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PURPOSE OF REVIEW: While preliminary evidence for use of real-time continuous glucose monitoring (rtCGM) in the hospital setting is encouraging, challenges with currently available devices and technology will need to be overcome as part of real-world integration. This paper reviews the current evidence and guidelines regarding use of rtCGM in the hospital and suggests a practical approach to implementation. RECENT FINDINGS: There is now a considerable body of real-world evidence on the benefits of reducing dysglycemia in the hospital using both traditional point-of-care (POC) glucose testing and rtCGM. Benefits of rtCGM include decreased frequency of hypo- and hyperglycemia with reduced need of frequent POC checks and it is both feasible and well-accepted by nursing staff and providers. If expansion to additional sites is to be considered, practical solutions will need to be offered. Recommendations for an operational workflow and tools are described to guide implementation in the non-ICU setting. Further testing in randomized controlled trials and real-world dissemination and implementation designs is needed, together with industry and technology collaborations, to further streamline the integration into health systems.
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OBJECTIVE: This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance-based health system (Scripps Health). RESEARCH DESIGN AND METHODS: A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). RESULTS: All clinical outcomes improved significantly over 1 year in the overall sample (P < 0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. CONCLUSIONS: This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings.
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Diabetes Mellitus Tipo 2 , Tutoria , Atenção Primária à Saúde , Humanos , Diabetes Mellitus Tipo 2/terapia , Masculino , Feminino , Pessoa de Meia-Idade , Tutoria/métodos , Idoso , Adulto , Hemoglobinas Glicadas/metabolismo , Pessoal Técnico de SaúdeRESUMO
AIMS: Insulin efsitora alfa (efsitora) is a once-weekly basal insulin. This review describes the study design and rationale of the efsitora phase 3 Once Weekly (QW) Insulin Therapy (QWINT) clinical development programme, including the five trials, QWINT-1 through QWINT-5. MATERIALS AND METHODS: The five trials included insulin-naïve adults (QWINT-1 and -2) with type 2 diabetes (T2D), adults with T2D previously treated with basal insulin (QWINT-3 and -4), and QWINT-5 in adults with type 1 diabetes. All five trials were designed as multicentre, randomized, controlled, open-label, treat-to-target studies to investigate the efficacy and safety of efsitora versus active once-daily basal insulin comparators (insulin glargine U100 or insulin degludec U100). The primary objective of each trial is to compare the change in HbA1c from baseline to week 26 or 52 between efsitora and the active comparator. The key secondary objectives include change in fasting glucose, insulin dose and continuous glucose monitoring variables, and patient-reported outcome questionnaires. CONCLUSIONS: The QWINT development programme includes a racially and geographically diverse population to provide important information regarding the efficacy and safety of efsitora and its clinical management of people with diabetes.
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Ensaios Clínicos Fase III como Assunto , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Esquema de Medicação , Hipoglicemiantes , Insulina de Ação Prolongada , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/sangue , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/sangue , Insulina de Ação Prolongada/administração & dosagem , Insulina de Ação Prolongada/uso terapêutico , Glicemia/efeitos dos fármacos , Glicemia/análise , Hemoglobinas Glicadas/análise , Hemoglobinas Glicadas/efeitos dos fármacos , Adulto , Insulina Glargina/administração & dosagem , Insulina Glargina/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Feminino , Masculino , Projetos de Pesquisa , Insulina/administração & dosagem , Insulina/uso terapêutico , Estudos Multicêntricos como Assunto , Pessoa de Meia-IdadeRESUMO
BACKGROUND: Hispanic individuals have higher type 2 diabetes (T2D) prevalence, poorer outcomes, and are disproportionately affected by COVID-19. Culturally-tailored, diabetes educational text messaging has previously improved HbA1c in this population. METHODS: During the pandemic, hospitalized Hispanic adults with T2D (N = 172) were randomized to receive Dulce Digital-COVID Aware ("DD-CA") texting platform upon discharge plus diabetes transition service (DTS) or DTS alone. DD-CA includes diabetes educational messaging with additional COVID-safe messaging (e.g., promoting masking; social distancing; vaccination). FINDINGS: Among adults with poorly-controlled diabetes (Mean HbA1c = 9.6 ± 2.2 %), DD-CA did not reduce 30- or 90-day readmissions compared to standard care (28 % vs 15 %, p = .06; 37 % vs 35 %, p = .9, respectively). However, the improvement in HbA1c was larger among those in the DD-CA compared to DTS at 3 months (n = 56; -2.69 % vs. -1.45 %, p = .0496) with reduced effect at 6 months (n = 64; -2.03 % vs -0.91 %, p = .07). Low follow-up completion rates and the addition of covariates (to control for baseline group differences that existed despite randomization) impacted statistical power. INTERPRETATION: During the pandemic, DD-CA offered an alternative digital approach to diabetes and COVID education and support for a high-risk Hispanic population and achieved trends toward improvement in glycemic control despite relatively low engagement and not reducing hospital readmissions.
