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

BACKGROUND: 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 HbA(1c) 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. METHODS: 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 HbA(1c) was compared to the SDSCA. RESULTS: The items showed appropriate characteristics (mean item-total-correlation: 0.46 ± 0.12; mean correlation with HbA(1c): -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 HbA(1c) (GM: -0.39; DC: -0.30; PA: -0.15; HU: -0.22; SS: -0.40). All correlations with HbA(1c) were significantly stronger than those obtained with the SDSCA. CONCLUSIONS: 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

Local heating at the insulin injection site by the use of the InsuPad is able to reduce post-prandial glucose excursion in daily life

Background and aims: The insulin action profiles of subcutaneously injected short acting insulin analogues are still slow compared to physiologically released human insulin. Thus, postprandial glucose excursions cannot be avoided. InsuPad is a medical device designed to accelerate insulin delivery rate by applying local heat at the insulin injection site. Whenever an insulin injection is given, the skin surface temperature is heated up locally to 38.5 C° for 30 minutes. This pilot-study examines the impact of the InsuPad use on postprandial glucose excursions after breakfast and dinner in daily life conditions. Materials and methods: Insulin resistant diabetic patients were instructed to use the InsuPad when injecting bolus insulin prior to breakfast and dinner for one month and to measure their blood glucose at least five times per day (pre- and post-breakfast, pre-lunch and pre- and post-dinner). In the other study phase patients were instructed to maintain the same blood glucose measurement schedule for one month, without using the InsuPad. The order of the study phases was randomized. All blood glucose data were transmitted to a central computer using the DIASEND System. A valid pre-post-prandial measurement time difference was 75 - 135 minutes. An ANOVA, controlling for order of study phase, patient and meal (breakfast vs. dinner) was used to analyze the effect of the InsuPad on postprandial glucose excursions. In this study 10 diabetic patients took part (30% type 1 diabetes, age: 51.5 ±7.7 yrs., diabetes duration: 15.7 ± 7.7 yrs.; HbA1c: 8.2 ± 0.9%; bolus insulin dose: 51.7 ± 22.2 insulin units per day; total insulin dose 0.92 insulin units per kg). Results: Preprandial blood glucose levels were similar in the phase with (151.7 ±46.8 mg/dl) and without the InsuPad (148.5 ±38.6 mg/dl, p=.385). Postprandial glucose decreased by 0.05 ± 59.1 mg/dl, if InsuPad was used, whereas the postprandial glucose levels increased by 11.3 ± 56.3 mg/dl if the InsuPad was not used (p=.011). The number (283 vs. 257) and proportion of valid measurements (65.5% vs. 64.4%, p=.740) in the phase with and without InsuPad were highly comparable. The time differences between pre- and post-prandial glucose measurements were very similar in both study phases (102.7 ± 19.0 vs. 102.3 ± 15.6 minutes with and without InsuPad, p=.777). The overall glycaemic control (mean total blood glucose values) was significantly lower when using the InsuPad compared to the no-use-phase (149.7 ± 54.5 mg/dl vs. 158.7 ±57.7 mg/dl; p=.016). The percentage of hypoglycaemic (< 60 mg/dl) or hyperglycaemic values (> 300 mg/dl) was slightly decreased when using the InsuPad, but the difference was not statistically significant (% hypoglycaemic values 1.5% vs. 1.8%, p=.496; % hyperglycaemic values 1.6% vs. 2.1%, p=.250). Conclusion: This pilot-study indicates that local heating of the insulin injection site in insulin resistant diabetic patients by using the InsuPad is able to reduce post-prandial blood glucose excursions as well as mean daily glucose values significantly in daily life conditions. Safety parameters like the prevalence of hypoglycaemic and hyperglycaemic glucose measurements were not affected by the use of InsuPad

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

Einflussfaktoren auf die gesundheitsbezogene Lebensqualität bei Menschen mit Typ-2-Diabetes

