Bernhard Kulzer

The Diabetes Self-Management Questionnaire (DSMQ): development and evaluation of an instrument to assess diabetes self-care activities associated with glycaemic control.

BackgroundThough several questionnaires on self-care and regimen adherence have been introduced, the evaluations do not always report consistent and substantial correlations with measures of glycaemic control. Small ability to explain variance in HbA1c constitutes a significant limitation of an instrument’s use for scientific purposes as well as clinical practice. In order to assess self-care activities which can predict glycaemic control, the Diabetes Self-Management Questionnaire (DSMQ) was designed.MethodsA 16 item questionnaire to assess self-care activities associated with glycaemic control was developed, based on theoretical considerations and a process of empirical improvements. Four subscales, ‘Glucose Management’ (GM), ‘Dietary Control’ (DC), ‘Physical Activity’ (PA), and ‘Health-Care Use’ (HU), as well as a ‘Sum Scale’ (SS) as a global measure of self-care were derived. To evaluate its psychometric quality, 261 patients with type 1 or 2 diabetes were assessed with the DSMQ and an established analogous scale, the Summary of Diabetes Self-Care Activities Measure (SDSCA). The DSMQ’s item and scale characteristics as well as factorial and convergent validity were analysed, and its convergence with HbA1c was compared to the SDSCA.ResultsThe items showed appropriate characteristics (mean item-total-correlation: 0.46 ± 0.12; mean correlation with HbA1c: -0.23 ± 0.09). Overall internal consistency (Cronbach’s alpha) was good (0.84), consistencies of the subscales were acceptable (GM: 0.77; DC: 0.77; PA: 0.76; HU: 0.60). Principal component analysis indicated a four factor structure and confirmed the designed scale structure. Confirmatory factor analysis indicated appropriate fit of the four factor model. The DSMQ scales showed significant convergent correlations with their parallel SDSCA scales (GM: 0.57; DC: 0.52; PA: 0.58; HU: n/a; SS: 0.57) and HbA1c (GM: -0.39; DC: -0.30; PA: -0.15; HU: -0.22; SS: -0.40). All correlations with HbA1c were significantly stronger than those obtained with the SDSCA.ConclusionsThis study provides preliminary evidence that the DSMQ is a reliable and valid instrument and enables an efficient assessment of self-care behaviours associated with glycaemic control. The questionnaire should be valuable for scientific analyses as well as clinical use in both type 1 and type 2 diabetes patients.

The Effect of a Diabetes-Specific Cognitive Behavioral Treatment Program (DIAMOS) for Patients With Diabetes and Subclinical Depression: Results of a Randomized Controlled Trial

OBJECTIVE Subclinical depression is one of the most frequent mental comorbidities in patients with diabetes and is associated with a poorer long-term prognosis. Since there is a lack of specific intervention concepts for this patient group, a self-management–oriented group program (DIAMOS [Diabetes Motivation Strengthening]) was newly developed and evaluated in a randomized trial. RESEARCH DESIGN AND METHODS DIAMOS is composed of cognitive behavioral interventions aiming at the reduction of diabetes distress. The active control group (CG) received diabetes education. The primary outcome was depressive symptoms. Secondary outcomes were diabetes distress, well-being, self-care behavior, diabetes acceptance, diabetes treatment satisfaction, HbA1c, and subclinical inflammation. RESULTS Two hundred fourteen participants (mean age 43.3 ± 13.3 years, female sex 56.5%, type 2 diabetes 34.1%, mean diabetes duration 14.2 ± 10.5 years, HbA1c 8.9 ± 1.8%, BMI 28.7 ± 71 kg/m2) were randomized. The 12-month follow-up revealed a significantly stronger reduction of depressive symptoms (Center for Epidemiologic Studies Depression Scale score) in the DIAMOS group compared with the CG (Δ3.9 [95% CI 0.6–7.3], P = 0.021). Of the secondary variables, the Patient Health Questionnaire-9 (Δ1.7 [95% CI 0.2–3.2], P = 0.023), Problem Areas in Diabetes scale (Δ8.2 [95% CI 3.1–13.3], P = 0.002), and Diabetes Distress Scale scores (Δ0.3 [95% CI 0.1–0.5], P = 0.012) displayed significant treatment effects. Moreover, the risk of incident major depression in the DIAMOS group was significantly reduced (odds ratio 0.63 [95% CI 0.42–0.96], P = 0.028). Inflammatory variables were not substantially affected. CONCLUSIONS DIAMOS is more effective in lowering depressive symptoms and diabetes-related distress in diabetic patients with subclinical depression. DIAMOS also has a preventive effect with respect to the incidence of major depression.

