Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.

Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research

Are patients with type 2 diabetes reluctant to start insulin therapy? An examination of the scope and underpinnings of psychological insulin resistance in a large, international population

To examine the scope and underpinnings of psychological insulin resistance (PIR) across eight Western nations, with special attention to the potential influence of beliefs about insulin and broader patient beliefs regarding medications and diabetes. A total of 1400 subjects with insulin-naïve, type 2 diabetes across eight nations completed an online survey. The survey assessed willingness to start insulin, beliefs about insulin and current medications, and diabetes-related emotional distress. The majority of respondents were male (59.3%), mean age was 51.6 years and mean diabetes duration was 6.1 years. A total of 17.2% reported they would be unwilling to start insulin (the PIR group), while 34.7% were ambivalent and 48.1% indicated they would be willing to do so. Marked differences by country were apparent, with PIR ranging from 5.9% (Spain) to 37.3% (Italy). Both unwilling and ambivalent patients reported significantly more negative (p  < 0.001; p  < 0.05) and fewer positive beliefs (p  < 0.001; p  < 0.01) about starting insulin, more negative feelings about their current medications (p  < 0.01, p  < 0.001), and more diabetes-related distress (p  < 0.001; p  < 0.05) than willing patients. Unwilling patients also reported significantly more negative (p  < 0.05) and fewer positive beliefs (p  < 0.001) about starting insulin than ambivalent patients. These are the first data demonstrating the prevalence of PIR across Western nations. PIR is strongly linked to positive and negative insulin beliefs, and may also reflect a broader discomfort with medications and with diabetes in general. Of note, however, PIR is a marker of behavioral intent only; it is not known whether this predicts actual behavior at the time when insulin is prescribed. When addressing patients who are reluctant to initiate insulin therapy, clinicians may find it valuable to inquire about their beliefs about insulin and their current medication

Diabetes-related emotional distress in Dutch and U.S. diabetic patients: Cross-cultural validity of the problem areas in diabetes scale

To examine the cross-cultural validity of the Problem Areas in Diabetes Scale (PAID) in Dutch and U.S. diabetic patients. A total of 1,472 Dutch people with diabetes completed the PAID along with other self-report measures of affect. Statistics covered Cronbach's alpha, exploratory factor analysis (EFA), and confirmatory factor analysis (CFA), Pearson's product-moment correlation, and t tests. Psychometric properties of PAID were compared for Dutch and U.S. diabetic patients. Internal consistency of the Dutch PAID was high and stable across sex and type of diabetes. Test-retest reliability was high. Principal component analyses confirmed 1 general 20-item factor, whereas EFA identified 4 new subdimensions: negative emotions, treatment problems, food-related problems, and lack of social support. These dimensions were confirmed with CFA and were replicated in the U.S. sample. The PAID and its subscales demonstrated moderate to high associations in the expected direction with other measures of affect. Dutch and U.S. subjects reported having the same problem areas, with U.S. patients reporting higher emotional distress levels both in type 1 and type 2 diabetes. The Dutch and U.S. 20-item PAID appeared to be psychometrically equivalent, which allowed for cross-cultural comparison

Do physicians understand type 2 diabetes patients' perceptions of seriousness; the emotional impact and needs for care improvement? A cross-national survey

Objective: To explore across countries the extent to which physicians understand Type 2 diabetes patients' perceptions of seriousness, worries about complications, emotional distress, and needs for care improvement. Methods: Cross-sectional data were collected in a multinational survey (SHARED). Type 2 diabetes patients (n= 1609), general practitioners (n= 818) and diabetes specialists (n= 697) from eight countries were included. Data were gathered online and via telephone interviews. Responses from patients and professionals were compared using descriptive statistics and multilevel analyses. Results: Patients generally perceived diabetes as a serious condition and reported moderate distress. Physicians tended to underestimate patients' perceived seriousness, while overestimating their level of distress. Physicians had difficulty estimating which diabetes complications concerned patients most, and what they needed to feel more confident about their diabetes. Patients did not wish for more consultation time, but rather active involvement, information and easy access to their physician. Conclusion: Results of this large survey highlight the importance of patient involvement and shared decision making. Practice implications: Further improvement of patient-provider communication as a basis for shared responsibilities and achieving optimal treatment outcomes is needed. With the growing numbers of diabetes patients worldwide, task delegation should be considered, in the framework of a multidisciplinary diabetes care model. © 2010 Elsevier Ireland Ltd