Fragestellung: In dieser Studie wurde untersucht, inwieweit sich Typ-2-Diabetespatienten mit intensivierter (ICT) und nicht-intensivierter Insulintherapie (NIT) hinsichtlich ihrer gesundheitsbezogenen Lebensqualität unterscheiden und welche Faktoren diese beeinflussen. Methodik: Lebensqualität wurde mittels EQ-5D erfasst. Neben univariaten Analysen wurde eine multivariate Regressionsanalyse durchgeführt. Abhängige Variable war die Lebensqualität, unabhängige Variablen waren demographische und diabetesspezifische Parameter. Ergebnisse: Beide Gruppen (N = 356; 52% NIT vs. 48% ICT) wiesen die gleiche Alters- und Geschlechterverteilung (62,8 ± 8,2 Jahre; 45% weiblich) auf. ICT-Patienten zeigten eine signifikant längere Diabetesdauer 11,6 ± 6,9 vs. 13,7 ± 7,6 Jahre (p = 0,005) und Dauer der Insulintherapie 2,7 ± 4,1 vs. 5,4 ± 5,0 Jahre (p = 0,001), höheren BMI 31,5 ± 5,2 vs. 33,3 ± 5,9 kg/m2 (p = 0,003), häufigere BZSK/Tag 2,25 ± 1,49 vs. 3,33 ± 1,37 (p = 0,001) und Insulininjektionen/Tag 2,33 ± 4,15 vs. 3,93 ± 2,44 (p = 0,001) sowie einen höheren HbA1c 7,9 ± 1,2 vs. 8,3 ± 1,4% (p = 0,004) und geringere diabetesbezogene Belastungen 26,77 ± 19,39 vs. 23,61 ± 16,21 (p = 0,097). Gleichzeitig zeigte die ICT-Stichprobe eine signifikant geringere Lebensqualität als die NIT-Stichprobe (0,86 ± 0,16 vs. 0,81 ± 0,21; p = 0,019). In einer multivariaten Analyse hatten diabetesbezogene Belastungen den größten Einfluss auf die Lebensqualität (β=-0,24; p = 0,001), gefolgt von der Anzahl der Folgekomplikationen (β=-0,14; p = 0,005), weiblichem Geschlecht (β=-0,13; p = 0,013), erhöhtem BMI (β=-0,12; p = 0,018). Die Therapieform blieb ein signifikanter Prädiktor (β=-0,12; p = 0,028). Alter, Diabetesdauer, HbA1c und Blutzuckerselbstkontrollen/Tag hatten multivariat keinen signifikanten Einfluss auf die Lebensqualität. Schlussfolgerungen: Patienten mit einer ICT berichten eine signifikant geringere Lebensqualität als Patienten mit einer NIT. Dieser Unterschied bleibt auch multivariat nach Kontrolle demographischer und diabetesspezifischer Variablen bestehen. Aufgrund ihres großen Einflusses sollten diabetesbezogene Belastungen in der Behandlung von Typ-2-Diabetikern größere Beachtung finden. Übergewichtige Patienten mit Folgeerkrankungen scheinen eine Risikogruppe für eine reduzierte Lebensqualität zu bilden

Randomized Controlled Clinical Trial of Blood Glucose Awareness Training (BGAT III) in Switzerland and Germany

Although both diabetes and the efficacy of medical management are international issues, psycho-educational interventions might be culturally bound. Blood Glucose Awareness Training (BGAT) is a psycho-educational program for patients with type 1 diabetes mellitus. It is focused on improving recognition and management of extreme blood glucose levels, and is the best documented American psycho-educational program for this purpose. A randomized controlled clinical trial of BGAT's long-term benefits in a non-American setting has been lacking. One hundred and eleven adults with type 1 diabetes mellitus from Switzerland and Germany participated. After a 6 months baseline assessment, subjects were randomly assigned to receive either 2 months of BGAT (n = 56) or a physician-guided self-help control intervention (n = 55). BGAT improved recognition of low (p = 0.008), high (p = .03), and overall blood glucose (p = 0.001), and reduced frequency of severe hypoglycemia (p = 0.04), without compromising metabolic control. BGAT reduced both the external locus of control (p < 0.02) and fear of hypoglycemia (p < 0.02). BGAT was efficacious in reducing adverse clinical events and achieving clinically desirable goals in a European, as well as American settin

