Holocene ecosystem and temperature development inferred from invertebrate remains in Zminje Jezero (Dinaric Alps, Montenegro).

Unlabelled: Lake Zminje Jezero (1535 m a.s.l.

Development of a plain-language library of educational resources for research participants.

There is a paucity of educational resources for potential clinical trial participants, particularly resources in plain language, attentive to health literacy principles and translated into native languages. The New England Research Subject Advocacy Group was formed to explore common issues, interests, and concerns related to the experience of participation in clinical research and research participant safety. Specifically, the group sought to increase community awareness and trust through the development and distribution of publicly accessible informational resources.

Ethical challenges experienced by clinical research nurses:: A qualitative study.

Background:: Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives (to implement research protocols and advance science), setting (research facilities), and nature of the nurse-participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility.

Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States.

We report the long-term follow-up of the efficacy and safety of islet transplantation in seven type 1 diabetic subjects from the United States enrolled in the multicenter international Edmonton Protocol who had persistent islet function after completion of the Edmonton Protocol. Subjects were followed up to 12 years with serial testing for sustained islet allograft function as measured by C-peptide. All seven subjects demonstrated continued islet function longer than a decade from the time of first islet transplantation.

Insulin secretion and sensitivity in healthy adults with low vitamin D are not affected by high-dose ergocalciferol administration: a randomized controlled trial.

Background: Epidemiologic data suggest that low serum 25-hydroxyvitamin D [25(OH)D] increases insulin resistance and the risk of type 2 diabetes. Few interventional trials have assessed the effect of vitamin D on insulin metabolism, and published results are discordant.

Objective: The goal of this study was to perform a detailed assessment of the effect of ergocalciferol administration on glucose and insulin metabolism in healthy people with low total 25(OH)D(total).

A distributed model: redefining a robust research subject advocacy program at the Harvard Clinical and Translational Science Center.

The Harvard Clinical and Translational Science Center ("Harvard Catalyst") Research Subject Advocacy (RSA) Program has reengineered subject advocacy, distributing the delivery of advocacy functions through a multi-institutional, central platform rather than vesting these roles and responsibilities in a single individual functioning as a subject advocate. The program is process-oriented and output-driven, drawing on the strengths of participating institutions to engage local stakeholders both in the protection of research subjects and in advocacy for subjects' rights. The program engages stakeholder communities in the collaborative development and distributed delivery of accessible and applicable educational programming and resources.

Continuing improvement in type 2 diabetes care through performance-based evaluations.

Aims: The timely evidence-based care of type 2 diabetes mellitus (T2DM) is imperative for achieving and maintaining glycemic control, reducing complications, and changing the paradigm of this epidemic. Based largely on results from earlier performance improvement (PI) activities, we conducted a continuing medical education (CME)-certified PI activity to foster improved adherence to guideline recommendations and current evidence for the care of patients with T2DM.

Methods: Participants engaged in a 3-stage process of self-assessment, goal setting, and reassessment.

A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes.

Objective: To test cognitive behavioral therapy for adherence and depression (CBT-AD) in type 2 diabetes. We hypothesized that CBT-AD would improve adherence; depression; and, secondarily, hemoglobin A1c (A1C).

Research Design And Methods: Eighty-seven adults with unipolar depression and uncontrolled type 2 diabetes received enhanced treatment as usual (ETAU), including medication adherence, self-monitoring of blood glucose (SMBG), and lifestyle counseling; a provider letter documented psychiatric diagnoses.

Pathways to quality inpatient management of hyperglycemia and diabetes: a call to action.

Currently patients with diabetes comprise up to 25-30% of the census of adult wards and critical care units in our hospitals. Although evidence suggests that avoidance of hyperglycemia (>180 mg/dL) and hypoglycemia (<70 mg/dL) is beneficial for positive outcomes in the hospitalized patient, much of this evidence remains controversial and at times somewhat contradictory. We have recently formed a consortium for Planning Research in Inpatient Diabetes (PRIDE) with the goal of promoting clinical research in the area of management of hyperglycemia and diabetes in the hospital.

