Changes in weight control behaviors and hedonic hunger in a commercial weight management program adapted for individuals with type 2 diabetes.

BACKGROUND: A WW (formerly Weight Watchers) program adapted for persons with type 2 diabetes mellitus (T2DM) previously was found to be more effective than standard care (SC) intervention for weight loss, improved glycemic control, and weight- and diabetes-related quality of life measures. With data from the same national trial, this study examined whether WW adapted for persons with T2DM also increased engagement in weight control behaviors and decreased hedonic hunger, each of which could contribute to improved diabetes management. INTERVENTION AND METHODS: Individuals with T2DM (n = 563) and overweight or obesity participated in a 12-month, 16-site, randomized trial of WW with diabetes counseling or SC. Hierarchical linear modeling (HLM) evaluated whether 12-month changes in weight control behaviors (Eating Behavior Inventory; EBI) and hedonic hunger (Power of Food Scale; PFS) differed by treatment condition. If a significant treatment effect was found, 12-month changes in EBI/PFS were regressed on 12-month changes in HbA1c and percent weight loss to explore potential treatment differences in these associations. RESULTS: EBI scores increased significantly over the 12-months (p < 0.001), with greater improvements in WW than SC (p < 0.001). PFS decreased significantly in the 12-months (p < 0.001), with no differences between treatment groups (p = 0.15). HLM analyses that followed up on the significant treatment effect for 12-month change in EBI revealed no significant differences by treatment condition for the relationship between change in EBI scores and change in HbA1c (p = 0.14) or percent weight loss (p = 0.32). Across all participants, 12-month improvements in EBI and PFS were related to improved HbA1c (r = 0.22; -0.13, respectively) and greater percent weight loss (r = 0.41; -0.18, respectively) (ps < 0.01). CONCLUSIONS: WW with diabetes counseling produced greater engagement in weight control behaviors in those with T2DM than did SC. Across both groups, improved weight control behaviors and hedonic hunger were related to improved glycemic control and weight loss.

Challenges of inpatient blood glucose monitoring: standards, methods, and devices to measure blood glucose.

Glucose control in the hospital setting is very important. There is a high incidence of hyperglycemia, hypoglycemia, and glycemic variability in hospitalized patients. Safe insulin delivery and glucose control is dependent on reliable glucose meters and monitoring systems in the hospital. Different glucose monitoring systems use arterial, venous, central venous, and capillary blood samples. It is important for clinicians to be aware that there are limitations of specific point-of-care (POC) glucose meters and that situations exist whereby POC glucose meters as the sole measurement device should be avoided. POC meter devices are not approved by the Food and Drug Administration for use in critical care, although POC meter devices are commonly used in critical care settings and elsewhere. This review focuses on glucose assay principles, instrument technology, influences on glucose measurement, standards for glucose measurement, and an evaluation of different methods to measure blood glucose in the hospital setting.

Evaluation of Ward Management of Diabetic Ketoacidosis.

Ward management of diabetic ketoacidosis (DKA) using subcutaneous insulin in specific patient populations is safe and effective, but insulin administered by continuous infusion has not been analyzed in this setting. This retrospective cohort study utilizing a nursing-driven, continuous infusion insulin calculator demonstrated safe and effective treatment of patients with DKA on medicine wards.

Continuous Glucose Monitoring: Review of an Innovation in Diabetes Management.

Most continuous glucose monitors (CGM) provide interstitial fluid glucose trends, which reflect blood glucose trends with alarms and alerts to prevent hypoglycemia and provide better glycemic control. CGM used in conjunction with insulin pumps has changed the management of patients with insulin-dependent diabetes, mainly type 1 diabetes. CGM technology prevents the need for frequent blood glucose testing, which is often cumbersome for patients, providing them with a better alternative. CGM technology is underprescribed and therefore advantage should be taken of this technology to provide better hemoglobin A1c (HbA1c) control and decrease incidence of diabetic complications. CGM is particularly useful in patients with hypoglycemia unawareness and nocturnal hypoglycemia. CGM is currently not approved in pregnant patients, in critically ill patients and patients on dialysis. Research suggests that the benefits certainly outweigh the limitations of this technology. This review article focuses on the technical and clinical use of continuous glucose monitoring and sensor-integrated pump technology.

