17, 2017, 236 patients were screened for eligibility, of whom 181 (77%) were enrolled and randomly assigned to the intervention (n=93) and control (n=88) groups. At baseline, mean HbA1c was 8·7% (SD 0·8; 72 mmol/mol [SD 8·8]) in the intervention group and 8·5% (SD 0·8; 69 mmol/mol [SD 8·8]) in the control group. The mean decrease in HbA1c from baseline to 6 months was 1·0% (SD 1·0; 11 mmol/mol [SD 11]) in the intervention group, and 0·3% (SD 0·9; 3·3 mmol/mol [9·9]) in the control group (p<0·0001). The frequency of hypoglycaemic events per month was similar between the groups (0·29 events per month [SD 0·48] in the intervention group vs 0·29 [SD 1·12] in the control group; p=0·96). INTERPRETATION: The combination of automated insulin titration guidance with support from health-care professionals offers superior glycaemic control compared with support from health-care professionals alone. Such a solution facilitated safe and effective insulin titration in a large group of patients with type 2 diabetes, and now needs to be evaluated across large health-care systems to confirm these findings and study cost-effectiveness. FUNDING: US National Institutes of Health, National Institute of Digestive and Kidney Diseases.


Asunto(s)
Glucemia/efectos de los fármacos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Sistemas de Liberación de Medicamentos/instrumentación , Hemoglobina Glucada/metabolismo , Insulina/uso terapéutico , Administración del Tratamiento Farmacológico/tendencias , Anciano , Diabetes Mellitus Tipo 2/epidemiología , Femenino , Hemoglobina Glucada/análisis , Personal de Salud , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemia/epidemiología , Hipoglucemiantes/uso terapéutico , Insulina/administración & dosificación , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento
8.
Clin Diabetes ; 38(4): 348-356, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-33132504

RESUMEN

Continuous glucose monitoring (CGM) provides comprehensive assessment of daily glucose measurements for patients with diabetes and can reveal high and low blood glucose values that may occur even when a patient's A1C is adequately controlled. Among the measures captured by CGM, the percentage of time in the target glycemic range, or "time in range" (typically 70-180 mg/dL), has emerged as one of the strongest indicators of good glycemic control. This review examines the shift to using CGM to assess glycemic control and guide diabetes treatment decisions, with a focus on time in range as the key metric of glycemic control.

9.
JAMA ; 323(23): 2397-2406, 2020 06 16.
Artículo en Inglés | MEDLINE | ID: mdl-32543682

RESUMEN

Importance: Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. Objective: To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. Design, Setting, and Participants: Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. Interventions: Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). Main Outcomes and Measures: The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. Results: Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8). Conclusions and Relevance: Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT03240432.


Asunto(s)
Automonitorización de la Glucosa Sanguínea/métodos , Glucemia/análisis , Diabetes Mellitus Tipo 1/sangre , Hemoglobina Glucada/análisis , Hipoglucemia/prevención & control , Anciano , Automonitorización de la Glucosa Sanguínea/instrumentación , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Diabetes Mellitus Tipo 1/psicología , Femenino , Humanos , Hiperglucemia/diagnóstico , Hipoglucemia/inducido químicamente , Hipoglucemia/diagnóstico , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Masculino , Persona de Mediana Edad , Monitoreo Ambulatorio/instrumentación , Medición de Resultados Informados por el Paciente
10.
Clin Diabetes ; 37(1): 57-64, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30705498

RESUMEN

IN BRIEF Glucose variability is a potential independent risk factor of poor clinical outcome among people with diabetes, with adequate measurement technically difficult and cumbersome. For this study, a novel 14-day continuous sensor was used to assess glucose variability among people with type 2 diabetes (T2D). The aim was to characterize glucose profiles for up to 2 weeks in T2D and to survey device utilization in a standard clinical setting and its potential to collect clinically meaningful data.

11.
Ann Intern Med ; 167(6): 365-374, 2017 09 19.
Artículo en Inglés | MEDLINE | ID: mdl-28828487

RESUMEN

Background: Continuous glucose monitoring (CGM), which studies have shown is beneficial for adults with type 1 diabetes, has not been well-evaluated in those with type 2 diabetes receiving insulin. Objective: To determine the effectiveness of CGM in adults with type 2 diabetes receiving multiple daily injections of insulin. Design: Randomized clinical trial. (The protocol also included a type 1 diabetes cohort in a parallel trial and subsequent second trial.) (ClinicalTrials.gov: NCT02282397). Setting: 25 endocrinology practices in North America. Patients: 158 adults who had had type 2 diabetes for a median of 17 years (interquartile range, 11 to 23 years). Participants were aged 35 to 79 years (mean, 60 years [SD, 10]), were receiving multiple daily injections of insulin, and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9% (mean, 8.5%). Intervention: Random assignment to CGM (n = 79) or usual care (control group, n = 79). Measurements: The primary outcome was HbA1c reduction at 24 weeks. Results: Mean HbA1c levels decreased to 7.7% in the CGM group and 8.0% in the control group at 24 weeks (adjusted difference in mean change, -0.3% [95% CI, -0.5% to 0.0%]; P = 0.022). The groups did not differ meaningfully in CGM-measured hypoglycemia or quality-of-life outcomes. The CGM group averaged 6.7 days (SD, 0.9) of CGM use per week. Limitation: 6-month follow-up. Conclusion: A high percentage of adults who received multiple daily insulin injections for type 2 diabetes used CGM on a daily or near-daily basis for 24 weeks and had improved glycemic control. Because few insulin-treated patients with type 2 diabetes currently use CGM, these results support an additional management method that may benefit these patients. Primary Funding Source: Dexcom.


