Psychosocial aspects of closed- and open-loop insulin delivery: closing the loop in adults with Type 1 diabetes in the home setting.

AIMS: To explore the psychosocial experiences of closed-loop technology and to compare ratings of closed- and open-loop technology for adults with Type 1 diabetes taking part in a randomized crossover study. METHODS: Adults (aged > 18 years) on insulin pump therapy were recruited to receive a first phase of either real-time continuous glucose monitoring with overnight closed-loop or real-time continuous glucose monitoring alone (open-loop) followed by a second phase of the alternative treatment in random order, at home for 4 weeks, unsupervised. Participants were invited to share their views in semi-structured interviews. The impact of the closed-loop technology, positive and negative aspects of living with the device overnight, along with the hopes and anxieties of the participants, were explored. RESULTS: The participants in the trial were 24 adults with a mean (sd) age of 43 (12) years, of whom 54% were men. The mean (range) interview duration was 26 (12-46) min. Content and thematic analysis showed the following key positive themes: improved blood glucose control (n = 16); reassurance/reduced worry (n = 16); improved overnight control leading to improved daily functioning and diabetes control (n = 16); and improved sleep (n = 8). The key negative themes were: technical difficulties (n = 24); intrusiveness of alarms (n = 13); and size of equipment (n = 7). Of the 24 participant, 20 would recommend the closed-loop technology. CONCLUSIONS: Closed-loop therapy has positive effects when it works in freeing participants from the demands of self-management. The downside was technical difficulties, particularly concerning the pump and 'connectivity', which it is hoped will improve. Future research should continue to explore the acceptability of the closed-loop system as a realistic therapy option, taking account of user concerns as new systems are designed. Failure to do this may reduce the eventual utility of new systems.

Flexible Lifestyles for Youth (FL3X) behavioural intervention for at-risk adolescents with Type 1 diabetes: a randomized pilot and feasibility trial.

AIM: To determine the potential effect sizes for the Flexible Lifestyle for Youth (FL3X) behavioural intervention to improve glycaemic control (HbA(1c)) and quality of life for at-risk adolescents with Type 1 diabetes. METHODS: Participants [n = 61; age 12-16 years, HbA(1c) 64-119 mmol/mol (8-13%)] were randomized to FL3X (minimum three sessions) or usual care. Effect sizes (Cohen's d), comparing the mean difference between the groups, were calculated. RESULTS: Study retention (95%), attendance at intervention sessions (87% attended all three sessions) and acceptability were high (100% of the adolescents and 91% of parents would recommend the programme to others). Overall, 41% of participants in the intervention group and 24% of participants in the control group were 'responders' [HbA(1c) decreased by > 6 mmol/mol (0.5%); d = 0.37]. HbA(1c) levels decreased (d = -0.18), diabetes-specific quality of life increased (d = 0.29), but generic quality of life decreased (d = -0.23) in the intervention compared with the control group. CONCLUSIONS: The FL3X programme merits further study for improving HbA(1c) and diabetes-specific quality of life in adolescents with Type 1 diabetes. (Clinical trials registry no.: NCT01286350).

Comparison of longitudinal point-of-care and high-performance liquid chromatography HbA1c measurements in a multi-centre trial.

AIMS: Point-of-care HbA(1c) is routine in clinical practice. Comparison of point-of-care HbA(1c) against laboratory measurements across sites and over time is warranted. METHODS: One hundred and twenty-one young persons with Type 1 diabetes from four centres provided 450 paired samples collected over 10 months for point-of-care HbA(1c) and central laboratory-based high-performance liquid chromatography (HPLC) HbA(1c) determinations. Change in HbA(1c) over time was assessed by difference from initial to final HbA(1c) and by growth modelling with annualized slope calculation. Change in HbA(1c) was categorized as improved (decrease of ≥ 0.5% or negative slope), no change (± 0.4% of initial HbA(1c) or slope = 0) or worsened (increase of ≥ 0.5% or positive slope). RESULTS: The 450 paired samples (median of four pairs/patient) were highly correlated (r = 0.97, P < 0.0001), as were time-specific and site-specific pairs (r = 0.94 to 0.98, P < 0.0001). Initial-to-final point-of-care HbA(1c) and HPLC HbA(1c) changes were 0.3 ± 1.1% (range -2.7 to 4.1) and 0.4 ± 1.2% (-3.9 to 4.5), respectively, with 21% of patients (n = 26) discordant for change categories. ΔHbA(1c) by point-of-care HbA(1c) vs. HPLC HbA(1c) differed across the HbA(1c) range and by ≥ 0.5% absolute difference in ΔHbA(1c) in 14 (54%) of the 26 patients discordant for HbA(1c) change categories. Mean annual HbA(1c) slope was 0.4 ± 1.5% (-5.4 to 4.8) for point-of-care HbA(1c) and 0.4 ± 1.6% (-6.9 to 5.2) for HPLC HbA(1c), with 18% (n = 22 pairs) discordant for change categories. CONCLUSIONS: Assessment of absolute HbA(1c) change may not be different for point-of-care HbA(1c) compared with HPLC HbA(1c); however, misclassification of patients by discrete cut-off values may occur with point-of-care HbA(1c) compared with HPLC HbA(1c) determinations.

