Previous research demonstrated that the exposure to media portrayals of the thin body ideal negatively affects body satisfaction and mood of healthy women and thus represents a sociocultural risk factor for the development of eating disorders. However, at present, it is not known whether negative effects of the thin ideal are pronounced in eating-disordered patients.
Female inpatients with a current diagnosis of anorexia nervosa (N = 36), bulimia nervosa (N = 32), or mood or anxiety disorder (N = 31), and women with no current psychiatric diagnosis were randomly assigned to exposure to magazine pictures depicting the thin female body ideal or landscape scenes in two experimental phases (leafing through a magazine followed by instructed imagination of a picture from the magazine). The groups were compared on measures of body satisfaction and mood that were collected before and after the two phases.
Leafing through a fashion magazine was not associated with negative effects on body satisfaction or mood in all groups. Imagining the thin ideal resulted in a decrease in body satisfaction and a decrease in positive mood. We found no diagnosis-specific effects indicating no stronger negative impact of the thin ideal on eating-disorder patients.
Given the lacking differences between eating-disordered patients and controls, these findings underline the importance of future research to enhance our understanding of what happens when patients are exposed to external or internal stimuli of media images of the thin ideal.
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 selfmanagement–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.
Two hundred fourteen participants (mean age 43.3 6 13.3 years, female sex 56.5%, type 2 diabetes 34.1%, mean diabetes duration 14.2 6 10.5 years, HbA1c 8.9 6 1.8%, BMI 28.7 6 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 (D3.9 [95% CI 0.6–7.3], P = 0.021). Of the secondary variables, the Patient Health Questionnaire-9 (D1.7 [95% CI 0.2–3.2], P = 0.023), Problem Areas in Diabetes scale (D8.2 [95% CI 3.1–13.3], P = 0.002), and Diabetes Distress Scale scores (D0.3 [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.
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 PaQ® insulin delivery system is a simple-to-use patch-on device that provides preset basal rates and bolus insulin on demand. In addition to feasibility of use, safety, and efficacy (reported elsewhere), this study analyzed the impact of PaQ on patient-reported outcomes, including barriers to insulin treatment, diabetes-related distress, and attitudes toward insulin therapy in patients with type 2 diabetes on a stable multiple daily injection (MDI) regimen. This single-center, openlabel, single-arm study comprised three 2-week periods: baseline (MDI), transition from MDI to PaQ, and PaQ treatment. Validated questionnaires were administered during the baseline and PaQ treatment periods: Barriers to Insulin Treatment questionnaire (BIT), Insulin Treatment Appraisal Scale (ITAS), and Problem Areas in Diabetes scale (PAID). Eighteen patients (age 59 ± 5 years, diabetes duration 15 ± 7 years, 21% female, HbA1c 7.7 ± 0.7%) completed the questionnaires. There was a strong, significant effect of PaQ use in mean BIT total scores (difference [D] = −5.4 ± 0.7.7, P = .01, effect size [d] = 0.70). Patients perceived less stigmatization by insulin injection (D = −2.2 ± 6.2, P = .18, d = 0.35), increased positive outcome (D = 1.9 ± 6.6, P = .17, d = 0.29), and less fear of injections (1.3 ± 4.8, P = .55, d = 0.28). Mean change in ITAS scores after PaQ device use showed a nonsignificant improvement of 1.71 ± 5.63 but moderate effect size (d = 0.30, P = .14). No increase in PAID scores was seen. The results and moderate to large effects sizes suggest that PaQ device use has beneficial and clinically relevant effects to overcoming barriers to and negative appraisal of insulin treatment, without increasing other diabetesrelated distress.
Background: Pharmacological and clinical differences between insulin glargine and NPH insulin may translate into differences in patient reported outcomes, but existing data are equivocal.
Methods: In 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 (n = 176; sequence A) or neutral protamine Hagedorn (NPH) insulin (n = 167; 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).
Results: Patients (mean age 62.3 ± 9.0; 39.5 % female) had a mean diabetes duration of 9.6 ± 5.9 years, a mean baseline HbA1c of 8.15 ± 0.72 %, and a mean fasting blood glucose (FBG) level of 9.37 ± 2.19 mmol/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 (p = 0.31) nor a period effect (p = 0.96), nor a sequence effect (p = 0.76) was observed using ANCOVA.