Asunto(s)
Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Adulto , Anciano , Proteínas Bacterianas , Diabetes Mellitus Tipo 2/sangre , Esquema de Medicación , Hemoglobina Glucada/metabolismo , Humanos , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Proteínas de la Membrana , Persona de Mediana Edad , Satisfacción del Paciente , Calidad de Vida
12.
Ann Intern Med ; 167(2): 95-102, 2017 07 18.
Artículo en Inglés | MEDLINE | ID: mdl-28605777

RESUMEN

Background: Debate exists as to whether the higher hemoglobin A1c (HbA1c) levels observed in black persons than in white persons are due to worse glycemic control or racial differences in the glycation of hemoglobin. Objective: To determine whether a racial difference exists in the relationship of mean glucose and HbA1c. Design: Prospective, 12-week observational study. Setting: 10 diabetes centers in the United States. Participants: 104 black persons and 104 white persons aged 8 years or older who had had type 1 diabetes for at least 2 years and had an HbA1c level of 6.0% to 12.0%. Measurements: Mean glucose concentration, measured by using continuous glucose monitoring and compared by race with HbA1c, glycated albumin, and fructosamine values. Results: The mean HbA1c level was 9.1% in black persons and 8.3% in white persons. For a given HbA1c level, the mean glucose concentration was significantly lower in black persons than in white persons (P = 0.013), which was reflected in mean HbA1c values in black persons being 0.4 percentage points (95% CI, 0.2 to 0.6 percentage points) higher than those in white persons for a given mean glucose concentration. In contrast, no significant racial differences were found in the relationship of glycated albumin and fructosamine levels with the mean glucose concentration (P > 0.20 for both comparisons). Limitation: There were too few participants with HbA1c levels less than 6.5% to generalize the results to such individuals. Conclusion: On average, HbA1c levels overestimate the mean glucose concentration in black persons compared with white persons, possibly owing to racial differences in the glycation of hemoglobin. However, because race only partially explains the observed HbA1c differences between black persons and white persons, future research should focus on identifying and modifying barriers impeding improved glycemic control in black persons with diabetes. Primary Funding Source: Helmsley Charitable Trust.


Asunto(s)
Población Negra , Glucemia/metabolismo , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/etnología , Hemoglobina Glucada/metabolismo , Población Blanca , Adolescente , Adulto , Automonitorización de la Glucosa Sanguínea , Niño , Femenino , Fructosamina/sangre , Productos Finales de Glicación Avanzada , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Albúmina Sérica/metabolismo , Estados Unidos , Adulto Joven , Albúmina Sérica Glicada
13.
Diabetes Spectr ; 31(1): 105-112, 2018 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-29456434

RESUMEN

EDITOR'S NOTE: This article is adapted from the address Ms. Kruger delivered as the recipient of the American Diabetes Association's Outstanding Educator in Diabetes Award for 2017. She delivered the address in June 2017 at the Association's 77th Annual Meeting and Scientific Sessions in San Diego, Calif. A webcast of the speech can be viewed on ADA's DiabetesPro website at https://professional.diabetes.org/webcasts-ss2017.

14.
Clin Diabetes ; 36(2): 149-159, 2018 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-29686454

RESUMEN

IN BRIEF Novel co-formulations of basal insulin analogs and glucagon-like peptide-1 (GLP-1) receptor agonists have provided new options for patients with type 2 diabetes who are not reaching recommended glycemic targets. The components of currently available co-formulations (insulin degludec/ liraglutide [IDegLira,] and insulin glargine U100/lixisenatide [iGlarLixi]) act synergistically to address multiple pathophysiologic defects while minimizing the side effects associated with either component when used alone. In Europe, these products are approved for use in patients on regimens of one or more oral antidiabetic drugs; in the United States, they are indicated for use as an adjunct to diet and exercise in patients with type 2 diabetes inadequately controlled with either basal insulin or their respective GLP-1 receptor agonist component. This article reviews key clinical trials in which these products were initiated in insulin-naive patients and describes how they can be safely and effectively titrated in clinical practice.