Outcomes of a cardiothoracic intensive care web-based online intravenous insulin infusion calculator study at a Medical University Hospital.

BACKGROUND: The purpose of this study was to examine whether a web-based, on-line intravenous insulin (IVI) infusion calculator (IVIIC) program for the delivery of IVI therapy in coronary artery bypass graft (CABG) patients was superior to a prior IVI protocol used in the cardiothoracic intensive care unit at our institution. METHODS: The study included 97 CABG patients studied from October 2004 to February 2005 pre-protocol (type 2 diabetes) and October 2005 to February 2006 post-protocol (with or without type 2 diabetes). The IVIIC was programmed to resemble an algorithm whereby any patient with type 2 diabetes or a blood glucose (BG) greater than 120 mg/dL was started on IVI with an insulin sensitivity factor, a multiplier of 0.03. The calculator used the following mathematical formula: rate of insulin infusion/hour = (current BG - 60 mg/dL) x 0.03. RESULTS: Pre- and post-protocol groups for patients with type 2 diabetes were similar in all demographics measured, including initial age, mean age, percentage female, and percentage African-American. Significant differences were observed between pre- and post-protocol groups in mean BG recorded over a 48-h period (P < 0.0001), percentage not at target within 48 h (P < 0.0001), mean hours to first BG between 80 to 120 mg/dL (P < 0.0001), mean hours to target (three consecutive BGs 80-120 mg/dL) (P < 0.0001), and hyperglycemic index (P < 0.0001). The incidence of hypoglycemia (percentage BG < 70 mg/dL) was not significantly increased in the post-protocol groups (P = 0.2581). CONCLUSIONS: We conclude that the IVIIC is a safe nurse-driven protocol with excellent BG outcomes.

Current concepts in targeted therapies for the pathophysiology of diabetic microvascular complications.

Microvascular complications characterized by retinopathy, nephropathy, and neuropathy are highly prevalent among diabetics. Glycemic control has long been the mainstay for preventing progression of these complications; however, such control is not easily achieved. Currently, alternative adjunctive approaches to treating and preventing microvascular damage are being undertaken by targeting the molecular pathogenesis of diabetic complications. This review summarizes the specific pathogenic mechanisms of microvascular complications for which clinical therapies have been developed, including the polyol pathway, advanced glycation end products, protein kinase c, vascular epithelium growth factor, and the superoxide pathway. The review further focuses on therapies for these targets that are currently available or are undergoing late-stage clinical trials.

Relationship between risk factor control and vascular events in the SAMMPRIS trial.

OBJECTIVE: The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study is the first stroke prevention trial to include protocol-driven intensive management of multiple risk factors. In this prespecified analysis, we aimed to investigate the relationship between risk factor control during follow-up and outcome of patients in the medical arm of SAMMPRIS. METHODS: Data from SAMMPRIS participants in the medical arm (n = 227) were analyzed. Risk factors were recorded at baseline, 30 days, 4 months, and then every 4 months for a mean follow-up of 32 months. For each patient, values for all risk factor measures were averaged and dichotomized as in or out of target. RESULTS: Participants who were out of target for systolic blood pressure and physical activity, as well as those with higher mean low-density lipoprotein cholesterol and non-high-density lipoprotein, were more likely to have a recurrent vascular event (stroke, myocardial infarction, or vascular death) at 3 years compared to those who had good risk factor control. In the multivariable analysis, greater physical activity decreased the likelihood of a recurrent stroke, myocardial infarction, or vascular death (odds ratio 0.6, confidence interval 0.4-0.8). CONCLUSIONS: Raised blood pressure, cholesterol, and physical inactivity should be aggressively treated in patients with intracranial atherosclerosis to prevent future vascular events. Physical activity, which has not received attention in stroke prevention trials, was the strongest predictor of a good outcome in the medical arm in SAMMPRIS. CLINICALTRIALSGOV IDENTIFIER: NCT00576693.

