Bernd Kulzer

Take Action to Prevent Diabetes – The IMAGE Toolkit for the Prevention of Type 2 Diabetes in Europe

When we ask people what they value most, health is usually top of the list. While effective care is available for many chronic diseases, the fact remains that for the patient, the tax payer and the whole of society: prevention is better than cure. Diabetes and its complications are a serious threat to the survival and well-being of an increasing number of people. It is predicted that one in ten Europeans aged 20-79 will have developed diabetes by 2030. Once a disease of old age, diabetes is now common among adults of all ages and is beginning to affect adolescents and even children. Diabetes accounts for up to 18 % of total healthcare expenditure in Europe. The good news is that diabetes is preventable. Compelling evidence shows that the onset of diabetes can be prevented or delayed greatly in individuals at high risk (people with impaired glucose regulation). Clinical research has shown a reduction in risk of developing diabetes of over 50 % following relatively modest changes in lifestyle that include adopting a healthy diet, increasing physical activity, and maintaining a healthy body weight. These results have since been reproduced in real-world prevention programmes. Even a delay of a few years in the progression to diabetes is expected to reduce diabetes-related complications, such as heart, kidney and eye disease and, consequently, to reduce the cost to society. A comprehensive approach to diabetes prevention should combine population based primary prevention with programmes targeted at those who are at high risk. This approach should take account of the local circumstances and diversity within modern society (e.g. social inequalities). The challenge goes beyond the healthcare system. We need to encourage collaboration across many different sectors: education providers, non-governmental organisations, the food industry, the media, urban planners and politicians all have a very important role to play. Small changes in lifestyle will bring big changes in health. Through joint efforts, more people will be reached. The time to act is now.

Effects of self-management training in Type 2 diabetes: a randomized, prospective trial.

Aimsu2002 The efficacy of three education programmes for Type 2 diabetic patients was tested in a randomized trial. A didactic‐oriented training programme (treatment A) was compared with a self‐management‐oriented programme delivered in group sessions (treatment B). The latter programme was compared with a more individualized approach (treatment C).

Cognitive Behavioral Therapy Versus Sertraline in Patients With Depression and Poorly Controlled Diabetes: The Diabetes and Depression (DAD) Study: A Randomized Controlled Multicenter Trial.

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 patients were encouraged to use bibliotherapy and sertraline patients received continuous treatment. We analyzed differences for HbA1c (primary outcome) and reduction (HAMD-17) or remission (SCID) of depression from baseline to the 1-year follow-up using ANCOVA or logistic regression analysis. RESULTS After 12 weeks, 45.8% of patients responded to antidepressant treatment and were included in the 1-year study phase. Adjusted HbA1c mean score changes from baseline to the end of the long-term phase (−0.27, 95% CI −0.62 to 0.08) revealed no significant difference between interventions. Depression improved in both groups, with a significant advantage for sertraline (HAMD-17 change: −2.59, 95% CI 1.15–4.04, P < 0.05). CONCLUSIONS Depression improved under CBT and sertraline in patients with diabetes and depression, with a significant advantage for sertraline, but glycemic control remained unchanged. CBT and sertraline as single treatment are insufficient to treat secondary care diabetes patients with depression and poor glycemic control.

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

BackgroundDepression 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/DesignThis 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 depression (diagnosed with the Structured Clinical Interview for DSM-IV, SCID) and hemoglobin A1C >7.5% despite current insulin therapy. During the initial phase, patients received either 50–200xa0mg/d sertraline or 10 CBT sessions aiming at the remission of depression and enhanced adherence to diabetes treatment and coping with diabetes. Both groups received diabetes treatment as usual. After 12xa0weeks of this initial open-label therapy, only the treatment-responders (50% depression symptoms reduction, Hamilton Depression Rating Scale, 17-item version [HAMD]) were included in the subsequent one year study phase and represented the primary analysis population. CBT-responders received no further treatment, while SER-responders obtained a continuous, flexible-dose SER regimen as relapse prevention. Adherence to treatment was analyzed using therapeutic drug monitoring (measurement of sertraline and N-desmethylsertraline concentrations in blood serum) and by counting the numbers of CBT sessions received. Outcome assessments were conducted by trained psychologists blinded to group assignment. Group differences in HbA1c (primary outcome) and depression (HAMD, secondary outcome) between 1-year follow-up and baseline will be analyzed by ANCOVA controlling for baseline values. As primary hypothesis we expect that CBT leads to significantly greater improvement of glycemic control in the one year follow-up in treatment responders of the short term phase.DiscussionThe DAD study is the first randomized controlled trial comparing antidepressants to a psychological treatment in diabetes patients with depression.The study is investigator initiated and was supported by the ‘Förderprogramm Klinische Studien (Clinical Trials)’ and the ‘Competence Network for Diabetes mellitus’ funded by the Federal Ministry of Education and Research (FKZ 01KG0505).Trial registrationCurrent controlled trials ISRCTN89333241.

