Background: The InsuPad is a medical device to accelerate insulin resorption by applying local heat at the insulin injection site. This crossover study examined the impact of the InsuPad use on postprandial glucose excursions under daily life conditions.
Methods: In 1 study phase, diabetic patients used the InsuPad when injecting bolus insulin before breakfast and dinner and measured their blood glucose 5 times daily (before breakfast, lunch, and dinner and after breakfast and dinner). In the other study phase, blood glucose measurements were maintained without using the InsuPad. The order of the study phases was randomized.
Results: Twenty patients with a high insulin demand took part (30% type 1 diabetes, age 53.7 ± 8.9 years, diabetes duration 14.9 ± 7.4 years; HbA1c 8.3 ± 0.8%; total daily insulin demand 0.97 ± 0.32 IU per kg). Postprandial glucose excursion was reduced by 15.4 mg/dl (95% CI 9.7-21.2 mg/dl; P = .011) after breakfast and dinner if InsuPad was used. The mean blood glucose was lower by 8.8 mg/dl (95% CI 0:3-18:0 mg/dl; P = .099) when using the InsuPad. Safety parameters and the percentage of hypoglycemic (< 60 mg/dl) or hyperglycemic (> 300 mg/dl) blood glucose measurements were not negatively affected by InsuPad use (hypoglycemic values 1.4% vs 1.5%, P = .961; hyperglycemic values 2.6% vs 4.0%, P = .098).
Conclusions: Local heating of the insulin injection site by use of the InsuPad device is an effective and safe method to reduce postprandial blood glucose excursions under daily life conditions without negative side effects on the occurrence of low or high blood glucose values.
Charcot neuro-osteoarthropathy (CN) is a rare complication of diabetic foot syndrome associated with chronic inflammation of the foot and severe, limb-threatening musculoskeletal deformities. Aim of this study was to investigate patients with CN for comorbidities, amputations, ulcers, secondary diseases and mortality.
The study was conducted at a specialized German hospital for patients with diabetes. One-hundred and eleven patients were enrolled, and their course was followed over a period of 15 years. Association of CN with comorbidity, foot ulcers, amputations and mortality was assessed. Clinical course of patients was followed using two standardized questionnaires.
Presence of CN was significantly associated with diabetic retinopathy (p = 0.047), plantar (p < 0.001), tarsal (p = 0.032) and middle-foot ulcers (p = 0.01). A significant correlation between the presence of CN and a history of amputations was seen (p = 0.022). Patients were at increased risk to suffer from subsequent amputations during follow-up when micro- and macrovascular comorbidities such as retinopathy (p = 0.01) and peripheral artery disease (p < 0.001) were present. Additionally, coronary artery disease (CHD) was identified as an independent predictor of mortality in the cohort of this study (OR 6.192, 95 % CI 1.155–33.208, p = 0.033). Median overall survival of patients with CN and CHD was significantly shorter than OS of patients without CHD (7.8 vs. 13.1 years, p = 0.0045, HR 2.8437, 95 % CI 0.9818–8.2364).
In our study, CHD was the most important factor of survival in CN patients. For optimal management of CN, adequate diagnostics and treatment of CHD according to current guidelines should be considered.
Reliability of blood glucose (BG) measurements is a prerequisite for successful diabetes management. Publications on the evaluation of self-monitored glucose values, however, are frequently characterized by a confusion in terminology. We provide an inventory of key terms such as accuracy, trueness, precision, traceability, calibration, and matrix effect to avoid future misunderstanding. Definitions are taken from the metrological literature and international norms and explained in a language intended for nonspecialists in metrology. The terms are presented in light of the need to apply generally accepted definitions. In addition, a description of requirements and components for a sound evaluation of BG measurement systems is presented. These factors will also enable improvement in future comparisons of study results.
Though 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.
A 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.
The 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.
This 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.
Overeating, weight gain and obesity are considered as a major health problem in Western societies. At present, an impairment of response inhibition and a biased salience attribution to food-associated stimuli are considered as important factors associated with weight gain. However, recent findings suggest that the association between an impaired response inhibition and salience attribution and weight gain might be modulated by other factors. Thus, hunger might cause food-associated cues to be perceived as more salient and rewarding and might be associated with an impairment of response inhibition. However, at present, little is known how hunger interacts with these processes. Thus, the aim of the present study was to investigate whether hunger modulates response inhibition and attention allocation towards food-associated stimuli in normal-weight controls. A go-/nogo task with food-associated and control words and a visual dot-probe task with food-associated and control pictures were administered to 48 normal-weight participants (mean age 24.5 years, range 19–40; mean BMI 21.6, range 18.5–25.4). Hunger was assessed twofold using a self-reported measure of hunger and a measurement of the blood glucose level. Our results indicated that self-reported hunger affected behavioral response inhibition in the go-/nogo task. Thus, hungry participants committed significantly more commission errors when food-associated stimuli served as distractors compared to when control stimuli were the distractors. This effect was not observed in sated participants. In addition, we found that self-reported hunger was associated with a lower number of omission errors in response to food-associated stimuli indicating a higher salience of these stimuli. Low blood glucose level was not associated with an impairment of response inhibition. However, our results indicated that the blood glucose level was associated with an attentional bias towards food-associated cues in the visual dot probe task. In conclusion our results suggest that hunger induces an approach bias and is associated with an impairment of response inhibition when normal-weight participants are confronted with food-associated cues. These findings are important as these processes play a crucial role with regard to the control of food-intake and weight gain and are assumed to contribute to obesity. Thus, individualized treatment approaches taking into account the experience of hunger in everyday-life situations should be considered in addition to a training of response inhibition.