The effect of a diabetes education programme (PRIMAS) for people with type 1 diabetes: Results of a randomized trial

OBJECTIVEnIn a randomized, multi-centre trial, the efficacy of a self-management-oriented education programme (PRIMAS) for people with type 1 diabetes was compared with an established education programme as control group (CG). Primary outcome was the effect on glycaemic control in a 6-month follow-up. Secondary outcomes were the impact on emotional aspects, self-management related aspects and hypoglycaemia problems.nnnMETHODSnThe study was conducted in an outpatient setting. 160 participants were randomized. Baseline characteristics in PRIMAS and CG were similar (age 45.1±13.5 vs. 45.9±13.1 years, p=.716; diabetes duration 18.8±12.3 vs. 19.8±13.4 years, p=.615; BMI 26.5±4.6 vs. 27.5±5.0kg/m(2), p=.236; HbA1c 8.3±1.1 vs. 8.1±1.0%, p=.236).nnnRESULTSnAt follow-up there was a significant 0.4 percentage points greater reduction of HbA1c in PRIMAS compared to CG (Δ -0.4±1.0% vs. Δ 0.0±0.6%; p=.012). Also, diabetes-related distress (Δ -0.3±0.7 vs. -0.1±0.4, p=.032) and dissatisfaction with diabetes treatment (Δ -3.3±6.9 vs. -1.9±5.6, p=.024) decreased more in PRIMAS. Diabetes empowerment (Δ 2.6±5.9 vs. 0.8±5.1, p=.037) and diabetes self-efficacy (Δ 1.4±3.6 vs. 0.2±4.0, p=.013) increased in PRIMAS. Incidence of severe hypoglycemia, hypoglycemia awareness, diabetes knowledge, and self-care behaviour improved in both groups with no significant differences between groups.nnnCONCLUSIONnPRIMAS is more effective in lowering HbA1c than a previously established education programmes and also showed superiority in reducing diabetes-related distress and increasing diabetes empowerment, diabetes self-efficacy and satisfaction with insulin therapy.

Diabetes as a case study of chronic disease management with a personalized approach: The role of a structured feedback loop

As non-communicable or chronic diseases are a growing threat to human health and economic growth, political stakeholders are aiming to identify options for improved response to the challenges of prevention and management of non-communicable diseases. This paper is intended to contribute ideas on personalized chronic disease management which are based on experience with one major chronic disease, namely diabetes mellitus. Diabetes provides a pertinent case of chronic disease management with a particular focus on patient self-management. Despite advances in diabetes therapy, many people with diabetes still fail to achieve treatment targets thus remaining at risk of complications. Personalizing the management of diabetes according to the patients individual profile can help in improving therapy adherence and treatment outcomes. This paper suggests using a six-step cycle for personalized diabetes (self-)management and collaborative use of structured blood glucose data. E-health solutions can be used to improve process efficiencies and allow remote access. Decision support tools and algorithms can help doctors in making therapeutic decisions based on individual patient profiles. Available evidence about the effectiveness of the cycles constituting elements justifies expectations that the diabetes management cycle as a whole can generate medical and economic benefit.

Negative association between depression and diabetes control only when accompanied by diabetes-specific distress.

Evidence of the negative impact of depression on glycaemic control is equivocal, and diabetes-related distress has been proposed as potential mediator. 466 diabetes patients were cross-sectionally assessed for depression (Center for Epidemiologic Studies Depression Scale), diabetes-related distress (Diabetes Distress Scale), and glycaemic control (HbA1c). We distinguished the associations of depression and diabetes distress with glycaemic control using analysis of variance and multiple regression. Neither patients with depression only nor diabetes distress only differed significantly from controls regarding HbA1c. However, HbA1c was substantially increased when both conditions were present (9.2 vs. 8.6xa0%, Pxa0=xa00.01). As in previous studies, we observed a significant association between depression and hyperglycaemia (Pxa0<xa00.01). However, axa0mediation analysis revealed that this association in fact depended on the presence of diabetes distress (Pxa0<xa00.01). Depression seems to be associated with hyperglycaemia particularly when accompanied by diabetes distress, suggesting that adjusting clinical procedures regarding diabetes distress may facilitate the identification and care of high-risk patients.

