Cognitive Behavioral Therapy Versus Sertraline in Patients With Depression and Poorly Controlled Diabetes: The Diabetes and Depression (DAD) Study

OBJECTIVE This study compared the long-term efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) with sertraline in patients with diabetes and depression who initially responded to short-term depression treatment. RESEARCH DESIGN AND METHODS A randomized controlled single-blind trial was conducted in 70 secondary care centers across Germany comparing 12 weeks of CBT with sertraline in 251 patients with type 1 or 2 diabetes (mean HbA1c 9.3%, 78 mmol/mol) and major depression (Structured Clinical Interview for DSM-IV [SCID]). After 12 weeks, treatment responders (≥50% reduction Hamilton Depression Rating Scale [HAMD-17]) were included in the 1-year study phase where CBT p…

Study protocol of the Diabetes and Depression Study (DAD): a multi-center randomized controlled trial to compare the efficacy of a diabetes-specific cognitive behavioral group therapy versus sertraline in patients with major depression and poorly controlled diabetes mellitus

Background Depression is common in diabetes and associated with hyperglycemia, diabetes related complications and mortality. No single intervention has been identified that consistently leads to simultaneous improvement of depression and glycemic control. Our aim is to analyze the efficacy of a diabetes-specific cognitive behavioral group therapy (CBT) compared to sertraline (SER) in adults with depression and poorly controlled diabetes. Methods/Design This study is a multi-center parallel arm randomized controlled trial currently in its data analysis phase. We included 251 patients in 70 secondary care centers across Germany. Key inclusion criteria were: type 1 or 2 diabetes, major depress…

Associations of Time in Range and Other Continuous Glucose Monitoring–Derived Metrics With Well-Being and Patient-Reported Outcomes: Overview and Trends

Time in glucose ranges is increasingly relevant for research and clinical practice. Whereas the clinical validity of these metrics has been demonstrated with regard to long-term complications, their associations with patient-reported outcomes such as well-being, diabetes distress, and fear of hypoglycemia remain an open research question. This article reviews existing evidence on links between times in glycemic ranges and patient-reported outcomes. It also describes a novel research approach of using ecological momentary assessment to analyze on a more granular level in real time possible associations of these parameters of glycemic control and patient-reported outcomes. Such an approach co…

40(th) EASD Annual Meeting of the European Association for the Study of Diabetes : Munich, Germany, 5-9 September 2004

Patient-Reported Outcomes and Continuous Glucose Monitoring: Can We Do Better With Artificial Pancreas Devices?

Patient-reported outcomes (PROs) assess a person’s experience, feelings, and thoughts about both their condition and its treatment. PROs are able to contribute to a benefit assessment of new medical products by introducing the patients’ subjective evaluation of medical products into the evaluation process. Thus, PROs are also the cornerstone of medical product development for understanding patients’ perceptions on medical products and/or its benefit assessment. In the past 15 years, PROs were also evaluated in most clinical trials performed with continuous glucose monitoring systems. However, in its recent evaluation of such trials, the German Institute for Quality and Efficiency in Health …

hs-CRP Predicts Improvement in Depression in Patients With Type 1 Diabetes and Major Depression Undergoing Depression Treatment: Results From the Diabetes and Depression (DAD) Study

hs-CRP is elevated in depression (1), but evidence on decreases of hs-CRP during depression treatment or the role of hs-CRP in the prediction of response to depression treatment is still controversial (2,3). To date, no study has examined this association in patients with diabetes. As elevated hs-CRP increases the risk of diabetes complications in diabetes (4), we aimed to explore hs-CRP in patients with diabetes and major depression undergoing depression treatment based on the data of the Diabetes and Depression (DAD) study (5). Participants were randomized to 12 weeks (short-term phase) of diabetes-specific group cognitive behavioral therapy or sertraline treatment and followed up for 15 …