Validity of medication adherence self-reports in adults with type 2 diabetes.

Objective: To assess the validity of self-report measures of diabetes medication adherence and evaluate the effect of depression on the validity of these reports.

Research Design And Methods: Adults with type 2 diabetes, treated with oral medications, completed a set of medication adherence self-reports that varied response scales and time frames, were administered structured clinical interviews for depression, and provided blood samples for HbA(1c) as part of a screening for an intervention study. A subsample of participants with HbA(1c) ≥7.

Impact of inpatient diabetes management, education, and improved discharge transition on glycemic control 12 months after discharge.

Aim: To determine whether inpatient diabetes management and education with improved transition to outpatient care (IDMET) improves glycemic control after hospital discharge in patients with uncontrolled type 2 diabetes (T2DM).

Methods: Adult inpatients with T2DM and HbA1c > 7.5% (58 mmol/mol) admitted for reasons other than diabetes to an academic medical center were randomly assigned to either IDMET or usual care (UC).

Improvement in outcomes of clinical islet transplantation: 1999-2010.

Objective: To describe trends of primary efficacy and safety outcomes of islet transplantation in type 1 diabetes recipients with severe hypoglycemia from the Collaborative Islet Transplant Registry (CITR) from 1999 to 2010.

Research Design And Methods: A total of 677 islet transplant-alone or islet-after-kidney recipients with type 1 diabetes in the CITR were analyzed for five primary efficacy outcomes and overall safety to identify any differences by early (1999-2002), mid (2003-2006), or recent (2007-2010) transplant era based on annual follow-up to 5 years.

Results: Insulin independence at 3 years after transplant improved from 27% in the early era (1999-2002, n = 214) to 37% in the mid (2003-2006, n = 255) and to 44% in the most recent era (2007-2010, n = 208; P = 0.

Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in Type 2 Diabetes.

Depression is one of the most common psychological problems among individuals diabetes, and it is associated with worse treatment adherence and clinical outcomes. As part of a program of treatment research aimed at integrating interventions for depression and treatment nonadherence, five depressed patients with suboptimally controlled type 2 diabetes were treated with 10-12 sessions of individual cognitive behavioral therapy for adherence and depression (CBT-AD) in a case-series design. The intervention was delivered in a hospital setting by a collaborative team consisting of a psychologist, a nurse educator, and a dietitian.

Effectiveness of a computerized insulin order template in general medical inpatients with type 2 diabetes: a cluster randomized trial.

Objective: To determine whether an electronic order template for basal-bolus insulin ordering improves mean blood glucose in hospitalized general medical patients with hyperglycemia and type 2 diabetes.

Research Design And Methods: We randomly assigned internal medicine resident teams on acute general medical floors to the use of an electronic insulin order template or usual insulin ordering. We measured diabetes care parameters for 1 month on all patients with type 2 diabetes and blood glucose <60 mg/dl or >180 mg/dl treated by these physicians.

Predictive factors for in-stent late loss and coronary lesion progression in patients with type 2 diabetes mellitus randomized to rosiglitazone or placebo.

Background: Type 2 diabetics (DM2) are at increased risk for restenosis as well as nonculprit coronary artery lesion (NCCL) progression. Rosiglitazone (RSG) favorably modifies many of the altered biologic processes in DM2, although recent reports have questioned its safety. We conducted a double-blind randomized trial to assess the effects of RSG versus placebo on in-stent late lumen loss (LL) and angiographic progression of NCCL.

Symptoms of depression prospectively predict poorer self-care in patients with Type 2 diabetes.

Aims: To examine prospectively the association of depression symptoms with subsequent self-care and medication adherence in patients with Type 2 diabetes mellitus.