Impact on psychosocial outcomes of a nationally available weight management program tailored for individuals with type 2 diabetes: Results of a randomized controlled trial.

AIMS: Type 2 diabetes mellitus (T2DM) can substantially decrease quality of life (QOL). This study examined the effects on QOL-relevant psychosocial measures of a widely available commercial weight loss program enhanced for individuals with T2DM. METHODS: A year-long multi-site randomized clinical trial compared the Weight Watchers (WW) approach, supplemented with phone and email counseling with a certified diabetes educator (CDE), to brief standard diabetes nutrition counseling and education (Standard Care; SC). Participants were 400 women and 163 men (N=279 WW; 284 SC) with T2DM [mean (±SD) HbA1c 8.32±1%; BMI=37.1±5.7kg/m2; age=55.1 ± 9.1years]. Psychosocial outcomes were assessed at baseline, month 6, and month 12 using a diabetes specific psychosocial measure (Diabetes Distress Scale [DDS]), Impact of Weight on Quality of Life-Lite scale (IWQOL), a generic QOL measure (SF-36), and a depression screen (PHQ-9). RESULTS: WW participants showed significantly greater improvements than did SC participants on all DDS subscales and total score and on IWQOL total score and physical function, sex life and work domains (all ps<.05). There was no significant treatment effect on SF-36 scores or PHQ-9. CONCLUSIONS: WW enhanced for individuals with T2DM was superior to SC in improving psychosocial outcomes most specific to T2DM and obesity. Available commercial WL programs, combined with scalable complementary program-specific diabetes counseling, may have benefits that extend to diabetes-related distress and weight-relevant QOL.

The Diabetes Initiative of South Carolina Celebrates Over 20 Years of Professional Diabetes Education.

BACKGROUND: Diabetes is a major public health problem in South Carolina; however, the Diabetes Initiative of South Carolina (DSC) provides a realistic mechanism to address issues on a statewide basis. METHODS: The Diabetes Center of Excellence in the DSC provides oversight for developing and supervising professional education programs for health care workers of all types in South Carolina to increase their knowledge and ability to care for people with diabetes. The DSC has developed many programs for the education of a variety of health professionals about diabetes and its complications. RESULTS: The DSC has sponsored 21 Annual Diabetes Fall Symposia for primary health care professionals featuring education regarding many aspects of diabetes mellitus. The intent of the program is to enhance the lifelong learning process of physicians, advanced practice providers, nurses, pharmacists, dietitians, laboratorians and other health care professionals, by providing educational opportunities and to advance the quality and safety of patient care. The symposium is an annual 2-day statewide program that supplies both a comprehensive diabetes management update to all primary care professionals and an opportunity for attendees to obtain continuing education credits at a low cost. CONCLUSION: The overarching goal of the DSC is that the programs it sponsors and the development of new targeted initiatives will lead to continuous improvements in the care of people at risk and with diabetes along with a decrease in morbidity, mortality and costs of diabetes and its complications in South Carolina and elsewhere.

Newer oral and noninsulin therapies to treat type 2 diabetes mellitus.

The pathophysiology of type 2 diabetes mellitus involves several biologic mechanisms and no single medication addresses them all. Most patients require more than one medication to adequately treat their diabetes, needing drugs with unique and complementary mechanisms of action to address and balance insulin and glucagon levels. In the past decade, several therapeutic drug classes have been developed for type 2 diabetes mellitus. Each provides therapeutic options with novel mechanisms of action to help clinicians achieve the goal of glucose homeostasis while controlling adverse events, especially reducing the risk of hypoglycemia.

Hospital Guidelines for Diabetes Management and the Joint Commission-American Diabetes Association Inpatient Diabetes Certification.