The use of CGM to identify type 1 diabetic patients with hypoglycemia problems and its impact for avoidance of biochemical hypoglycemia.

This cross-over study used a CGM system (DexCom SEVEN PLUS CGM). In a randomized order, participants had either no access (CGM blind) or real time access to current glucose data (CGM open). One objective was to analyze if type 1 diabetic patients with hypoglycemia problems (at least one episode requiring third party assistance) could be identifi ed by the use of the blinded CGM data. We also analyzed the impact of CGM use on biochemical hypoglycemia. Type 1 diabetic patients with hypoglycemia problems had signifi cant longer diabetes duration (17.0 vs. 11.0 yrs.), a higher unawareness score (4.0 vs. 2.0) and lower thresholds for detecting hypoglycemia (50.0 vs. 65.0 mg/dl) than patients without hypoglycemia problems. During the blinded CGM phase patients with hypoglycemic problems had a signifi cant longer duration of low glucose phases 248 vs. 153 minutes per day (p=.037; <70 mg/dl) respectively 173 vs. 96 minutes per day (p=.041; <60 mg/dl). Area under the receiver operating curve (ROC 0.72 p=.03) indicated a suffi cient screening performance of the duration of low glucose periods (< 70 mg/dl) for the identifi cation of patients with hypoglycemia problems. A cut-off of 170 minutes per day of time spend in the low glucose range had a sensitivity of 75% and a specifi city of 70.3%; the positive predictive value was 52.9%, the negative predictive value was 86.4%. A comparison of blind vs. open CGM showed that time spend in a low glucose range could be signifi cantly more reduced in patients with hypoglycemia problems than in patients without hypoglycemia problems during CGM open (< 60 mg/dl; - 67.8 min per day p=.040; < 50 mg/dl; -50.6 min per day, p=.038; < 40 mg/dl; -41.4 min. per day, p=.03). This study shows that CGM has an unused potential for identifying type 1 diabetic patients at risk for hypoglycemia problems in clinical practice as well as for avoidance of biochemical hypoglycemia, which plays a pivotal role for the development of hypoglycemia associated autonomic failure

The impact of continuous glucose monitoring (CGM) on low interstitial glucose values and low blood glucose values assessed by Point-of-Care glucose meters (POC-GM).

The impact of CGM on the duration of periods with low glucose measured in interstitial fl uid is well known. But studies showing an impact of CGM on low blood glucose values, measured by POC-GM are rare. This crossover study examines the impact of CGM on duration of periods spent in low interstitial glucose range (70 mg/dl) as well as on the proportion of low blood glucose (BG) values measured by POC-GM (Glukometer 3000, Bio Sensor Technology, Germany)and time until detection of low BG by use of POC-GM. 41 type 1 diabetic patients (age 42.0 ±11.3 yrs, diabetes duration 15.3 ±10.1; A1c 8.2 ±1.4%) used the DEXCOM 7 Plus CGM system twice; once participants were blinded against the results and in the other study phase (Open GCM) patients received real-time glucose values and current glucose trends, used the CGM data to determine their insulin dose, and were alerted if hypoglycaemic or hyperglycaemic glucose ranges were approached. In addition, BG was routinely measured 6 times a day by POC-GM. The order of study phases was randomized. The time spent in a hypoglycaemic glucose range (< 70 mg/dl) was reduced by open CGM from 180.6 ±125 to 125 ± 89.2 minutes per day (p=.005). Also time spent in the euglycemic glucose range was increased from 946 ±176 to 1023 ±168 minutes per day (p=.003). Open CGM reduced the proportion of low BG measurements by POC-GM from 10.3 ±7.6% to 7.4 ±5.8% (p=.039), whereas the euglycemic POC readings was increased from 68.3 ±12.1% to 73.7 ±12.1% (p=.007). The time until a hypoglycaemic BG value was detected by POC-GM was signifi cantly (p.028) shortened by 33.1 (95% CI 3.8 -62.3) minutes. These results demonstrate that CGM used for insulin dosing and hypoglycaemia alerts not only diminishes low interstitial glucose values but also reduces the proportion of low BG measured by POC-GM. In addition the time for the detection of a hypoglycaemic episode by POC-GM was signifi cantly shortene