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).nnParticipants were randomized to 12 weeks (short-term phase) of diabetes-specific group cognitive behavioral therapy or sertraline treatment and followed up for 15 months (long-term phase). hs-CRP was assessed at baseline and at the end of the long-term phase with a latex-enhanced immunoturbidimetric method. Ethics approval and written informed consent were obtained (5). Information on baseline hs-CRP was available in 219 patients (mean age 48.1 ± 12.0 years, 62% female, mean HbA1c 9.25 ± 1.4% [78 ± 16.2 mmol/mol], 51.6% type 2 diabetes, median hs-CRP 0.33 mg/dL [interquartile range 0.10, 0.84]). Depression outcomes included short-term treatment response (≥50% reduction of the Hamilton Depression Rating Scale [HAMD-17] baseline score or HAMD-17 posttreatment score ≤7), remission of depression at the end of the long-term phase (HAMD-17 scores ≤7 and no …

Treatment satisfaction and quality-of-life between type 2 diabetes patients initiating long- vs. intermediate-acting basal insulin therapy in combination with oral hypoglycemic agents – a randomized, prospective, crossover, open clinical trial

BackgroundPharmacological and clinical differences between insulin glargine and NPH insulin may translate into differences in patient reported outcomes, but existing data are equivocal.MethodsIn this 48-week, open-label, randomized, multi-center, crossover phase IV trial, insulin naïve type 2 diabetes patients with blood glucose not at target on oral hypoglycemic agents had basal insulin added to their treatment regimen. A total of 343 patients were randomized to either receive insulin glargine (nu2009=u2009176; sequence A) or neutral protamine Hagedorn (NPH) insulin (nu2009=u2009167; sequence B) in period 1 (weeks 1–24) and vice versa in period 2 (weeks 25–48). The primary objective was to assess patient reported outcomes using a composite Diabetes Related Quality of Life (DRQoL) score based on an unweighted Insulin Treatment Experience Questionnaire (ITEQ) score, a Problem Areas in Diabetes (PAID) questionnaire score, and the mental health score in the Short Form (SF)-12® Health Survey, analyzed by analysis of covariance (ANCOVA).ResultsPatients (mean age 62.3u2009±u20099.0; 39.5xa0% female) had a mean diabetes duration of 9.6u2009±u20095.9xa0years, a mean baseline HbA1c of 8.15u2009±u20090.72xa0%, and a mean fasting blood glucose (FBG) level of 9.37u2009±u20092.19xa0mmol/L. A total of 229 patients were available for primary endpoint evaluation (modified intention to treat population). Combining all data from both periods for each insulin treatment, on a 0–100 scale, the mean DRQoL score was 69.6 (±9.04) with insulin glargine and 70.0 (±9.40) with NPH insulin. Neither an effect of treatment with insulin glargine vs NPH insulin (pu2009=u20090.31) nor a period effect (pu2009=u20090.96), nor a sequence effect (pu2009=u20090.76) was observed using ANCOVA.ConclusionsThe results show that in a patient population with sub-optimal glycemic control at baseline, and a low target achievement rate together with a low rate of hypoglycemia, differences in the patient reported outcomes evaluated in this study were negligible between insulin glargine and NPH insulin.Trial registrationClinicaltrials.gov identifier: NCT00941369

Trajectories of depression in adults with newly diagnosed type 1 diabetes: results from the German Multicenter Diabetes Cohort Study