Validation of an abbreviated adherence measure for young people with Type 1 diabetes.

AIMS: Adherence to diabetes-related tasks is an important construct. The Diabetes Self-Management Profile is a validated, semi-structured interview assessing adherence in paediatric patients with Type 1 diabetes. We created and validated a brief questionnaire version of the Diabetes Self-Management Profile called the Diabetes Self-Management Questionnaire. METHODS: Young people with Type 1 diabetes, ages 9-15 years (n = 338) and their parents provided data from chart review, interview and questionnaires. RESULTS: Diabetes Self-Management Questionnaire scores correlated significantly with Diabetes Self-Management Profile scores, HbA(1c) , blood glucose monitoring frequency and other measures associated with adherence and/or glycaemic control (P ≤ 0.01 for all). Young people and parent scores were correlated (r = 0.55, P < 0.0001). The Diabetes Self-Management Questionnaire demonstrated modest internal consistency (Cronbach's α = 0.59), adequate for a brief measure of multidimensional adherence. In addition, factor analysis confirmed one factor. CONCLUSIONS: This brief adherence questionnaire demonstrated construct validity in young people 9-15 years old and their parents and may have utility in clinical and research settings.

Satisfaction with continuous glucose monitoring in adults and youths with Type 1 diabetes.

AIMS: To describe satisfaction with continuous glucose monitoring in Type 1 diabetes; to correlate continuous glucose monitoring satisfaction scores with usage; and to identify common themes in perceived benefits and barriers of monitoring reported by adults, youths and the parents of youths in the Juvenile Diabetes Research Foundation continuous glucose monitoring trials. METHODS: The Continuous Glucose Monitoring Satisfaction Scale questionnaire was completed after 6 months of monitoring. Participants also answered open-ended queries of positive and negative attributes of continuous glucose monitoring. RESULTS: More frequent monitoring was associated with higher satisfaction for adults (n = 224), youths (n = 208) and parents of youths (n = 192) (all P < 0.001) in both the 'benefits' and 'hassles' sub-scales of the Continuous Glucose Monitoring Satisfaction Scale, but the greatest differences between the two groups involved scores on hassle items. Common barriers to monitoring use included insertion pain, system alarms and body issues; while common benefits included glucose trend data, opportunities to self-correct out-of-range glucose levels and to detect hypoglycaemia. CONCLUSIONS: As frequent use of continuous glucose monitoring is associated with improved glycaemic control without increased hypoglycaemia it is important to overcome barriers, reinforce benefits and set realistic expectations for this technology in order to promote its more consistent and frequent use in individuals with Type 1 diabetes.

DNAzymes to mouse beta1 integrin mRNA in vivo: targeting the tumor vasculature and retarding cancer growth.

Previously, we designed a DNAzyme (beta1DE) targeting the human beta1 integrin subunit, which efficiently digested the mRNA of the beta1 integrin subunit and downregulated beta1 integrin expression in endothelial cells. This DNAzyme blocked the adhesion of endothelial cells and abolished their ability to form microcapillary tubes in Matrigel. In our present study, we demonstrate that beta1DE effectively inhibited neovascularization in Matrigel plugs (BALB/c mice, n=20) and solid human carcinoma tumors developed in nude mice (BALB/cA nude (nu-/-)-B6.Cg-Foxn1(nu)) (n=30) using prostate carcinoma cells PC-3 (n=15) and colon adenocarcinoma cells CX1.1 (n=15). When injected intratumorally, it significantly reduced the tumor size and number of microvessels developed by both CX1.1 and PC-3 cells within the 3 weeks of experiment duration. Thus, DNAzymes targeting beta1 integrin genes can inhibit multiple key tumorigenic processes in vitro and in vivo and may serve as useful anti-cancer agents.