BACKGROUND: The Joint Commission Advanced Inpatient Diabetes Certification Program is founded on the American Diabetes Association's Clinical Practice Recommendations and is linked to the Joint Commission Standards. Diabetes currently affects 29.1 million people in the USA and another 86 million Americans are estimated to have pre-diabetes. On a daily basis at the Medical University of South Carolina (MUSC) Medical Center, there are approximately 130-150 inpatients with a diagnosis of diabetes. METHODS: The program encompasses all service lines at MUSC. Some important features of the program include: a program champion or champion team, written blood glucose monitoring protocols, staff education in diabetes management, medical record identification of diabetes, a plan coordinating insulin and meal delivery, plans for treatment of hypoglycemia and hyperglycemia, data collection for incidence of hypoglycemia, and patient education on self-management of diabetes. RESULTS: The major clinical components to develop, implement, and evaluate an inpatient diabetes care program are: I. Program management, II. Delivering or facilitating clinical care, III. Supporting self-management, IV. Clinical information management and V. performance measurement. The standards receive guidance from a Disease-Specific Care Certification Advisory Committee, and the Standards and Survey Procedures Committee of the Joint Commission Board of Commissioners. CONCLUSIONS: The Joint Commission-ADA Advanced Inpatient Diabetes Certification represents a clinical program of excellence, improved processes of care, means to enhance contract negotiations with providers, ability to create an environment of teamwork, and heightened communication within the organization.

Randomized controlled trial of a nationally available weight control program tailored for adults with type 2 diabetes.

OBJECTIVE: Modest weight loss from clinical interventions improves glycemic control in type 2 diabetes (T2DM). Data are sparse on the effects of weight loss via commercial weight loss programs. This study examined the effects on glycemic control and weight loss of the standard Weight Watchers program, combined with telephone and email consultations with a certified diabetes educator (WW), compared with standard diabetes nutrition counseling and education (standard care, SC). METHODS: In a 12-month randomized controlled trial at 16 U.S. research centers, 563 adults with T2DM (HbA1c 7-11%; BMI 27-50 kg/m2 ) were assigned to either the commercially available WW program (regular community meetings, online tools), plus telephone and email counseling from a certified diabetes educator, or to SC (initial in-person diabetes nutrition counseling/education, with follow-up informational materials). RESULTS: Follow-up rate was 86%. Twelve-month HbA1c changes for WW and SC were -0.32 and +0.16, respectively; 24% of WW versus 14% of SC achieved HbA1c <7.0% (P = 0.004). Weight losses were -4.0% for WW and -1.9% for SC (Ps < 0.001). 26% of WW versus 12% of SC reduced diabetes medications (P < 0.001). WW participants had greater reductions in waist circumference (P < 0.001) and C-reactive protein (P = 0.02) but did not differ on other cardiovascular risk factors. CONCLUSIONS: Widely available commercial weight loss programs with community and online components, combined with scalable complementary diabetes education, may represent accessible and effective components of management plans for adults with overweight/obesity and T2DM.

In vivo glycated low-density lipoprotein is not more susceptible to oxidation than nonglycated low-density lipoprotein in type 1 diabetes.

It has been suggested that low-density lipoprotein (LDL) modified by glycation may be more susceptible to oxidation and thus, enhance its atherogenicity. Using affinity chromatography, LDL glycated in vivo (G-LDL) and relatively nonglycated. (N-LDL) subfractions can be isolated from the same individual. The extent of and susceptibility to oxidation of N-LDL compared with G-LDL was determined in 15 type 1 diabetic patients. Total LDL was isolated and separated by boronate affinity chromatography into relatively glycated (G-) and nonglycated (N-) subfractions. The extent of glycation, glycoxidation, and lipoxidation, lipid soluble antioxidant content, susceptibility to in vitro oxidation, and nuclear magnetic resonance (NMR)-determined particle size and subclass distribution were determined for each subfraction. Glycation, (fructose-lysine) was higher in G-LDL versus N-LDL, (0.28 +/- 0.08 v 0.13 +/- 0.04 mmol/mol lysine, P < .0001). However, levels of glycoxidation/lipoxidation products and of antioxidants were similar or lower in G-LDL compared with N-LDL and were inversely correlated with fructose-lysine (FL) concentrations in G-LDL, but positively correlated in N-LDL. In vitro LDL (CuCl2) oxidation demonstrated a longer lag time for oxidation of G-LDL than N-LDL (50 +/- 0.16 v 37 +/- 0.15 min, P < .01), but there was no difference in the rate or extent of lipid oxidation, nor in any aspect of protein oxidation. Mean LDL particle size and subclass distribution did not differ between G-LDL and N-LDL. Thus, G-LDL from well-controlled type 1 diabetic patients is not more modified by oxidation, more susceptible to oxidation, or smaller than relatively N-LDL, suggesting alternative factors may contribute to the atherogenicity of LDL from type 1 diabetic patients.

