Relaxation training significantly reduced blood glucose levels in patients with type 1 diabetes mellitus.

PURPOSE/OBJECTIVE: The present study was designed to test whether adding a relaxation training technique to the medical treatment of patients with type 1 diabetes mellitus could, adjusting for the non-specific factors of therapy, lead to an improvement in the patients' condition. METHOD: Forty-six participants were randomly allocated either to an experimental (intervention) group, receiving weekly sessions of relaxation training, or to a control group (placebo) receiving weekly blood circulation training exercises. Measures included the State and Trait Anxiety Inventory, blood glucose levels, high-density lipoprotein levels, cholesterol levels, body weight, HbA1c levels, the Mood Adjective Checklist (MACL), a diary checklist, and urine glucose levels. Assessment of psychological and physiological parameters was conducted before and upon completion of the intervention (8 weeks). RESULTS: Trait anxiety and the main metabolic measurement of blood glucose levels and HbA1C revealed significant differences over time, predominantly among patients in the intervention group. CONCLUSIONS: Relaxation techniques as an adjunct to medical treatment are a useful tool for patients with type 1 diabetes mellitus.

Improvement of metabolic control after 3-month use of real-time continuous glucose monitoring in patients with type 1 diabetes: a multicenter study in Greece.

PURPOSE: To assess the efficacy of a real-time continuous glucose monitoring (RT-CGM) system added to insulin pump therapy for 3 months, in sub-optimally controlled adults with type 1 diabetes mellitus (T1D). METHODS: This was a prospective, multicenter, non-randomized, post-market release study. A total of 43 adult patients with T1D on insulin pump therapy and inadequate glycemic control (HbA1c > 7.0%) participated in the study. The primary endpoint was the change from baseline HbA1c levels. Secondary objectives were to evaluate the impact of the RT-CGM system on glucose variability, daily insulin requirements, and the frequency of hypoglycemic and ketoacidosis events. RESULTS: At 3 months, the baseline HbA1c values decreased from 8.0 (7.6, 8.7) to 7.1 (6.7, 8.0) % (p < 0.001). Nineteen participants (44.2%) had a posttreatment HbA1c level ≤ 7%. Average total daily insulin requirements, as well as the average number of insulin boluses per day, increased significantly after the use of the RT-CGM system. The number of hypoglycemic events recorded did not differ between the first week and last week of RT-CGM usage, while no severe hypoglycemic episodes, ketoacidosis events, or hospitalizations related to diabetes occurred during the 3-month follow-up period. CONCLUSION: Addition of a RT-CGM system to insulin pump therapy for 3 months in inadequately controlled patients with T1D resulted in improved HbA1c levels, without increasing the risk of hypoglycemic events.

Evaluation of insulin initiation on resource utilization and direct costs of treatment over 12 months in patients with type 2 diabetes in Europe: results from INSTIGATE and TREAT observational studies.

OBJECTIVES: To describe the changes in resource utilization in seven European countries (Germany, Greece, Portugal, Romania, Sweden, Spain, and Turkey) and direct costs in four European countries (Germany, Spain, Sweden, and Greece) over the first 12 months of insulin treatment in patients with type 2 diabetes mellitus (T2DM). METHODS: INSTIGATE and TREAT (2005-2010) were non-interventional, prospective, observational studies in patients with T2DM and initiating insulin for the first time. A 6-month retrospective data capture was conducted at baseline (insulin initiation) followed by prospective data collections at ∼3, 6, and 12 months. Statistical analyses were descriptive; estimated costs are presented as nominal values. RESULTS: This study presents data for 1450 patients. Overall, in the first 6 months after insulin initiation, the use and cost of blood glucose monitoring and insulin increased, while the cost of oral diabetic medication decreased. Contributors to total direct costs differed between countries. Ranges of total mean direct costs over the 6-month period before insulin initiation were €489.10-€658.50 (Greece-Spain); 0-6 months after insulin initiation, €573.40-€1084.70 (Greece-Spain); and 6-12 months after insulin initiation, €495.80-€859.30 (Greece-Germany). Thus, the mean cost of treatment increased in all countries in the first 6 months after insulin initiation and then returned to baseline except in Germany. LIMITATIONS: Overall, 15% of patients were lost to follow-up over 12 months. Costs were not pro-rated to account for variation of visits. Participating centres may not have been fully representative of all levels of care. CONCLUSIONS: Contributors to total cost differed between countries, potentially reflecting local clinical practice patterns and insulin regimens. In each country, mean direct total costs of T2DM care increased during the first 6 months after insulin initiation and decreased thereafter.

Clinical outcomes and costs for patients with type 2 diabetes mellitus initiating insulin therapy in Greece: two-year experience from the INSTIGATE study.

AIMS: To evaluate the quality of metabolic control, clinical outcomes, resource costs, and quality of life among patients with type 2 diabetes mellitus (T2DM), who initiated insulin for the first time as part of routine clinical practice. METHODS: The INSTIGATE study is a prospective, multicentric, observational study of patients initiating insulin treatment. This sub-cohort analysis focuses on Hellenic outcomes. RESULTS: At baseline, 263 Greek patients were enrolled just before initiating insulin for the first time. At the 6-month visit, 237 patients (90.1%) remained and consented to an additional 18-month observation period. In these 237 extension patients, over the 24-month post-initiation period, HbA1c (mean(SD)) decreased from 9.7%(1.6%) to 7.1%(0.9%) and body weight and BMI increased (+3(6)kg and +1.1(2.2)kg/m(2), respectively). At each post-baseline visit approximately one in five patients reported ≥1 episodes of hypoglycaemia in the preceding 3-6 months. Median total costs fluctuated from 438€ at baseline to 538€ up to 6 months and 451€ at 24 months; mean costs were 496(383)€, 573(276)€ and 485(247)€, respectively. CONCLUSIONS: In this cohort, insulin treatment seems to be effective with little long-term impact on cost. Findings should be interpreted in the context of an observational study.

A combined urodynamic and electrophysiological study of diabetic cystopathy.

AIMS: The aim of this study is to compare urodynamics and electrophysiological studies in the diagnosis of diabetic cystopathy. MATERIALS AND METHODS: In this prospective study are included twenty six patients with diabetes mellitus diagnosed at least since 5 years; 17 patients with diabetes type II and 9 with type I. They were divided in two groups in respect to lower urinary tract symptoms (LUTS) and signs suggestive of lower urinary tract dysfunction (LUTD) according to the ICS standardization. Patients with LUTS/LUTD were included in Group A and patients without LUTS/LUTD in Group B. Patients underwent different studies: urodynamic, somatosensory evoked potentials (SSEP) of tibial and pudendal nerves, bulbocavernosus reflex (BCR), bulbocavernosus muscles' electromyography and motor evoked potentials after transcranial magnetic stimulation to indirectly investigate bladder's innervation. RESULTS: Abnormal urodynamics were found in 13 patients of group A (92.9%) and in 5 of group B (47.1%). This difference was statistically significant (P=0.009). Abnormally prolonged latency of P40 of tibial SSEP was found in 11 patients of group A (78.6%) and in 4 of group B (33.3%) and this difference was also statistically significant (P=0.04). Differences between the two groups concerning: i) peripheral polyneuropathy; ii) pudendal SSEP, iii) dysfunction of central nervous system and iv) abnormal BCR were not statistically significant. CONCLUSION: The study of tibial SSEP is an easily performed test and it is well correlated to abnormal urodynamics in diabetic patients with and without LUTD/LUTS.