Individualized Treatment Targets for T2D and Hypertension
Individualized Treatment Targets for T2D and Hypertension
DIALOGUE is an ongoing, prospective, observational, non‐interventional, multi-center disease registry with a follow-up of up to 24 months (i.e., 6, 12 and 24 months) in Germany. Diabetologists and primary care physicians are in charge of continued patient enrollment at selected centers, which were chosen from a database (Stiftung Institut für Herzinfarktforschung) to be representative of ambulatory care for diabetes and hypertension. This registry is being conducted in accordance with the Declaration of Helsinki and adheres to the principles of Good Epidemiology Practice. Moreover this investigation has followed applicable regulatory requirements, and the study protocol was approved by the ethics committee of the Ruhr University (Bochum, Germany). In addition, all patients provided written informed consent, and DIALOGUE was registered in the database of the Verband forschender Arzneimittelhersteller (http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb). The study protocol, as well as primary and secondary objectives of DIALOGUE, have been previously published in detail. Decisions regarding individual therapies and treatment goals (HbA1c and BP) were made solely by the attending physician based on their clinical assessment.
Patients were consecutively enrolled based on the following criteria: at least 18 years old; T2DM and manifested comorbid hypertension; current use of oral mono‐ or dual combination antidiabetic therapy; treating physician considered blood glucose lowering medication as inadequate and/or not safe/tolerable; the physician added an additional oral drug or switched drug treatment to achieve glycemic control (excluding glucagon-like peptide [GLP-1] analogues and insulin). Patients were not eligible for inclusion if any of the following criteria applied: current participation in a randomized controlled trial; not under regular supervision of the treating physician during the study; use of GLP-1 analogues or insulin before enrollment; treated with aliskiren in a dual renin-angiotensin-aldosterone system (RAAS) blockade; pregnancy; diabetes secondary to malnutrition, infection or surgery; maturity onset diabetes of the young; and known cancer.
Data were recorded using a web-based electronic case report form (eCRF). Among other information, the following information was collected: patient characteristics (basic characteristics, medical history, and comorbidities); medical therapy for secondary prevention of cardio‐vascular complications; glucose profile (fasting glucose, post‐prandial glucose, HbA1c); BP; and body mass index (BMI). Office BP was assessed with standard oscillometric devices available at the physician's office with a calibration validation. Data quality was ensured upon eCRF entry, prior to creation of the analysis data set, and through on-site monitoring (2% of the sites randomly selected).
Continuous variables were summarized using standard statistics (i.e., mean, standard deviation, minimum, median, maximum, lower and upper quartile), whereas percentages were calculated for categorical data. Comparisons between treatment groups were performed using Pearson's chi-squared test for categorical variables and the Kruskal–Wallis test for continuous measures. Predictors for target group selection were identified through multivariate analysis. All statistical analyses were performed using SAS (release 9.2 or higher; Cary, NC, USA). P-values ≤ 0.05 were considered to be significant.
Methods
Study Design
DIALOGUE is an ongoing, prospective, observational, non‐interventional, multi-center disease registry with a follow-up of up to 24 months (i.e., 6, 12 and 24 months) in Germany. Diabetologists and primary care physicians are in charge of continued patient enrollment at selected centers, which were chosen from a database (Stiftung Institut für Herzinfarktforschung) to be representative of ambulatory care for diabetes and hypertension. This registry is being conducted in accordance with the Declaration of Helsinki and adheres to the principles of Good Epidemiology Practice. Moreover this investigation has followed applicable regulatory requirements, and the study protocol was approved by the ethics committee of the Ruhr University (Bochum, Germany). In addition, all patients provided written informed consent, and DIALOGUE was registered in the database of the Verband forschender Arzneimittelhersteller (http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb). The study protocol, as well as primary and secondary objectives of DIALOGUE, have been previously published in detail. Decisions regarding individual therapies and treatment goals (HbA1c and BP) were made solely by the attending physician based on their clinical assessment.
Patients
Patients were consecutively enrolled based on the following criteria: at least 18 years old; T2DM and manifested comorbid hypertension; current use of oral mono‐ or dual combination antidiabetic therapy; treating physician considered blood glucose lowering medication as inadequate and/or not safe/tolerable; the physician added an additional oral drug or switched drug treatment to achieve glycemic control (excluding glucagon-like peptide [GLP-1] analogues and insulin). Patients were not eligible for inclusion if any of the following criteria applied: current participation in a randomized controlled trial; not under regular supervision of the treating physician during the study; use of GLP-1 analogues or insulin before enrollment; treated with aliskiren in a dual renin-angiotensin-aldosterone system (RAAS) blockade; pregnancy; diabetes secondary to malnutrition, infection or surgery; maturity onset diabetes of the young; and known cancer.
Data Collection and Quality Assurance
Data were recorded using a web-based electronic case report form (eCRF). Among other information, the following information was collected: patient characteristics (basic characteristics, medical history, and comorbidities); medical therapy for secondary prevention of cardio‐vascular complications; glucose profile (fasting glucose, post‐prandial glucose, HbA1c); BP; and body mass index (BMI). Office BP was assessed with standard oscillometric devices available at the physician's office with a calibration validation. Data quality was ensured upon eCRF entry, prior to creation of the analysis data set, and through on-site monitoring (2% of the sites randomly selected).
Statistical Analyses
Continuous variables were summarized using standard statistics (i.e., mean, standard deviation, minimum, median, maximum, lower and upper quartile), whereas percentages were calculated for categorical data. Comparisons between treatment groups were performed using Pearson's chi-squared test for categorical variables and the Kruskal–Wallis test for continuous measures. Predictors for target group selection were identified through multivariate analysis. All statistical analyses were performed using SAS (release 9.2 or higher; Cary, NC, USA). P-values ≤ 0.05 were considered to be significant.
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