Inflammatory biomarkers, glycemic variability, hypoglycemia, and renal transplant outcomes: results of a randomized controlled trial.

BACKGROUND: We previously reported that compared to standard glycemic control [blood glucose (BG): 70-180 mg/dL], patients randomized to intensive glycemic control (BG: 70-110 mg/dL) were at increased risk of graft rejection in renal transplantation. However, the underlying mechanisms that associate the effect of intensive glycemic control with renal transplant outcomes have not been identified. METHODS: A secondary data analysis of 93 participants (n=44 intensive, n=49 control) was conducted using data from a previous randomized controlled clinical trial. We examined inflammatory biomarkers, glycemic variability, hypoglycemia, and hyperglycemia as potential contributing etiologies by assessing the effect of intensive glycemic control on these characteristics, and evaluate the association of these variables with graft rejection. RESULTS: Intensive glycemic control had no appreciable effect on highly sensitive C-reactive protein, interleukin (IL)-6, tumor necrosis factor alpha, IL-1ß, or IL-10 levels at all time points after transplantation. Moreover, neither inflammatory biomarkers nor increased glycemic variability were associated with graft rejection. However, intensive treatment increased the risk of hypoglycemia (BG <70 mg/dL, 84% vs. 25%, P<0.001). In sub-analysis, compared to non-rejecters, rejecters demonstrated higher rates of blood glucose below 70 mg/dL (90% vs. 49%, P=0.02). CONCLUSION: Inflammatory biomarkers and increased glycemic variability lack correlation with clinical outcomes in renal transplant, but importantly, increased perioperative hypoglycemic episodes (BG <70mg/dL) may be a salient etiology that contributed to the increased risk for acute allograft rejection related to intensive glycemic control. Further research is needed to confirm a causal association.

The diabetes initiative of South Carolina and the 18th Annual Diabetes Fall Symposium for Health Care Professionals.

The Diabetes Initiative of South Carolina (DSC) is charged with the development of guidelines for the management of diabetes and supporting adherence to evidence-based standards for education and care. The DSC is committed to lowering the burden of diabetes in the state through translation of evidence-based standards of clinical practice, and patient and community education centered on blood glucose control, blood pressure control, healthy eating, physical activity, and foot care. The DSC has developed many programs for the education of a variety of health professionals about diabetes and its complications. DSC has sponsored 18 Annual Diabetes Fall Symposia for primary health care professionals featuring education on all aspects of diabetes mellitus. The intent of the program is to enhance the lifelong learning process of physicians, nurses, pharmacists, dietitians and other health care professionals by providing educational opportunities and to advance the quality and safety of patient care.

Glucocorticoid-induced hyperglycemia.

OBJECTIVES: Provide treatment guidelines for glucocorticoid-induced hyperglycemia and to understand the clinical implications of glucocorticoid-induced hyperglycemia. METHODS: The authors analyzed an electronic search (Medline) and a literature review of the pertinent articles published from 1980 to September 2012. RESULTS: In patients treated with glucocorticoids, the odds ratio for development of new-onset diabetes mellitus has been reported to be 1.36 to 2.31. The prevalence of abnormal glucose metabolism in post renal transplant patients taking glucocorticoids has been reported to be 17% to 32%. Sustained glucocorticoid treatment increases the potential for future cardiovascular disease through multiple pathways, resulting in a trade-off between benefit and harm. Complications related to glucocorticoid treatments are associated with the total glucocorticoid dose and duration of therapy. Other risk factors include age and body mass index. Understanding the pharmacodynamics and clinical implications of glucocorticoid-induced hyperglycemia can promote recognition and improvement of its treatment. CONCLUSIONS: Glucocorticoid-induced hyperglycemia has significant clinical implications in patients with diabetes mellitus and without diabetes mellitus. Early recognition and proper proactive management of glucocorticoid-induced hyperglycemia should enhance care for patients receiving glucocorticoid treatment. Furthermore, treatment has been effective for both the inpatient and the outpatient settings.