Depression is linked to hyperglycaemia via suboptimal diabetes self-management: A cross-sectional mediation analysis

OBJECTIVEnTo analyse if the association between depressive symptoms and hyperglycaemia is mediated by diabetes self-management.nnnMETHODSn430 people with diabetes (57.7% type 1, 42.3% type 2) were cross-sectionally assessed using validated self-report scales for depressive symptoms (Center for Epidemiologic Studies Depression Scale (CES-D)) and diabetes self-management (Diabetes Self-Management Questionnaire (DSMQ)); HbA1c was analysed simultaneously in a central laboratory. Structural equation modelling was used to test if the association between depressive symptoms and hyperglycaemia (HbA1c) was mediated by suboptimal self-management in people with type 1 and type 2 diabetes.nnnRESULTSnThe hypothesised model of depressive symptoms, diabetes self-management and hyperglycaemia fit the data well for both diabetes types (SRMR≤0.04, TLI≥0.99, CFI>0.99, RMSEA≤0.02 for both models). In both the type 1 and type 2 diabetes group, higher depressive symptoms were associated with lower self-management (P<0.001) and lower self-management was associated with higher HbA1c (P<0.001). Results indicated that the association between depressive symptoms and hyperglycaemia was significantly mediated by suboptimal diabetes self-management in both type 1 and type 2 diabetes patients (P<0.001). Significant direct associations between depressive symptoms and hyperglycaemia, not mediated by self-management, could not be observed.nnnCONCLUSIONSnThis study provides good evidence supporting that depression is linked to hyperglycaemia via suboptimal diabetes self-management in both major diabetes types.

Integrated Personalized Diabetes Management (PDM): Design of the ProValue Studies: Prospective, Cluster-Randomized, Controlled, Intervention Trials for Evaluation of the Effectiveness and Benefit of PDM in Patients With Insulin-Treated Type 2 Diabetes

Background: Collaborative use of structured self-monitoring of blood glucose (SMBG) data and data management software, utilized within a 6-step cycle enables integrated Personalized Diabetes Management (PDM). The 2 PDM-ProValue studies shall assess the effectiveness of this approach in improving patient outcomes and practice efficiencies in outpatient settings. Methods: The PDM-ProValue studies are 12-month, prospective, cluster-randomized, multicenter, trials to determine if use of integrated PDM in daily life improves glycemic control in insulin-treated type 2 diabetes patients. Fifty-four general medical practices (GPs) and 36 diabetes-specialized practices (DSPs) across Germany will be recruited. The practices will be randomly assigned to the control groups (CNL) or the intervention groups (INT) via cluster-randomization. CNL practices will continue with their usual care; INT practices will utilize integrated PDM. The sample size is 1,014 patients (n = 540 DSP patients, n = 474 GP patients). Each study is designed to detect a between-group difference in HbA1c change of at least 0.4% at 12 months with a power of 90% and 2-sided significance level of .05. Differences in timing and degree of treatment adaptions, treatment decisions, blood glucose target ranges, hypoglycemia, self-management behaviors, quality of life, patients attitudes, clinician satisfaction, practice processes, and resource consumption will be assessed. Study endpoints will be analyzed for the modified intent-to-treat and per protocol populations. Trial results are expected to be available in late 2016. Discussion: Effective and efficient strategies to optimize diabetes management are needed. These randomized studies will help determine if PDM is beneficial.

Assessing Diabetes Self-Management with the Diabetes Self-Management Questionnaire (DSMQ) Can Help Analyse Behavioural Problems Related to Reduced Glycaemic Control

Aim To appraise the Diabetes Self-Management Questionnaire (DSMQ)’s measurement of diabetes self-management as a statistical predictor of glycaemic control relative to the widely used SDSCA. Methods 248 patients with type 1 diabetes and 182 patients with type 2 diabetes were cross-sectionally assessed using the two self-report measures of diabetes self-management DSMQ and SDSCA; the scales were used as competing predictors of HbA1c. We developed a structural equation model of self-management as measured by the DSMQ and analysed the amount of variation explained in HbA1c; an analogue model was developed for the SDSCA. Results The structural equation models of self-management and glycaemic control showed very good fit to the data. The DSMQ’s measurement of self-management showed associations with HbA1c of –0.53 for type 1 and –0.46 for type 2 diabetes (both P < 0.001), explaining 21% and 28% of variation in glycaemic control, respectively. The SDSCA’s measurement showed associations with HbA1c of –0.14 (P = 0.030) for type 1 and –0.31 (P = 0.003) for type 2 diabetes, explaining 2% and 10% of glycaemic variation. Predictive power for glycaemic control was significantly higher for the DSMQ (P < 0.001). Conclusions This study supports the DSMQ as the preferred tool when analysing self-reported behavioural problems related to reduced glycaemic control. The scale may be useful for clinical assessments of patients with suboptimal diabetes outcomes or research on factors affecting associations between self-management behaviours and glycaemic control.