Towards defining a cut-off score for elevated fear of hypoglycemia on the Hypoglycemia Fear Survey Worry subscale in patients with type 2 diabetes

Objective To determine a cutoff score for clinically meaningful fear of hypoglycemia (FoH) on the Hypoglycemia Fear Survey Worry subscale (HFS-W). Research design and methods Data on the HFS-W, history of hypoglycemia, emotional well-being (World Health Organization-5 well-being index), and distress about diabetes symptoms (Diabetes Symptom Checklist–Revised) were available from Dutch patients with type 2 diabetes who were treated with oral medication or insulin (n = 1,530). Four criteria were applied to define a threshold for clinically meaningful FoH: 1) modal score distribution (MD criterion), 2) scores 2 SDs above the mean (SD criterion), 3) concurrent validity with severe hypoglycemia and suboptimal well-being (CV criterion), and 4) an elevated score (≥3) on more than one HFS-W item (elevated item endorsement [EI criterion]). Associations between the outcomes of these approaches and a history of severe hypoglycemia and suboptimal well-being were studied. Results Of the 1,530 patients, 19% had a HFS-W score of 0 (MD criterion), and 5% reported elevated FoH (HFS-W ≥ mean + 2 SD; SD criterion). Patients with severe hypoglycemia reported higher HFS-W scores than those without (25 ± 20 vs. 15 ± 17; P < 0.001). Patients with suboptimal well-being reported higher HFS-W scores than those with satisfactory well-being (20 ± 18 vs. 13 ± 15; P < 0.001, CV criterion). Elevated FoH (defined by the EI criterion) was seen in 26% of patients. The SD and EI criteria were the strongest associated with history of severe hypoglycemia. The EI criterion was the strongest associated with suboptimal well-being. Conclusions Although no definite cutoff score has been determined, the EI criterion may be most indicative of clinically relevant FoH in this exploratory study. Further testing of the clinical relevance of this criterion is needed

Type 2 Diabetes: Model of Factors Associated with Glycemic Control

Objectives The purpose of this study was to evaluate the related factors and their intercorrelated impacts on glycemic control in people with type 2 diabetes mellitus. Methods Patients with type 2 diabetes were recruited for this study during their regular clinic visits at a major medical centre in Iran. Glycated hemoglobin (A1C) levels were used as the indicator of glycemic control. Regression analysis was used to determine the relationships between glycemic control and demographics, self-care behaviours, resources and affective variables. Moreover, the associations between diabetes-related distress and measured variables were tested. Results Three hundred eighty people with type 2 diabetes completed the study. The mean duration of diabetes was 8.94±6.57 years, and the mean A1C levels were 7.78±1.7. Diabetes-related distress was significantly associated with A1C levels, controlling for all other variables (p=0.01). On the other hand, depression (p<0.001), self-management (p<0.001), anxiety (p<0.001) and patient-physician relationship (p=0.023) were significantly associated with diabetes-related distress. Conclusions Diabetes-related distress was found to be associated with glycemic control in people with type 2 diabetes, whereas age, depression, anxiety, self-management and family and social support may affect glycemic control indirectly through diabetes-related distress. Thus, it is important to assess and, if appropriate, treat people with diabetes for diabetes-related distress in order to identify and help them overcome barriers to optimal glycemic control. © 2016 Canadian Diabetes Associatio

Clinical Utility of SMBG: Recommendations on the Use and Reporting of SMBG in Clinical Research

Roche Diagnostics Germany GmbH; Roche DiagnosticsSCI(E)[email protected]