Assessing Barriers and Adherence to Insulin Injection Technique in People With Diabetes: Development and Validation of New Assessment Tools.

BACKGROUND: The correct injection technique is crucial for people with insulin therapy. However, barriers to insulin injections exist, which can lead to problems with injections. In addition, injection behavior may deviate from recommendations leading to lower adherence to the correct injection technique. We developed two scales to assess barriers and adherence to the correct technique. METHODS: Two item pools were created to assess barriers to insulin injections (barriers scale) and adherence to the correct technique (adherence scale). In an evaluation study, participants completed the two newly created scales, as well as other questionnaires used for criterion validity. Exploratory factor analysis, correlational analysis, and receiver operating characteristics analysis were computed to analyze the validity of the scales. RESULTS: A total of 313 people with type 1 and type 2 diabetes using an insulin pen for insulin injections participated. For the barriers scale, 12 items were selected achieving a reliability of 0.74. The factor analysis revealed three factors namely emotional, cognitive, and behavioral barriers. For the adherence scale, nine items were selected achieving a reliability of 0.78. Both scales showed significant associations with diabetes self-management, diabetes distress, diabetes acceptance, and diabetes empowerment. Receiver operating characteristics analysis showed significant area under the curves for both scales in classifying people with current skin irritations. CONCLUSIONS: Reliability and validity of the two scales assessing barriers and adherence to insulin injection technique were demonstrated. The two scales can be used in clinical practice to identify persons in need of education in insulin injection technique.

Time With Diabetes Distress and Glycemia-Specific Distress: New Patient-Reported Outcome Measures for the Psychosocial Burden of Diabetes Using Ecological Momentary Assessment in an Observational Study.

OBJECTIVE: To estimate time with diabetes distress using ecological momentary assessment (EMA) in people with type 1 diabetes and analyze its associations with glycemic management based on continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS: We used EMA to assess diabetes distress in a sample of recently hospitalized adults with type 1 diabetes once a day for 17 consecutive days in an ambulatory setting. Additionally, participants were asked daily about hypoglycemia distress (<70 mg/dL [3.9 mmol/L]), hyperglycemia distress (>180 mg/dL [10 mmol/L]), and variability distress (glucose fluctuations). Per person, the percentage of days with elevated distress was calculated (time with distress). Multilevel regression was used to analyze daily associations of distress ratings with CGM-derived parameters. EMA-derived associations between diabetes distress and glycemic outcomes were compared with questionnaire-derived associations. RESULTS: Data of 178 participants were analyzed. Participants spent a mean (SD) of days in a state of diabetes distress, 54.6 ± 26.0% in hyperglycemia distress, 45.2 ± 27.5% in variability distress, and 23.0 ± 19.3% in hypoglycemia distress. In multilevel analyses, higher daily ratings of diabetes distress were significantly associated with hyperglycemia (ß = 0.41). Results showed high between-person variability as explanation of variance of the models ranged between 22.2 and 98.8%. EMA-derived diabetes distress showed a significant association with mean glucose (r = 0.25), while questionnaire-based diabetes distress did not (r = 0.10). Prospectively, time with diabetes distress was associated with HbA1c at the 3-month follow-up (r = 0.27), while questionnaire-based distress showed no association (r = 0.11). CONCLUSIONS: Time with distress as assessed with EMA showed a comparative advantage over distress as determined by questionnaire-based assessment of diabetes distress regarding associations with glycemic management.

The burden of type 2 diabetes in Europe: Current and future aspects of insulin treatment from patient and healthcare spending perspectives.

Due to the progressive nature of type 2 diabetes (T2DM), initiation of insulin therapy is very likely in the disease continuum. This article aims at highlighting the current situation with regard to insulin therapy in people with T2DM in Europe and at presenting the associated unmet need. Challenges for both people with T2DM and healthcare professionals include clinical inertia also derived from fear of hypoglycaemia, weight gain and injections as well as increased need for a comprehensive diabetes management. We compare national and international guidelines and recommendations for the initiation and intensification of insulin therapy with the real-world situation in six European countries, demonstrating that glycaemic targets are only met in a minority of people with T2DM on insulin therapy. Furthermore, this work evaluates currently recorded numbers of people with T2DM treated with insulin in Europe, the proportion not achieving the stated glycaemic targets and thus in need to enhance insulin therapy e.g. by a change in means of insulin delivery including, but not limited to, insulin pens, wearable mealtime insulin delivery patches, patch pumps, and conventional insulin pumps with continuous subcutaneous insulin infusion.

Population pharmacokinetics and target attainment analysis of moxifloxacin in patients with diabetic foot infections.

The objective of this study was to provide a pharmacokinetic/pharmacodynamic (PK/PD) analysis of moxifloxacin in patients with diabetic foot infections (DFI). The plasma concentration-time courses were determined in 50 DFI patients on day 1 and 3 after intravenous moxifloxacin 400 mg once-daily. A two-compartment population pharmacokinetic model was developed, identifying as covariates total body weight on central and peripheral volume of distribution (V1, V2) and ideal body weight on clearance (CL), respectively. For a 70 kg patient V1 was 68.1 L (interindividual variability, CV: 27.4%), V2 44.6 L, and CL 12.1 L/h (25.6%). Simulations were performed to calculate the probability of target attainment (PTA) for Gram-positive and Gram-negative pathogens with fAUC/MIC targets of ≥30 and ≥100, respectively. PTA was 0.68-1 for susceptible (MIC ≤0.5 mg/L according to EUCAST) Gram-positive, but <0.25 for Gram-negative pathogens with MIC ≥0.25 mg/L. With the exception of the first 24 hours of therapy, obesity affected PTA only marginally. Pharmacokinetic parameters in DFI patients were similar to those reported for healthy volunteers, indicating the appropriateness of the standard dose of moxifloxacin. Overall clinical efficacy has been shown previously, but PTA is limited in a subpopulation infected with formally susceptible Gram-negative pathogens close to the EUCAST breakpoint.

Within-trial economic evaluation of diabetes-specific cognitive behaviour therapy in patients with type 2 diabetes and subthreshold depression.

BACKGROUND: Despite the high prevalence of subthreshold depression in patients with type 2 diabetes, evidence on cost-effectiveness of different therapy options for these patients is currently lacking. METHODS/DESIGN: Within-trial economic evaluation of the diabetes-specific cognitive behaviour therapy for subthreshold depression. Patients with diabetes and subthreshold depression are randomly assigned to either 2 weeks of diabetes-specific cognitive behaviour group therapy (n = 104) or to standard diabetes education programme only (n = 104). Patients are followed for 12 months. During this period data on total health sector costs, patient costs and societal productivity costs are collected in addition to clinical data. Health related quality of life (the SF-36 and the EQ-5D) is measured at baseline, immediately after the intervention, at 6 and at 12 months after the intervention. Quality adjusted life years (QALYs), and cumulative costs will be estimated for each arm of the trial. Cost-effectiveness of the diabetes-specific cognitive behaviour group therapy will be analysed from the perspective of the German statutory health insurance and from the societal perspective. To this end, incremental cost-effectiveness ratio (ICER) in terms of cost per QALY gained will be calculated. DISCUSSION: Some methodological issues of the described economic evaluation are discussed. TRIAL REGISTRATION: The trial has been registered at the Clinical Trials Register (NCT01009138).