Association between pro- and anti-inflammatory cytokines and depressive symptoms in patients with diabetes—potential differences by diabetes type and depression scores

Subclinical inflammation has been implicated in the development of depression, a common comorbidity of type 1 diabetes (T1D) and type 2 diabetes (T2D). This study aimed to characterise the relationships between biomarkers of inflammation and depressive symptoms in T1D and T2D. Biomarkers of inflammation were measured in serum of participants with elevated depressive symptoms and T1D (nu2009=u2009389, mean age 38 years, diabetes duration 15u2009±u200911 years) or T2D (nu2009=u2009204, mean age 56 years, diabetes duration 13u2009±u20098 years). Subclinical depression was examined using three questionnaires (Center for Epidemiologic Studies Depression [CES-D], Patient Health Questionnaire-9 [PHQ-9], 5-item World Health Organization Well-Being Index [WHO-5]). In T1D, levels of interleukin-1 receptor antagonist (IL-1RA) were positively associated with two depression scores (CES-D, PHQ-9), and high-sensitivity C-reactive protein (hsCRP) was positively associated with depression for one score (WHO-5) after adjustment for age, sex, body mass index, diabetes duration, metabolic variables, medication and comorbidities (Pu2009=u20090.008-0.042). In T2D, IL-18 and IL-1RA were positively associated with depression for two scores (IL-18: PHQ-9, WHO-5; IL-1RA: CES-D, WHO-5), hsCRP was associated with one depression score (PHQ-9), and adiponectin showed an inverse association with one depression score (PHQ-9) after adjustment (Pu2009=u20090.006–0.048). No associations were found for IL-6 and CC-chemokine ligand 2 (CCL2). In conclusion, we observed associations between hsCRP, IL-1RA and depressive symptoms in patients with diabetes. In T2D, there was additional evidence for associations of IL-18 and (inversely) adiponectin with depressive symptoms. The strength of the associations appeared to depend on diabetes type and the method used to asssess depressive symptoms.

Comparison of the Efficacy of a Diabetes Education Programme for Type 1 Diabetes (PRIMAS) in a Randomised Controlled Trial Setting and the Effectiveness in a Routine Care Setting: Results of a Comparative Effectiveness Study.

Background The effectiveness of an intervention in clinical practice is often reduced compared to the efficacy demonstrated in a randomised controlled trial (RCT). In this comparative effectiveness study, the RCT-proven efficacy of a diabetes education programme for type 1 diabetic patients (PRIMAS) was compared to the effectiveness observed in an implementation trial (IT) under routine care conditions. Methods 75 patients with type 1 diabetes received PRIMAS through an RCT, whereas 179 patients were observed in an implementation trial. Baseline characteristics and treatment outcomes at the 6-month follow-up (improvement of HbA1c, hypoglycaemia problems, and diabetes-related distress) were compared. Results At baseline, the type 1 diabetic patients in the RCT had a significant longer diabetes duration (18.7±12.3 vs. 13.8±12.7 yrs., p = .005), lower self-efficacy scores (21.9±4.7 vs. 23.7±6.1, p = .02) and a greater number of diabetes complications (0.8±1.3 vs. 0.4±0.9, p = .02). After 6 months, PRIMAS achieved comparable effects under RCT and implementation trial conditions, as demonstrated by improvement in HbA1c (-0.36%±1.1 vs. -0.37±1.2; Δ -0.01, 95% CI -0.33 to 0.31) and hypoglycaemia unawareness (-0.5±1.4 vs. -0.3±1.4; Δ 0.18, 95% CI -0.21 to 0.57). The likelihood of clinical improvement did not depend on the trial setting (RCT vs. IT: OR 1.18, 95% CI 0.60 to 2.33). The participants with worse glycaemic control (OR 1.40, 95% CI 1.02 to 1.92), hypoglycaemia problems (OR 2.13, 95% CI 1.53 to 2.97) or elevated diabetes distress (OR 1.40, 95% CI 1.03 to 1.89) had a better chance of clinical improvement. Conclusions The effectiveness of PRIMAS under routine care conditions was comparable to the efficacy demonstrated in the RCT. Clinical improvement was independent of the setting in which PRIMAS was evaluated. The PRIMAS education programme for type 1 diabetes can be delivered under conditions of routine care without a loss of effectiveness, compared to its original evaluation in an RCT.