Quality of life in children with Type 1 diabetes: a comparison of general and diabetes-specific measures and support for a unitary diabetes quality-of-life construct.

AIMS: To assess the factor structure of the Pediatric Quality of Life Inventory (PedsQL) Diabetes Module and to compare the PedsQL general and diabetes-specific quality of life (QOL) measures regarding psychometric properties and relations to relevant outcomes. METHODS: The instruments were completed by 447 children age 9 to 15.5 years with Type 1 diabetes > 1 year from four US paediatric diabetes clinics; parents completed the parallel parent-proxy measures. Principal components factor analysis was used to examine the factor structure of the PedsQL diabetes module. Analyses of the generic and diabetes QOL measures included psychometric properties, parent-child correlations and correlations with depression, adherence and glycated haemoglobin (HbA(1c)). RESULTS: The factor structure of the PedsQL diabetes module did not support the original five subscales. Both one- and two-factor models were supported; however, parallel parent and child subscales did not emerge. While the generic and diabetes-specific measures of QOL were moderately to highly correlated with each other, the constructs were differentially associated with relevant diabetes outcomes. Generic QOL was more highly associated with depression than diabetes QOL. Conversely, diabetes QOL was more highly associated with adherence and HbA(1c), although this was seen to a greater extent for parent-proxy report than for child report. CONCLUSIONS: Factor analysis of the PedsQL diabetes module supports the use of a total diabetes QOL score. Findings regarding the associations of the generic and diabetes modules with diabetes outcomes underscore the unique contribution provided by both generic and diabetes QOL.

Psychosocial therapies in diabetes: report of the Psychosocial Therapies Working Group.

OBJECTIVE: To review key advances in the behavioral science literature related to psychosocial issues and therapies for persons with diabetes, to discuss barriers to research progress, and to make recommendations for future research. RESEARCH DESIGN AND METHODS: Key findings from the literature on psychosocial research in diabetes are reviewed separately for children and adults. Specific issues covered include psychosocial adjustment and psychiatric disorders, neurocognitive functioning, quality of life, and psychosocial therapies. Barriers that must be addressed to allow research in this area to progress are discussed. Recommendations are then made concerning high-priority areas for advancing research in the field. CONCLUSIONS: A substantial amount of behavioral science research has demonstrated that psychosocial factors play an integral role in the management of diabetes in both children and adults. Research has also shown the efficacy of a number of psychosocial therapies that can improve regimen adherence, glycemic control, psychosocial functioning, and quality of life. More research in this area is needed to develop psychosocial intervention programs for specific patient populations and to demonstrate the cost-effectiveness of these approaches.

Behavior therapy for families of adolescents with diabetes: maintenance of treatment effects.

OBJECTIVE: This study reports 6- and 12-month follow-up for the families of adolescents with diabetes who participated in a trial of Behavioral-Family Systems Therapy (BFST). RESEARCH DESIGN AND METHODS: A total of 119 families of adolescents with type 1 diabetes were randomized to 3 months of treatment with either BFST, an education and support (ES) group, or current therapy (CT). Family relationships, adjustment to diabetes, treatment adherence, and diabetic control were assessed at baseline, after 3 months of treatment, and 6 and 12 months later. This report focuses on the latter two evaluations. RESULTS: Compared with CT and ES, BFST yielded lasting improvements in parent-adolescent relationships and diabetes-specific conflict. Delayed effects on treatment adherence emerged at 6- and 12-month follow-ups. There were no immediate or delayed effects on adolescents' adjustment to diabetes or diabetic control. CONCLUSIONS: BFST yielded lasting improvement in parent-adolescent relationships and delayed improvement in treatment adherence, but it had no effect on adjustment to diabetes or diabetic control. A variety of adaptations to BFST could enhance its impact on diabetes outcomes.

Validation of a structured interview for the assessment of diabetes self-management.

