Results of glycated hemoglobin during treatment with insulin analogues dispensed in the public health system of Federal District in Brazil

Background: Diabetes treatment requires specialized multi-professional teams, supplies for blood glucose monitoring and training for self-injections of human insulin or insulin analogues. The State Health Secretariat of the Federal District (SHS-FD) has dispensed insulin analogues by means of clinical validated protocols since 2004. However, data on outcomes of follow-up are still unknown. Objective: To evaluate the results of glycated hemoglobin (HbA1c) among diabetic patients treated with insulin analogues. Methods: It is a retrospective cohort study involving data of type 1(DM1) and type 2 diabetes (DM2) patients 18 years old and above who were registered to participate at the insulin analogues dispense program of the SHS-FD. Evaluation of criteria of insulin treatment continuity was based on HbA1c values achieved in the follow-up period: in the target, <7 %, patients between 18 and 65 years old; <8 % for those above 65 years old; out of target, when values were superior these cut off points for both age groups; and minimum 0.5 % reduction of two HbA1c values during follow-up. Results: Two hundred and fifteen formularies were analyzed: Type 2 patients (63.7 %) and female sex were the most prevalent (63.7 %), (p < 0.05). Mean age and SD were 41.5 ± 23.5 years among DM1 and 60.5 ± 28.5 in those with DM2. HbA1c in the target was found in 26 %, 48 % were out of target and 26 % achieved 0.5 % minimum reduction in HbA1c value (p < 0.05). The main clinical characteristics associated with HbA1c found to be in the target were older age (>65 years), more than three medical appointments in the follow-up and lower mean HbA1c in the patient selection for inclusion criteria in the dispense program (p < 0.05). Conclusion: The low number of patients using insulin analogues in the target group, considered to be in good control, implies the need to reevaluate both level of patients self-care knowledge and glucose monitoring prior their inclusion in the insulin analogue dispense program. Reinforcement and training of health professional teams in enrollment procedures should be on mandatory basis to avoid protocol failure or deviations

Short-acting insulin analogues versus regular human insulin on postprandial glucose and hypoglycemia in type 1 diabetes mellitus : a systematic review and meta-analysis

Introduction: Strict glucose control using multiple doses of insulin is the standard treatment for type 1 diabetes mellitus (T1DM), but increased risk of hypoglycemia is a frequent drawback. Regular insulin in multiple doses is important for achieving strict glycemic control for T1DM, but short-acting insulin analogues may be better in reducing hypoglycemia and postprandial glucose levels. Objective: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to assess the effects of short-acting insulin analogues vs regular human insulin on hypoglycemia and postprandial glucose in patients with T1DM. Methods: Searches were run on the electronic databases MEDLINE, Cochrane-CENTRAL, EMBASE, ClinicalTrials.gov, LILACS, and DARE for RCTs published until August 2017. To be included in the study, the RCTs had to cover a minimum period of 4 weeks and had to assess the effects of short-acting insulin analogues vs regular human insulin on hypoglycemia and postprandial glucose levels in patients with T1DM. Two independent reviewers extracted the data and assessed the quality of the selected studies. The primary outcomes analyzed were hypoglycemia (total episodes, nocturnal hypoglycemia, and severe hypoglycemia) and postprandial glucose (at all times, after breakfast, after lunch, and after dinner). Glycated hemoglobin (HbA1c) levels and quality of life were considered secondary outcomes. The risk of bias of each RCT was assessed using the Cochrane Collaboration Risk of Bias table, while the quality of evidence for each outcome was assessed using the GRADEpro software. The pooled mean difference in the number of hypoglycemic episodes and postprandial glucose between short-acting insulin analogues vs. regular human insulin was calculated using the random-effects model. Results: Of the 2897 articles retrieved, 22 (6235 patients) were included. Short-acting insulin analogues were associated with a decrease in total hypoglycemic episodes (risk rate 0.93, 95% CI 0.87–0.99; 6235 patients; I2 = 81%), nocturnal hypoglycemia (risk rate 0.55, 95% CI 0.40–0.76, 1995 patients, I2 = 84%), and severe hypoglycemia (risk rate 0.68, 95% CI 0.60–0.77; 5945 patients, I2 = 0%); and with lower postprandial glucose levels (mean difference/MD − 19.44 mg/dL; 95% CI − 21.49 to − 17.39; 5031 patients, I2 = 69%) and lower HbA1c (MD − 0,13%; IC 95% − 0.16 to − 0.10; 5204 patients; I2 = 73%) levels. Conclusions: Short-acting insulin analogues are superior to regular human insulin in T1DM patients for the following outcomes: total hypoglycemic episodes, nocturnal hypoglycemia, severe hypoglycemia, postprandial glucose, and HbA1c

Health-related quality of life in patients with type 1 diabetes mellitus in the different geographical regions of Brazil : data from the Brazilian Type 1 Diabetes Study Group