Methods: Two hundred and eight primary care patients with Type 2 diabetes completed the Harvard Department of Psychiatry/National Depression Screening Day Scale (HANDS) and the Summary of Diabetes Self-Care Activities (SDSCA) at baseline and at follow-up, an average of 9 months later. They also self-reported medication adherence at baseline and at a follow-up.

Point-of-care glucose and hemoglobin A1c in emergency department patients without known diabetes: implications for opportunistic screening.

Objectives: The objectives were to evaluate the correlation between random glucose and hemoglobin A1c (HbA1c) in emergency department (ED) patients without known diabetes and to determine the ability of diabetes screening in the ED to predict outpatient diabetes.

Methods: This was a cross-sectional study at an urban academic ED. The authors enrolled consecutive adult patients without known diabetes during eight 24-hour periods.

Prevalence of elevated hemoglobin A1c among patients admitted to the hospital without a diagnosis of diabetes.

Context: One in four hospitalized patients has diagnosed diabetes. The prevalence of unrecognized, or undiagnosed, diabetes among hospitalized patients is not well established.

Objective: Our objective was to determine the prevalence of unrecognized probable diabetes in this patient population determined by elevated hemoglobin A1c (HbA1c) level.

Pathology of an islet transplant 2 years after transplantation: evidence for a nonimmunological loss.

Background: We report the immunological and pathological findings of a 52-year-old woman, who died two years after the second of two islet transplants performed using the Edmonton protocol. After each islet transplant, she gradually lost insulin independence while maintaining low levels of C-peptide secretion.

Methods: A complete autopsy was performed including pathological and immunohistochemical analysis of hepatic allogeneic islets and native pancreatic islets to identify rejection or autoimmunity.

Value of risk stratification to increase the predictive validity of HbA1c in screening for undiagnosed diabetes in the US population.

Background: Opportunistic screening using hemoglobin A1c (HbA1c) may improve detection of undiagnosed diabetes but remains controversial.

Objective: To evaluate the predictive validity of HbA1c as a screening test for undiagnosed diabetes in a risk-stratified sample of the US population.

Design: Weighted cross-sectional analysis of diabetes risk factors, HbA1c, and fasting plasma glucose (FPG) in National Health and Nutrition Examination Survey (NHANES), 1999-2004.

Measuring psychological insulin resistance: barriers to insulin use.

Purpose: The purpose of this study is to explore the attitudes that contribute to psychological insulin resistance (PIR) in insulin-naive patients with type 2 diabetes and to identify predictors of PIR.

Methods: A prospective study using 2 self-report surveys and incorporating demographic and health variables was conducted to determine the prevalence of PIR among a sample of 100 adult, insulin-naive patients with type 2 diabetes at an outpatient diabetes center in a university-affiliated teaching hospital.

Results: Thirty-three percent of patients with type 2 diabetes were unwilling to take insulin.

Inpatient diabetes management in non-ICU settings: evidence and strategies.

The epidemic of diabetes and results from several recent trials demonstrating the benefits of intensive glycemic control in the ICU setting have focused attention on inpatient glycemic control on general hospital wards, where over 25% of patients have diabetes. Current management of inpatient glycemia is haphazard, relying on corrective doses of insulin after hyperglycemia has occurred (the insulin "sliding scale"). Although data to guide evidence-based management of inpatient glycemia in non-critically ill patients are scant, the American College of Endocrinology and the American Diabetes Association have advocated more intensive therapy in the general inpatient setting, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has followed suit, launching an initiative on inpatient glycemic control.

Retinal haemodynamics in individuals with well-controlled type 1 diabetes.

Aims/hypothesis: Abnormalities in retinal haemodynamics have been reported in patients with type 1 diabetes in advance of clinical retinopathy. These abnormalities could therefore be useful as early markers or surrogate endpoints for studying the microangiopathy. Since the DCCT, the increased focus on good glycaemic control is changing the natural history of diabetic retinopathy.