Cognitive behavioural models consider certain personality traits to be risk factors for the development of Body Dysmorphic Disorder (BDD). Research on personality traits in BDD is scarce, therefore this study examined perfectionism, aesthetic sensitivity and the behavioural inhibition system (BIS) in BDD. Furthermore, the association between these personality traits and the extent of dysmorphic concerns was investigated.
Individuals with BDD (n=58) and a population based control sample (n=2071), selected from a representative German population survey, completed self-report questionnaires assessing DSM-5 criteria of BDD, dysmorphic concerns, perfectionism, aesthetic sensitivity and BIS-reactivity.
Individuals with BDD reported significantly higher degrees of perfectionism as well as of BIS-reactivity compared to the population based control sample, whereas the groups did not differ significantly regarding aesthetic sensitivity. However, for the total sample, each of the personality traits was related dimensionally to dysmorphic concerns.
Current BDD models consider perfectionism and aesthetic sensitivity to be vulnerability factors. In addition to these concepts, the present study suggests that BIS-reactivity is related to BDD. Self-reported aesthetic sensitivity was not found to be specifically pronounced in BDD, but along with perfectionism and BIS-reactivity aesthetic sensitivity was generally associated with dysmorphic concerns.
Research on the prevalence of body dysmorphic disorder (BDD) in individuals with eating disorders (EDs) is scarce. Nonweight-related appearance concerns, which can be considered as variants of BDD concerns, have also rarely been examined in EDs. This study therefore investigates BDD prevalence and nonweight-related appearance concerns in EDs.
One hundred individuals with EDs (49 inpatients with anorexia nervosa, 51 inpatients with bulimia nervosa) completed structured diagnostic interviews and self-report questionnaires.
Twelve individuals with EDs (12.0%) suffered from comorbid BDD, with their body dysmorphic concerns being unrelated to weight and shape. BDD lifetime-prevalence was 15.0%. There was a high prevalence of dissatisfaction with nonweight-related body features such as skin, hair, teeth, nose, and height (20.8 to 53.5%).
Findings indicate that BDD is a frequent comorbid disorder in individuals with EDs. Furthermore, along with weight and body shape, nonweight-related appearance concerns are also common in individuals with EDs.
In DSM-5 the diagnosis of body dysmorphic disorder (BDD) has been subjected to two important changes: Firstly, BDD has been assigned to the category of obsessive–compulsive and related disorders. Secondly, a new criterion has been defined requiring the presence of repetitive behaviors or mental acts in response to appearance concerns. The aims of this study were to report the prevalence rates of BDD based on a DSM-5 diagnosis, and to evaluate the impact of the recently introduced DSM-5 criteria for BDD by comparing the prevalence rates (DSM-5 vs. DSM-IV).
BDD-criteria (DSM-IV/DSM-5), dysmorphic concerns, and depressive symptoms, were assessed in a representative sample of the German general population (N = 2129, aged 18–65 years).
The association between BDD case identification based on DSM-IV and DSM-5 was strong (Phi = .95, p < .001), although point prevalence of BDD according to DSM-5 was slightly lower (2.9%, n = 62 vs. 3.2%, n = 68). Approximately one third of the identified BDD (DSM-5) cases reported time-consuming behavioral acts in response to appearance concerns. In detail, 0.8% of the German general population fulfilled the BDD criteria and reported repetitive acts of at least one hour/day.
The revised criteria of BDD in DSM-5 do not seem to have an impact on prevalence rates. However, the recently added B-criterion reflects more precisely the clinical symptoms of BDD, and may be useful for distinguishing between various severity levels related to repetitive behaviors/mental acts.
Hypoglycaemia is a common side effect of insulin therapy in diabetes patients, with negative physical and emotional impacts. Despite this, there are few studies investigating the frequency of non-severe hypoglycaemic events from the perspective of patients in the real-world setting. We investigated self-reported NSHE frequency and levels of hypoglycaemia awareness in Germany.
Respondents>15 years with Type 1 or insulin-treated Type 2 diabetes (receiving basal only, basal-bolus or other insulin regimens) were recruited using online panels to complete≤4 questionnaires. Questionnaires collected demographics, non-severe hypoglycaemic event rates and patient-reported level of hypoglycaemia awareness. Non-severe hypoglycaemic event rates are reported as respondent-week records and calculated using data from all respondents completing at least one questionnaire.
A total of 1 771 respondent-week records were obtained from 614 participants. Mean non-severe hypoglycaemic event rates per respondent-week were 1.6 for Type 1 and 0.6–0.8 for Type 2, with estimated annual rates of 83 and 31–42 respectively. Two-thirds of Type 1 (65%) and Type 2 (61–72%) respondents reported impaired levels of awareness or unawareness of hypoglycaemic events (inability or impaired ability to recognise the symptoms of hypoglycaemia). Respondents’ self-reported hypoglycaemia-awareness was significantly associated with the proportion of asymptomatic non-severe hypoglycaemic events; respondents classified as being unaware of hypoglycaemia had a higher proportion of asymptomatic non-severe hypoglycaemic events than aware respondents.
Non-severe hypoglycaemic events are common in people with Type 1 or insulin-treated Type 2 diabetes in the real-world setting in Germany but may still be underestimated due to an inability to recognise the symptoms of hypoglycaemia.