Conclusions: The 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 registration: Clinicaltrials.gov identifier: NCT00941369
Systems for continuous glucose monitoring (CGM) have been available for a number of years, and numerous clinical studies have been performed with them. Interestingly, in many of these studies patients with an increased risk of hypoglycemic events were excluded. In addition, in most studies subjects were using a pump for insulin delivery. Therefore our knowledge about the benefit of CGM in patients employing multiple daily injections (MDI) of insulin is limited, especially when it comes to a reduction in the risk of low glucose events in high-risk individuals. We are planning to run a 26-week randomized controlled study in Germany (HypoDE, Hypoglycemia in Deutschland) that is focused on evaluating if such a reduction can be observed in patients on MDI with an increased risk of low glucose events. In all, 160 patients will participate in the study, randomized into the intervention group and control group. Ideally one would study if the frequency of severe hypoglycemic events is different between both groups. However, this would require such a large sample size and study duration, so for pragmatic reasons we will use low glucose levels <55 mg/dl (measured by CGM) for at least 20 minutes as a risk marker for severe hypoglycemic events. The results from the HypoDE study shall help determine the advantage of using CGM in subjects with type 1 diabetes with an increased risk of low glucose events treated with MDI.
To investigate the longitudinal bi-directionality of diabetes-related distress and depressive symptoms.
A total of 509 patients receiving intensified insulin therapy completed the Centre for Epidemiological Studies Depression scale questionnaire for the assessment of depressive symptoms as well as the Problem Areas in Diabetes questionnaire for the assessment of diabetes-related distress at baseline and at 6-month follow-up. Separate logistic and linear regression analyses for incidence and persistence were performed with demographic (age, gender, BMI) and medical (diabetes type, HbA1c, diabetes duration, late complications) control variables.
Diabetes-related distress at baseline increased the risk of the incidence of elevated depressive symptoms by 2.56-fold (odds ratio 2.56; 95% CI 1.15–5.72; P = 0.02) when controlling for demographic and medical variables. In addition, diabetes-related distress at baseline doubled the chance of the persistence of elevated depressive symptoms (odds ratio 2.04, 95% CI 1.04–3.99; P = 0.04) when controlling for demographic and medical variables. The chance of having persistent elevated diabetes-related distress was increased 5.94-fold (odds ratio 5.94, 95% CI 2.60–13.59; P < 0.0001) when elevated depressive symptoms were present at baseline. None of the medical variables had an influence on incidence or persistence.
Diabetes-related distress was identified as a risk factor for the incidence and persistence of depressive symptoms. Reducing diabetes-related distress could help to prevent the development of elevated depressive symptoms. Furthermore, depressive symptoms were identified as an amplifier for diabetes-related distress. Diabetes-related distress and depressive symptoms were independent risk factors for each other and should be monitored in routine care to disentangle their influence.
Aims: To study the frequency and intensity of depressive symptoms and associations with physician resource utilisation following insulin initiation in patients with type 2 diabetes mellitus.
Methods: SOLVE was a 24-week observational study. In this sub-analysis of data from Poland, depressive symptoms were evaluated using the Patient Health Questionnaire (PHQ)-9.
Results: PHQ-9 was completed by 942 of 1169 patients (80.6%) at baseline, and 751 (64.2%) at both baseline and final (24-week) visit. PHQ-9 scores indicated depressive symptoms in 45.6% (n = 430) at baseline, and 27.2% (n = 223) at final visit. Mean PHQ-9 change was −2.38 [95% CI −2.73, −2.02], p < 0.001. Depressive symptoms at baseline (OR 6.32, p < 0.001), microvascular disease (OR 2.45, p = 0.016), number of physician contacts (OR 1.16, p = 0.009), and change in HbA1c (OR 0.60, p = 0.025) were independently associated with moderate/severe depressive symptoms at final visit. Patients with more severe depressive symptoms spent more time training to self-inject (p = 0.0016), self-adjust (p = 0.0023) and manage other aspects of insulin delivery (p < 0.0001). Patients with persistent depressive symptoms had more telephone contacts and dose changes at final visit than those without (both p < 0.05).
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.