OBJECTIVE: The authors developed and validated a semi-structured interview; the Diabetes Self-Management Profile (DSMP), to measure self-management of type 1 diabetes. The DSMP includes the following regimen components: exercise, management of hypoglycemia, diet, blood glucose testing, and insulin administration and dose adjustment. RESEARCH DESIGN AND METHODS: Families of youths with type 1 diabetes (n = 105) who were entering a controlled trial of intensive therapy (IT) versus usual care (UC) were administered the DSMP Analyses assessed the reliability and validity of the DSMP, including its associations with HbA1c and quality of life. RESULTS: The DSMP total score has adequate internal consistency (Cronbach's alpha 0.76), 3-month test-retest reliability (Pearson correlation, r = 0.67), inter-interviewer agreement (r = 0.94), and parent-adolescent agreement (r = 0.61). DSMP total scores (r = -0.28) and 3 subscales correlated significantly with HbA1c (diet [r = -0.27], blood glucose testing [r = -0.37], and insulin administration and dose adjustment [r = -0.25 ]). Adolescents' reports of self-management did not differ from parental reports. Higher DSMP scores were associated with more favorable quality of life for mothers and youths. CONCLUSIONS: The DSMP is a convenient measure that yields a reliable and valid assessment of diabetes self-management. Compared with extant similar measures, the DSMP is more strongly correlated with HbA1c.

Randomized, controlled trial of behavior therapy for families of adolescents with insulin-dependent diabetes mellitus.

OBJECTIVE: To describe the short-term results of a controlled trial of Behavioral Family Systems Therapy (BFST) for families of adolescents with diabetes. METHODS: We randomized 119 families of adolescents with diabetes to 3 months' treatment with either BFST, an education and support Group (ES), or current therapy (CT). Family relationships, psychological adjustment to diabetes, treatment adherence and diabetic control were assessed at baseline, after 3 months of treatment (reported here), and 6 and 12 months later. RESULTS: Compared with CT and ES, BFST yielded more improvement in parent-adolescent relations and reduced diabetes-specific conflict. Effects on psychological adjustment to diabetes and diabetic control were less robust and depended on the adolescent's age and gender. There were no effects on treatment adherence. CONCLUSIONS: BFST yielded some improvement in parent-adolescent relationships; its effects on diabetes outcomes depended on the adolescent's age and gender. Factors mediating the effectiveness of BFST must be clarified.

Use of a preanesthetic video for facilitation of parental education and anxiolysis before pediatric ambulatory surgery.

UNLABELLED: In this study, we evaluated the effects of viewing an educational videotape about pediatric anesthesia on measures of parental knowledge of anesthesia and preoperative anxiety using a randomized, controlled design. During their routine preoperative visit, 85 parents of children scheduled to undergo ambulatory surgical procedures under general anesthesia were randomized to view either the experimental videotape about pediatric anesthesia or a control videotape with no medical content. Before and immediately after viewing the assigned videotape, parents completed measures of situational anxiety (State-Trait Anxiety Inventory-State), preoperative anxiety and need for information (Amsterdam Preoperative Anxiety and Information Scale), and anesthesia knowledge (Standard Anesthesia Learning Test). Repeated-measures analyses of variance showed that parents who viewed the experimental videotape showed a significant increase in anesthesia knowledge (P < 0.022) and a significant reduction in their state of anxiety (P < 0.031), anesthesia-specific anxiety, and need for information (P < 0.0001) compared with the control group. These results demonstrated that viewing a preoperative educational videotape about pediatric anesthesia can provide immediate educational and anxiolytic benefits for parents of children undergoing ambulatory surgery. The duration of these benefits remains to be determined. IMPLICATIONS: In this study, we demonstrated the benefits of viewing an educational videotape about pediatric anesthesia on measures of parental knowledge of anesthesia and preoperative anxiety using a randomized, controlled design. We found that videotape viewing facilitated preoperative preparation and lessened preoperative anxiety.

Validation of measures of parents' preoperative anxiety and anesthesia knowledge.