Aims/hypothesisThere is a paucity of longitudinal data on type 1 diabetes and depression, especially in adults. The present study prospectively analysed trajectories of depressive symptoms in adults during the first 5xa0years of living with type 1 diabetes. We aimed to identify distinct trajectories of depressive symptoms and to examine how they affect diabetes outcome.MethodsWe reanalysed data from a prospective multicentre observational cohort study including 313 adults with newly diagnosed type 1 diabetes. At baseline and in annual postal surveys over 5 consecutive years, we gathered patient characteristics and behavioural and psychosocial data (e.g. Symptom Checklist-90-R [SCL-90-R]). Medical data (e.g. HbA1c levels) was obtained from the treating physicians. We applied growth mixture modelling (GMM) to identify distinct trajectories of depression over time.ResultsFive years after diagnosis, 7.8% (nu2009=u200920) of patients were moderately depressed and 10.2% (nu2009=u200926) were severely depressed. GMM statistics identified three possible models of trajectories (class 1, ‘no depressive symptoms’; class 2, ‘worsening depressive symptoms that improve after 2xa0years’; class 3, ‘worsening depressive symptoms’). Severity of depression symptoms at baseline (subscale of the SCL-90-R questionnaire) significantly predicted membership of classes 2 and 3 vs class 1. After 5xa0years, higher HbA1c values were detected in class 3 patients (meanu2009=u20098.2%, 66xa0mmol/mol) compared with class 1 and class 2 (both: meanu2009=u20097.2%, 55xa0mmol/mol).Conclusions/interpretationWe identified distinct trajectories of depressive symptoms that are also relevant for diabetes outcome. Patients with worsening depressive symptoms over time exhibited poor glycaemic control after the first 5xa0years of living with diabetes. They also exhibited a reduced quality of life and increased diabetes-related distress.

Can trajectories of glycemic control be predicted by depression, anxiety, or diabetes-related distress in a prospective cohort of adults with newly diagnosed type 1 diabetes? Results of a five-year follow-up from the German multicenter diabetes cohort study (GMDC-Study)

AIMSnThe longitudinal association between glycemic control with depression, anxiety or diabetes-related distress in type 1 diabetes is poorly understood. Therefore, we examined long-term trajectories of HbA1c in a new-onset cohort of adults with type 1 diabetes, and analyzed associations with depression, anxiety, and diabetes-related distress.nnnMETHODSnWe included 313 newly diagnosed adults with type 1 diabetes in a prospective multicenter cohort study. Depression, anxiety, and diabetes-related distress were assessed starting with the diabetes diagnosis and at five annual surveys. HbA1c-measurements started with the one-year follow-up. HbA1c trajectories were analyzed applying Growth mixture modeling, while prediction of membership in the trajectories classes was analyzed using multiple regression, and one-way ANOVA/Chi2 to identify differences between classes.nnnRESULTSnAverage HbA1c increased constantly: follow-up at 1-year 6.5% (48u202fmmol/mol), 2-years 6.9% (52u202fmmol/mol), 3-years 7.1% (54u202fmmol/mol), 4-years 7.1% (54u202fmmol/mol), and 5-years 7.4% (57u202fmmol/mol). HbA1c trajectories included one good control and three poor control (52% of patients) classes. At the five-year follow-up, mean HbA1c was 6.3% (45u202fmmol/mol) in the good control class, and ranging from 7.9% (63u202fmmol/mol) to 9.0% (75u202fmmol/mol) in the three poor control classes. Classes were neither predicable, nor differentiated by depression, anxiety, or diabetes-related distress.nnnCONCLUSIONSnWe identified distinct trajectories of glycemic control. Depression and anxiety were highly prevalent but they neither predicted poor/good glycemic control trajectories nor were they associated with glycemic control at any assessment point.

Continuous glucose monitoring: A training programme for all age groups

Optimal usage of continuous glucose monitoring (CGM) requires adequate preparation and training. Patients using a CGM system without special training often do not achieve their intended improvement of metabolic control. Some stop using the system due to disappointing results. For this reason a structured training programme called ‘SPECTRUM’ was developed in Germany to ensure a high-quality standard for the initiation of CGM systems. This programme is suitable for patients of all age groups and is applicable to all CGM systems and all forms of insulin therapy. Structured curricula (adults, parents of young children, adolescents) were developed enabling diabetes centres with less experience to offer comprehensive CGM training. Key requirements of SPECTRUM were (1) independent from manufactures and (2) product-neutrality enabling certification for reimbursement after formal evaluation within the framework of a large clinical trial. SPECTRUM was published in January 2016 in German and translations into other languages are planned.