Background: In type 1 diabetes mellitus (T1DM) management, enhancing health-related quality of life (HRQoL) is as important as good metabolic control and prevention of secondary complications. This study aims to evaluate possible regional differences in HRQoL, demographic features and clinical characteristics of patients with T1DM in Brazil, a country of continental proportions, as well as investigate which variables could influence the HRQoL of these individuals and contribute to these regional disparities. Methods: This was a retrospective, cross-sectional, multicenter study performed by the Brazilian Type 1 Diabetes Study Group (BrazDiab1SG), by analyzing EuroQol scores from 3005 participants with T1DM, in 28 public clinics, among all geographical regions of Brazil. Data on demography, economic status, chronic complications, glycemic control and lipid profile were also collected. Results: We have found that the North-Northeast region presents a higher index in the assessment of the overall health status (EQ-VAS) compared to the Southeast (74.6 ± 30 and 70.4 ± 19, respectively; p < 0.05). In addition, North- Northeast presented a lower frequency of self-reported anxiety-depression compared to all regions of the country (North-Northeast: 1.53 ± 0.6; Southeast: 1.65 ± 0.7; South: 1.72 ± 0.7; Midwest: 1.67 ± 0.7; p < 0.05). These findings could not be entirely explained by the HbA1c levels or the other variables examined. Conclusions: Our study points to the existence of additional factors not yet evaluated that could be determinant in the HRQoL of people with T1DM and contribute to these regional disparities

Regional differences in clinical care among patients with type 1 diabetes in Brazil: Brazilian Type 1 Diabetes Study Group

Background\ud To determine the characteristics of clinical care offered to type 1 diabetic patients across the four distinct regions of Brazil, with geographic and contrasting socioeconomic differences. Glycemic control, prevalence of cardiovascular risk factors, screening for chronic complications and the frequency that the recommended treatment goals were met using the American Diabetes Association guidelines were evaluated.\ud \ud Methods\ud This was a cross-sectional, multicenter study conducted from December 2008 to December 2010 in 28 secondary and tertiary care public clinics in 20 Brazilian cities in north/northeast, mid-west, southeast and south regions. The data were obtained from 3,591 patients (56.0% females and 57.1% Caucasians) aged 21.2 ± 11.7 years with a disease duration of 9.6 ± 8.1 years (<1 to 50 years).\ud \ud Results\ud Overall, 18.4% patients had HbA1c levels <7.0%, and 47.5% patients had HbA1c levels ≥ 9%. HbA1c levels were associated with lower economic status, female gender, age and the daily frequency of self-blood glucose monitoring (SBGM) but not with insulin regimen and geographic region. Hypertension was more frequent in the mid-west (32%) and north/northeast (25%) than in the southeast (19%) and south (17%) regions (p<0.001). More patients from the southeast region achieved LDL cholesterol goals and were treated with statins (p<0.001). Fewer patients from the north/northeast and mid-west regions were screened for retinopathy and nephropathy, compared with patients from the south and southeast. Patients from the south/southeast regions had more intensive insulin regimens than patients from the north/northeast and mid-west regions (p<0.001). The most common insulin therapy combination was intermediate-acting with regular human insulin, mainly in the north/northeast region (p<0.001). The combination of insulin glargine with lispro and glulisine was more frequently used in the mid-west region (p<0.001). Patients from the north/northeast region were younger, non-Caucasian, from lower economic status, used less continuous subcutaneous insulin infusion, performed less SBGM and were less overweight/obese (p<0.001).\ud \ud Conclusions\ud A majority of patients, mainly in the north/northeast and mid-west regions, did not meet metabolic control goals and were not screened for diabetes-related chronic complications. These results should guide governmental health policy decisions, specific to each geographic region, to improve diabetes care and decrease the negative impact diabetes has on the public health system.We thank Mrs. Karianne Aroeira Davidson, Mrs. Anna Maria Ferreira, Mrs. Elisangela Santos and Sandro Sperandei for their technical assistance.This work was supported by grants from Farmanguinhos/Fundação Oswaldo Cruz/National Health Ministry, the Brazilian Diabetes Society, Fundação do Amparo à Pesquisa do Estado do Rio de Janeiro, and Conselho Nacional de Desenvolvimento Científico e Tecnológico do Brasil

Annual direct medical costs of diabetic foot disease in Brazil : a cost of illness study

The aim of this study was to estimate the annual costs for the treatment of diabetic foot disease (DFD) in Brazil. We conducted a cost-of-illness study of DFD in 2014, while considering the Brazilian Public Healthcare System (SUS) perspective. Direct medical costs of outpatient management and inpatient care were considered. For outpatient costs, a panel of experts was convened from which utilization of healthcare services for the management of DFD was obtained. When considering the range of syndromes included in the DFD spectrum, we developed four well-defined hypothetical DFD cases: (1) peripheral neuropathy without ulcer, (2) non-infected foot ulcer, (3) infected foot ulcer, and (4) clinical management of amputated patients. Quantities of each healthcare service was then multiplied by their respective unit costs obtained from national price listings. We then developed a decision analytic tree to estimate nationwide costs of DFD in Brazil, while taking into the account the estimated cost per case and considering epidemiologic parameters obtained from a national survey, secondary data, and the literature. For inpatient care, ICD10 codes related to DFD were identified and costs of hospitalizations due to osteomyelitis, amputations, and other selected DFD related conditions were obtained from a nationwide hospitalization database Direct medical costs of DFD in Brazil was estimated considering the 2014 purchasing power parity (PPP) (1 Int$= 1.748 BRL).We estimated that the annual direct medical costs of DFD in 2014 was Int$ 361 million, which denotes 0.31% of public health expenses for this period. Of the total, Int$27.7 million (13$ 333.5 million (87%) for outpatient care. Despite using different methodologies to estimate outpatient and inpatient costs related to DFD, this is the first study to assess the overall economic burden of DFD in Brazil, while considering all of its syndromes and both outpatients and inpatients. Although we have various reasons to believe that the hospital costs are underestimated, the estimated DFD burden is significant. As such, public health preventive strategies to reduce DFD related morbidity and mortality and costs are of utmost importance