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COVID-19 , Diabetes Mellitus Tipo 2 , Envio de Mensagens de Texto , Adulto , Humanos , COVID-19/epidemiologia , Diabetes Mellitus Tipo 2/epidemiologia , Diabetes Mellitus Tipo 2/terapia , Hemoglobinas Glicadas , Hispânico ou Latino , México/epidemiologia , Alta do Paciente , Estados UnidosRESUMO
OBJECTIVE: This post hoc analysis assessed continuous glucose monitoring (CGM)-based metrics and hypoglycemia duration with once-weekly insulin icodec versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4). RESEARCH DESIGN AND METHODS: Time in range (TIR) (3.9-10.0 mmol/L), time above range (TAR) (>10.0 mmol/L), and time below range (TBR) (<3.9 mmol/L and <3.0 mmol/L) were assessed during three CGM time periods (switch [weeks 0-4], end of treatment [weeks 22-26], and follow-up [weeks 27-31]) for icodec versus comparators (ONWARDS 2, insulin degludec [basal regimen]; ONWARDS 4, insulin glargine U100 [basal-bolus regimen]) using double-blind CGM data. CGM-derived hypoglycemic episode duration (<3.9 mmol/L) was assessed. RESULTS: In both trials, there were no statistically significant differences in TIR, TAR, or TBR (<3.0 mmol/L) for icodec versus comparators across all time periods. In the end-of-treatment period, mean TIR was 63.1% (icodec) vs. 59.5% (degludec) in ONWARDS 2 and 66.9% (icodec) vs. 66.4% (glargine U100) in ONWARDS 4. Mean TBR <3.9 mmol/L and <3.0 mmol/L remained within recommended targets (<4% and <1%, respectively) across time periods and treatment arms. Hypoglycemic episode duration (<3.9 mmol/L) was comparable across time periods and treatment arms (median duration ≤40 min). CONCLUSIONS: In insulin-experienced participants with long-standing type 2 diabetes, CGM-based TIR, TAR, and CGM-derived hypoglycemia duration (<3.9 mmol/L) were comparable for icodec and once-daily basal insulin analogs during all time periods. TBR remained within recommended targets.
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Diabetes Mellitus Tipo 2 , Hipoglicemia , Insulina de Ação Prolongada , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina/uso terapêutico , Hipoglicemiantes/uso terapêutico , Glicemia , Automonitorização da Glicemia , Monitoramento Contínuo da Glicose , Insulina Glargina/uso terapêutico , Insulina Regular HumanaRESUMO
This study used a social-ecological framework to examine predictors of depression, diabetes self-management, and clinical indicators of health risk among Hispanics with type 2 diabetes residing in the United States (U.S.)-Mexico border region in San Diego County, California, United States of America. Important links were observed between greater social-environmental support for disease management and less depression, better diabetes self-management, and lower body mass index and serum triglyceride concentrations. Less depressive symptomatology was also related to lower hemoglobin A1c levels. Findings suggest that programs aiming to improve diabetes self-management and health outcomes in Hispanics with type 2 diabetes should consider multilevel, social, and environmental influences on health, behavior, and emotional well-being.
En este estudio se utilizó un marco socioecológico para analizar los factores predictivos de la depresión, la autogestión de la diabetes y los indicadores clínicos de riesgo para la salud en hispanos que padecen diabetes tipo 2 residentes en la zona fronteriza entre México y los Estados Unidos del Condado de San Diego en California. Se observaron vínculos importantes entre un mayor apoyo socioambiental para el manejo de la enfermedad y una presencia menor de la depresión, una mejor autogestión de la diabetes, y menores índices de masa corporal y concentraciones de triglicéridos séricos. La presencia menor de síntomas depresivos también se relacionó con niveles inferiores de hemoglobina A1c. Estos resultados indican que los programas dirigidos a mejorar la autogestión de la diabetes y los resultados en materia de salud en los hispanos que padecen diabetes tipo 2 deben tener en cuenta las influencias sociales y ambientales sobre la salud, el comportamiento y el bienestar emocional.