Background:Inaccurate blood glucsoe monitoring systems (BGMSs) can lead to adverse health effects. The Diabetes Technology Society (DTS) Surveillance Program for cleared BGMSs is intended to protect people with diabetes from inaccurate, unreliable BGMS products that are currently on the market in the United States. The Surveillance Program will provide an independent assessment of the analytical performance of cleared BGMSs.Methods:The DTS BGMS Surveillance Program Steering Committee included experts in glucose monitoring, surveillance testing, and regulatory science. Over one year, the committee engaged in meetings and teleconferences aiming to describe how to conduct BGMS surveillance studies in a scientifically sound manner that is in compliance with good clinical practice and all relevant regulations.Results:A clinical surveillance protocol was created that contains performance targets and analytical accuracy-testing studies with marketed BGMS products conducted by qualified clinical and laboratory sites. This protocol entitled “Protocol for the Diabetes Technology Society Blood Glucose Monitor System Surveillance Program” is attached as supplementary material.Conclusion:This program is needed because currently once a BGMS product has been cleared for use by the FDA, no systematic postmarket Surveillance Program exists that can monitor analytical performance and detect potential problems. This protocol will allow identification of inaccurate and unreliable BGMSs currently available on the US market. The DTS Surveillance Program will provide BGMS manufacturers a benchmark to understand the postmarket analytical performance of their products. Furthermore, patients, health care professionals, payers, and regulatory agencies will be able to use the results of the study to make informed decisions to, respectively, select, prescribe, finance, and regulate BGMSs on the market.
Differential care seeking for boys and girls is not seen in Thatta despite clear differences in mortality ratios. This calls for more creative research to identify pathways for gender differential in child mortality. Factors identified as influencing child health care and amenable to modification include poverty alleviation and girls' education.
Medication persistence is imperative for successful treatment of type 2 diabetes (T2D). Prior research has shown that discontinuation of prescribed medication within the first year is common for number of chronic disease treatments and that this is associated with poor clinical outcomes. We performed a retrospective, observational study using claims data from the Truven Health MarketScan® Commercial and Medicare Supplemental Databases (2013-2016) to identify T2D patients initiating T2D therapy. Patients with at least one diagnosis for T2D and one outpatient pharmacy claim for a T2D medication preceded by 12 months without such medications were included. Patients were required to have at least 12 months of continuous enrollment in the database before and after the therapy initiation date. The primary outcome was initial treatment regimen discontinuation, defined as a gap of at least 45 days with no T2D medications on hand. Re-starting therapy with any T2D medication from the discontinuation date through the end of the 12-month follow-up was also assessed. Those with continuous treatment were censored at the end of the 12-month follow-up period. A total of 324,136 patients initiating therapy were identified. The sample was 46% female and had an average age of 55 years. Following initiation, 31% of patients discontinued within the first 3 months, 44% within 6 months and 58% within 12 months. Among those who discontinued within the 12-month follow-up, 27% restarted therapy within 60 days, and 39% re-started therapy anytime during the 12-month follow-up. Those who discontinued and re-started therapy spent a mean of 107 days without treatment on hand. This study provides real-world evidence that a majority of T2D medication patients discontinue within one year of initiation. Interventions aimed at improving treatment persistence should be targeted early after initiation to avoid gaps in therapy and associated clinical consequences. Disclosure W.T. Cefalu: None. T. Darsow: None. M. Petersen: None. L. Palmer: None. E. Thiel: None. L. Latts: Other Relationship; Self; Medtronic, Novo Nordisk Inc., Sanofi.
This chapter summarizes the major Web-based information, education, and research resources on diabetes prevention and control that are available to public health researchers and practitioners from organizations in the federal government, voluntary and professional organizations, and the private sector. Informational and educational resources are described for public health researchers and practitioners and for public and patient audiences.
Data from placebo controlled, randomized clinical trials (RCTs) have demonstrated cardio-protective effects of certain diabetes therapy classes, including sodium-glucose co-transporter-2 inhibitors (SGLT2i) and glucagon receptor agonists (GLP-1RA). However, the majority of these trials made comparisons to placebo and there is limited data on head to head comparisons between specific classes. We performed an observational cohort study using the Truven Health MarketScan® Research Databases (2013-2016) to compare the risk of cardiovascular events between patients initiating treatment with SGLT2is, dipeptidyl peptidase-4 inhibitors (DPP-4is) and GLP-1-RAs vs. sulfonylureas (SUs) in a real-world setting. Propensity score weighting and doubly robust methods (boosting and Poisson regression) were used to control for differences in baseline characteristics. The primary study outcomes were hospitalization for congestive heart failure, acute myocardial infarction, stroke and a composite of all three. Lower extremity amputations were also examined. The relative risks of events in the 12 months before and after treatment initiation were compared to generate relative risk ratios. Protective effects of SGLT2is compared to SUs were observed (Table). Interestingly, there was also a protective effect of DPP-4is on individual outcomes compared to SUs in contrast to DPP-4i vs. placebo in RCTs. Disclosure E. Thiel: None. W.D. Marder: Employee; Self; IBM. W.T. Cefalu: None. T. Darsow: None. M. Petersen: None. L. Latts: Other Relationship; Self; Medtronic, Novo Nordisk Inc., Sanofi.
SETTING: Human mobility contributes to the spread of infectious diseases. South Africa has a long history of internal labor migration and a high burden of TB.METHODS: People newly diagnosed with TB in the Vhembe and Waterberg Districts of Limpopo answered a questionnaire regarding geographic movement over the past year. Participants were classified as ‘highly mobile’ (spending more than 30 nights at a residence other than their primary residence in the past year, or being ≥250 km from their primary residence at the time of the interview) or ‘less mobile’. We explored associations between sociodemographic characteristics and high mobility, and between mobility and time to presentation at a clinic.RESULTS: Of the 717 participants included, 185 (25.7%) were classified as ‘highly mobile’. Factors associated with high mobility included living with someone outside of Limpopo Province, HIV-positive status (men only), and current smoking (men only). Highly mobile individuals had similar care-seeking behavior as less mobile individuals (adjusted time ratio 0.9, 95% CI 0.6–1.2, P = 0.304)CONCLUSION: Highly mobile people with TB in Limpopo Province were more likely to live with people from outside the province, smoke, and have HIV. These patients had similar delays in seeking care as less mobile individuals.
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