South Carolina guidelines for diabetes care 2013.

BACKGROUND: There is a huge economic burden of diabetes in South Carolina. METHODS: The South Carolina Guidelines for Diabetes Care were based on the 2013 Standards of Medical Care from the American Diabetes Association. RESULTS: From a review of the Diabetes Quality Indicators in South Carolina 2007, Medicare claims data show: 65% of South Carolinians with diabetes insured by Medicare received 2 A1C test per year, 54% received an eye examination and 78% received a lipid panel. Only 42% of these individuals with diabetes had all 3 tests in the same year. In addition, only 50% of individuals with diabetes in South Carolina attended a diabetes self-management class. To improve the statistics and outcomes, the Diabetes Advisory Council provided the evidence-based South Carolina Guidelines for Diabetes Care. They are based on the 2013 Standards of Medical Care from the American Diabetes Association. These guidelines have been promoted at the continuing education programs sponsored by the Diabetes Initiative of South Carolina and the South Carolina Division of Diabetes Prevention and Control and distributed in the community sites by the Racial and Ethnic Approaches to Community Health coalition. CONCLUSIONS: The South Carolina Guidelines for Diabetes will provide evidence-based therapy and monitoring to minimize complications from diabetes and promote a higher quality of life for those with diabetes.

A randomized controlled trial to evaluate the effect of glycemic control on renal transplantation outcomes.

CONTEXT: Outcomes from intensive glycemic control postrenal transplant have not been studied. OBJECTIVE: Our objective was to observe the optimal management of hyperglycemia in patients with diabetes or impaired glucose tolerance receiving renal transplantation. DESIGN, SETTING, AND PATIENTS: We conducted a randomized controlled trial with patients undergoing renal transplantation randomized to either i.v. insulin therapy (intensive) or standard s.c. insulin therapy while the patients were admitted to the hospital. INTERVENTIONS: The study consisted of a 3-day postrenal transplant group treated with intensive i.v. insulin [blood glucose (BG) = 70-110 mg/dl] or a control group treated with s.c. insulin (BG = 70-180 mg/dl). MAIN OUTCOME MEASURE: The primary endpoint was delayed graft function (DGF). Secondary endpoints were glycemic control, graft survival, and acute rejection episodes. RESULTS: A total of 104 patients were screened and randomized to either the intensive or control condition; however, the intention-to-treat analysis set consisted of only the 93 participants (n = 44 intensive, n = 49 control) that underwent a renal transplant. DGF was present in 18% (eight of 44) of the intensive group and 24% (12 of 49) of the control group (P = 0.46). The occurrence of severe hypoglycemia (BG < 40 mg/dl) and severe hyperglycemia (BG > 350 mg/dl) were the primary safety outcome measures. There were nine participants with hypoglycemia identified, seven of which (78%) were in the intensive treatment group (P = 0.08). There were 30 instances of hyperglycemia with five participants (11%) in the intensive group and 12 participants (24%) in the control group having at least one hyperglycemic event (P = 0.10). For the 11 rejection episodes, nine were in the intensive treatment group (P = 0.013). CONCLUSIONS: The primary outcome measure of DGF was not statistically different for the two treatment groups. Regarding longer-term rejection and graft survival, the intensively treated participants were at higher risk for a rejection episode.

Relative risk estimated from the ratio of two median unbiased estimates.

Clinical trials often include binary endpoints. In some cases, no successes are observed and the usual large-sample estimates of relative risk are undefined. This paper proposes an estimator for relative risk based on the median unbiased estimator. The proposed relative risk estimator is well defined and performs satisfactorily for a wide range of data configurations. To facilitate the use of the estimator, a deterministic bootstrap confidence interval is also proposed, and a SAS MACRO is available to perform the necessary calculations. An ongoing randomized clinical trial motivated the development of the estimator and is used to illustrate the approach.