17.
JAMA ; 317(4): 371-378, 2017 01 24.
Artículo en Inglés | MEDLINE | ID: mdl-28118453

RESUMEN

Importance: Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection. Objective: To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections. Design, Setting, and Participants: Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9%. Interventions: Random assignment 2:1 to CGM (n = 105) or usual care (control group; n = 53). Main Outcomes and Measures: Primary outcome measure was the difference in change in central-laboratory-measured HbA1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70 mg/dL, measured with CGM for 7 days at 12 and 24 weeks. Results: Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44% women; mean baseline HbA1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA1c reduction from baseline was 1.1% at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5% and 0.4%, respectively, in the control group (repeated-measures model P < .001). At 24 weeks, the adjusted treatment-group difference in mean change in HbA1c level from baseline was -0.6% (95% CI, -0.8% to -0.3%; P < .001). Median duration of hypoglycemia at less than <70 mg/dL was 43 min/d (IQR, 27-69) in the CGM group vs 80 min/d (IQR, 36-111) in the control group (P = .002). Severe hypoglycemia events occurred in 2 participants in each group. Conclusions and Relevance: Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects. Trial Registration: clinicaltrials.gov Identifier: NCT02282397.


Asunto(s)
Automonitorización de la Glucosa Sanguínea/instrumentación , Glucemia/análisis , Diabetes Mellitus Tipo 1/sangre , Diabetes Mellitus Tipo 1/tratamiento farmacológico , Hemoglobina Glucada/análisis , Hipoglucemiantes/administración & dosificación , Insulina/administración & dosificación , Adulto , Anciano , Automonitorización de la Glucosa Sanguínea/psicología , Automonitorización de la Glucosa Sanguínea/estadística & datos numéricos , Esquema de Medicación , Femenino , Humanos , Hiperglucemia/sangre , Hiperglucemia/tratamiento farmacológico , Hipoglucemia/sangre , Hipoglucemia/inducido químicamente , Hipoglucemiantes/efectos adversos , Insulina/efectos adversos , Masculino , Persona de Mediana Edad , Evaluación de Resultado en la Atención de Salud , Satisfacción del Paciente , Factores de Tiempo
18.
Gastroenterology ; 149(2): 330-9, 2015 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-25980755

RESUMEN

BACKGROUND & AIMS: After the Diabetes Control and Complications Trial (DCCT), the Epidemiology of Diabetes Interventions and Complications (EDIC) study continued to show persistent benefit of prior intensive therapy on neuropathy, retinopathy, and nephropathy in type 1 diabetes mellitus (DM). The relationship between control of glycemia and gastric emptying (GE) is unclear. METHODS: We assessed GE with a (13)C-spirulina breath test and symptoms in 78 participants with type 1 diabetes at year 20 of EDIC. The relationship between delayed GE and glycated hemoglobin (HbA1c), complications of DM, and gastrointestinal symptoms were evaluated. RESULTS: GE was normal (37 participants; 50%), delayed (35 participants; 47%), or rapid (2 participants; 3%). The latest mean HbA1c was 7.7%. In univariate analyses, delayed GE was associated with greater DCCT baseline HbA1c and duration of DM before DCCT (P ≤ .04), greater mean HbA1c over an average of 27 years of follow-up evaluation (during DCCT-EDIC, P = .01), lower R-R variability during deep breathing (P = .03) and severe nephropathy (P = .05), and a greater composite upper gastrointestinal symptom score (P < .05). In multivariate models, retinopathy was the only complication of DM associated with delayed GE. Separately, DCCT baseline HbA1c (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1-2.3) and duration of DM (OR, 1.2; 95% CI, 1.01-1.3) before DCCT entry and mean HbA1c during DCCT-EDIC (OR, 2.2; 95% CI, 1.04-4.5) were associated independently with delayed GE. CONCLUSIONS: In the DCCT/EDIC study, delayed GE was remarkably common and associated with gastrointestinal symptoms and with measures of early and long-term hyperglycemia. ClinicalTrials.gov numbers NCT00360815 and NCT00360893.


Asunto(s)
Diabetes Mellitus Tipo 1/complicaciones , Vaciamiento Gástrico , Gastroparesia/epidemiología , Hiperglucemia/epidemiología , Glucemia , Estudios de Casos y Controles , Diabetes Mellitus Tipo 1/sangre , Femenino , Gastroparesia/etiología , Hemoglobina Glucada/análisis , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Factores de Tiempo
19.
Clin Diabetes ; 34(1): 34-43, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26807007

RESUMEN

In Brief This article explores some of the reasons for the delay in insulin initiation in primary care and evaluates new approaches to insulin therapy that may address these barriers and, therefore, improve insulin use by primary care providers.

20.
Postgrad Med ; 136(3): 246-254, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38497381

RESUMEN

Use of innovative technologies such as continuous glucose monitoring (CGM) and insulin delivery systems have been shown to be safe and effective in helping patients with diabetes achieve significantly improved glycemic outcomes compared to their previous therapies. However, these technologies are underutilized in many primary care practices. This narrative review discusses some of the clinical and economic benefits of tubeless insulin delivery devices and discusses how this technology can overcome the main obstacles inherent to use of conventional insulin delivery devices.


Asunto(s)
Automonitorización de la Glucosa Sanguínea , Diabetes Mellitus Tipo 2 , Hipoglucemiantes , Sistemas de Infusión de Insulina , Insulina , Humanos , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/sangre , Insulina/administración & dosificación , Insulina/uso terapéutico , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/uso terapéutico , Automonitorización de la Glucosa Sanguínea/métodos , Glucemia/análisis
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