Cognitive behavioral therapy delivered via digital mobile application for the treatment of type 2 diabetes: Rationale, design, and baseline characteristics of a randomized, controlled trial.

BACKGROUND: The prevalence of type 2 diabetes (T2D) continues to rise in the United States and worldwide. Cognitive behavioral therapy (CBT) has been shown to improve glycemic control in patients with T2D, but broad implementation has been limited by inherent access and resource constraints. Digital therapeutics have the potential to overcome these obstacles. HYPOTHESIS: To describe the rationale and design of a trial evaluating the efficacy and safety of a digital therapeutic providing CBT to improve glycemic control in adults with T2D. METHODS: This randomized, controlled, multicenter, Phase 3 trial evaluates the hypothesis that BT-001, an investigational digital therapeutic intended to help patients with T2D improve their glycemic control, on top of standard of care therapy, will lower hemoglobin A1c (HbA1c) compared to a control app across a broad range of patients in a real-world setting. The study is designed to provide evidence to support FDA review of this device as a digital therapeutic. The intervention is provided within the digital application (app) and includes no person-to-person coaching. The primary endpoint is the difference in HbA1c change from baseline to 90 days for BT-001-allocated subjects compared with those assigned to the control app. Safety assessment includes adverse events and adverse device effects. The study incorporates pragmatic features including entirely remote conduct with at-home visits for physical measures and blood sample collection. CONCLUSIONS: This randomized, controlled trial evaluates a cognitive behavioral intervention delivered via smartphone app which has the potential to provide a scalable treatment option for patients with T2D.

Emergency management of bleeding associated with old and new oral anticoagulants.

As major prescribers of oral anticoagulants, cardiologists must be familiar with strategies to manage bleeding, the principal complication associated with all anticoagulants, and to reverse anticoagulant effects in acute-care settings. The purpose of this manuscript is to review currently available information regarding dabigatran and rivaroxaban, the 2 novel oral anticoagulants approved to date in the United States. Further, we suggest reasonable interventions for the clinician faced with a patient who suffers a major bleeding event while receiving one of these agents. Data sources were peer-reviewed publications, US Food and Drug Administration documents in the public domain, and approved US prescribing information for dabigatran (Pradaxa) and rivaroxaban (Xarelto). Strategies for management of bleeding and reversal of anticoagulant effects from warfarin include vitamin K, fresh frozen plasma, and prothrombin complex concentrates. For rivaroxaban and dabigatran, appropriate therapies include support and observation, which are likely to be effective for the majority of patients because of the short half-lives of these agents. In severe life-threatening hemorrhage, clotting-factor substitutes may be appropriate in certain situations. Validated protocols specific to each agent remain to be developed.

Hyperglycemia in the critically ill patient.

Hyperglycemia and insulin resistance are common among critically ill patients and occur in patients with or without a history of diabetes mellitus. All patients undergoing critical illness are at risk for stress-induced hyperglycemia. Some patients may be at greater risk for hyperglycemia than others when considering underlying disease states and iatrogenic factors. Many recent studies demonstrate that tight glucose control can decrease morbidity and mortality associated with critical illness. This article reviews the pathophysiology behind stress-induced hyperglycemia, the evidence to support tight glycemic control, and the importance of an intensive insulin therapy protocol to standardize treatment among critical care patients.

Consequences of vancomycin-resistant Enterococcus in liver transplant recipients: a matched control study.

BACKGROUND: Liver transplant recipients are at high risk for multi-drug resistant infections because of broad-spectrum antibiotic and immunosuppression. This study evaluates the clinical and financial impact of vancomycin resistant Enterococcus (VRE) in liver transplant recipients. METHODS: Liver transplant recipients with VRE from 1995 to 2002 were identified and matched (age, gender, UNOS status, liver disease and transplant date) to controls. Demographics, clinical factors, co-infections, antibiotic use, length of stay, abdominal surgeries, biliary complications, survival and resource utilization were compared with matched controls. RESULTS: Nineteen patients were found to have 28 VRE infections via evaluation of microbiologic culture results of all liver transplant patients in the transplant registry. Thirty-eight non-VRE patients served as matched controls. The four most common sites VRE was cultured from included blood (35%), peritoneal fluid (35%), bile (20%), and urine (12%). Median time from transplant to infection was 48 d (range of 4-348). No significant differences in demographics were observed. The VRE group had a higher incidence of prior antibiotic use than the non-VRE group (95% vs. 34%; p < 0.05). The VRE group also experienced more abdominal surgery (20/19 vs. 3/38; p = 0.029), biliary complications (9/19 vs. 9/38; p = 0.018) and a longer length of stay (42.5 vs. 21.7 d; p = .005). Survival in the VRE group was lower (52% vs. 82%; p = 0.048). Six of the 19 VRE patients were treated with linezolid for eight infection episodes, and four of six patients survived. Eight patients were treated with quinupristin/dalfopristin for nine infections, and two of eight survived. Increased cost of care was observed in the VRE group. Laboratory costs were higher in the VRE group (6500 dollars vs. 1750; p = 0.02) as well. CONCLUSION: VRE was associated with prior antibiotic use, multiple abdominal surgeries, biliary complications and resulted in decreased survival compared to non-VRE control patients. VRE patients also utilized more hospital resources. Linezolid showed a trend toward improved survival.

Preliminary report on the safety of heparin for deep venous thrombosis prophylaxis after severe head injury.

BACKGROUND: Prophylaxis for venous thromboembolism (VTE) in head injured patients has avoided heparin products because of concern for exacerbating intracranial bleeding. The purpose of this study was to evaluate the safety of unfractionated heparin (UFH) for VTE prophylaxis after traumatic brain injury. METHODS: We retrospectively evaluated the early use of UFH in patients sustaining a severe closed head injury (Abbreviated Injury Scale score > 3) from January 1, 2000, through December 31, 2000. Two groups were formed on the basis of the timing of UFH administration: within 72 hours of admission (Early group), or after the third day of hospitalization (Late group), if at all. Intracranial bleeding related to UFH administration was assessed by computed tomographic scan of the head and/or clinical examination. RESULTS: Sixty-four of 76 patients with intracranial blood on admission head computed tomographic scan fulfilled study criteria. Seventy-three percent (n = 47) were in the Early group and 27% (n = 17) were in the Late group. None of the Early group had an increase in intracranial bleeding or deterioration on neurologic examination as a result of UFH administration. However, there was no statistical difference in VTE events between the two groups. CONCLUSION: Early use of UFH in the severe head injured patient does not increase bleeding complications.