Entwicklung und Evaluation eines Assessment-Tools zur Erfassung von Barrieren der Blutzuckerselbstkontrolle.

Einleitung: Eine regelmäßige Blutzuckerselbstkontrolle ist ein wesentlicher Bestandteil für eine erfolgreiche Anpassung oder Überprüfung der Diabetestherapie. Viele Patienten berichten Barrieren, die einer regelmäßigen Blutzuckerselbstkontrolle im Alltag entgegenstehen. In dieser Studie wurde ein Assessment-Tool für die Erfassung solcher Barrieren entwickelt und evaluiert. Methodik: Patienteninterviews zu Erfahrungen mit der Blutzuckerselbstkontrolle wurden durchgeführt und ausgewertet. Folgende Aspekte erwiesen sich in Bezug auf die Blutzuckerselbstkontrolle als relevant: Handling im Alltag („Zu viele Utensilien sind notwendig“), psychologische Barrieren der Glukosekontrolle („Blutzuckerselbstkontrolle in der Öffentlichkeit ist peinlich“), Zuverlässigkeit der Blutzuckerselbstkontrolle („Vertrauen in die gemessenen Blutzuckerwerte“), aber auch Vorteile der Blutzuckerselbstkontrolle („Blutzuckermessungen vermitteln ein Sicherheitsgefühl“). Zur Evaluation wurden Faktoren- und Itemanalysen vorgenommen. Ergebnisse: 60 Fragebogenitems wurden einer diabetischen Stichprobe (n = 140) mit intensivierter Insulintherapie (Alter 43,6 ± 15,3J., 70% Typ-1-Diabetes, HbA1c 8,8 ± 2,1%; 53% weiblich) vorgegeben. Die Faktorenanalyse ergab 4 Skalen mit insgesamt 18 Items, die alle zufriedenstellende Reliabilitätskennwerte erreichten („Handling“ Cronbachs a = 0,84; „psychologische Barrieren“ a = 0,74, „Zuverlässigkeit“ a = 0,82 und „Vorteile der Blutzuckerselbstkontrolle“ a = 0,72). Ein hoher HbA1c Wert war signifikant mit höheren psychologischen Barrieren (r = 0,20) und geringerem Vertrauen in die Zuverlässigkeit (r = 0,32) sowie geringeren Vorteilen der Blutzuckerselbstkontrolle (r = 0,32) assoziiert. Höheres Lebensalter (r = 0,32) und längere Diabetesdauer (r = 0,19) waren mit weniger psychologischen Barrieren der Blutzuckerselbstkontrolle korreliert. Patienten, welche mehr psychologische Barrieren berichteten, testeten seltener ihren Blutzucker (r =-0,26). Schlussfolgerung: Das neue entwickelte Assessment-Tool zur Erfassung von Barrieren der Blutzuckerselbstkontrolle hat eine gute Reliabilität sowie Validität. Zudem ist es in der Lage, praktische Barrieren einer Blutzuckerselbstkontrolle bei Diabetespatienten zu identifizieren. Unterstützt durch Abbott Diabetes Care, German