UNLABELLED: Parents' anxiety about their children's anesthesia may adversely affect the children's outcomes and compromise the quality of informed consent. Studies of these issues have been limited by the lack of validated measures of parental anxiety and knowledge surrounding anesthesia. In the present study, we evaluated psychometric properties of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) and the Standard Anesthesia Learning Test (SALT) among 85 parents who participated in an evaluation of the effects of a videotape about pediatric anesthesia. The results supported the internal consistency, test-retest reliability, and concurrent validity of both instruments and documented the equivalence of two forms of the SALT. Factor analysis supported the previously demonstrated factor structure of the APAIS, further confirming its construct validity. We conclude that the APAIS and SALT are reliable and valid measures of parental anxiety and knowledge of pediatric anesthesia that can be used for clinical and research purposes. IMPLICATIONS: This study verified the reliability and validity of two questionnaires for measuring parents' knowledge and anxiety about pediatric anesthesia. These questionnaires can be used in further research on factors affecting parental anxiety and knowledge before their children's surgery.

[Continuous arteriovenous hemofiltration in the management of patients with shock and multiorgan insufficiency syndrome]. / Samoistna ciagla tetniczo-zylna hemofiltracja w leczeniu chorych we wstrzasie z zespolem niewydolnosci wielonarzadowej.

Spontaneous continuous arterio-venous hemofiltration (CAVH) is a blood purification system based on blood filtration through capillary hemofilters without pumps, using the arterio-venous pressure gradient for blood perfusion. In 2-nd Department of Surgery of Medical University of Gdansk in the years 1989-1996 we introduced CAVH 13 times in 6 women and 7 men, aged from 17 till 79 years. We used this technique to maintain fluid balance in anuric patients needing parenteral fluids. Due to circulatory and respiratory insufficiency all patients needed catecholamines infusion and controlled respiration. In 7 patients acute renal failure was caused by septic shock and in 6 patients by shock after severe multiorgan injuries. The CAVH therapy lasted from 3 till 16 days. The stabilisation of hemodynamic and renal parameters was observed in all patients. 3 patients died of cranio-cerebral injuries and 2 due to longlasting septic shock induced by necrotic pancreatitis. In all patients CAVH was required to remove the excess water given as carrier in total parenteral nutrition. Experience with 13 cases has shown the CAVH technique, to be particularly useful in patients with vascular instability or severe fluid overload. The above method which needs no technical investment is simple to handle.

Social validity of support group and behavior therapy interventions for families of adolescents with insulin-dependent diabetes mellitus.

Compared the social validity of behavior therapy vs. support group interventions for reduction of parent-adolescent conflict among families of adolescents with diabetes. Families were randomized to 10 sessions of an Education and Support group (ES) or 10 sessions of Behavioral Family Systems Therapy (BFST). We compared participants' social validity ratings of BFST and ES using the Treatment Evaluation Questionnaire (TEQ). Mean TEQ scores were significantly more positive for BFST than ES and, for 13 of 20 items, BFST was rated significantly more positively by parents and/or adolescents. Adolescents rated ES less positively than did parents. Fathers' responses reflected fewer differences between ES and BFST. Results extend previous research on BFST and confirm its superiority over ES for targeting family conflict.

Psychometric properties and normative data for the parent version of the diabetes independence survey.

The parent version of the Diabetes Independence Survey measures parents' perceptions of their children's mastery of 38 diabetes self-care skills. The instrument was administered to 648 parents of 622 children with insulin-dependent diabetes mellitus, ages 3 and 18 years, at seven different pediatric medical centers. Data confirming the internal consistency, interrater reliability, construct validity, and concurrent validity of the instrument are presented in this paper. Age-adjusted normative data for total scores on the instrument as well as item-by-item data on the ages at which mastery of each skill was reported by 25%, 50%, and 75% of parents also are discussed. The Diabetes Independence Survey can be used as a reliable, valid, and efficient research tool for assessing the growth and development of diabetes knowledge and skills among children and adolescents, and as a screening instrument and program evaluation tool for clinical purposes.

The influence of organizational culture on patient care restructuring.

University Medical Center in Tucson, Arizona, embarked on a 3-year patient care restructuring project that altered all the patient care delivery systems throughout the organization. In the patient care services areas, patient care managers faced many new challenges in dealing with changes in professional practice and the introduction of multiskilled workers. The influence of the existing organizational culture on patient care restructuring was identified as an important factor to assess early into the project to ensure successful change. The Cultural Assessment Survey (CAS) was used to evaluate unit culture on the four pilot units (two Adult Health and two Pediatric). The results of the survey, implications for managers, and organizational culture are discussed.

Deviation from developmentally appropriate self-care autonomy. Association with diabetes outcomes.

OBJECTIVE: Treatment of IDDM in youth emphasized balancing children's self-care autonomy with their psychological maturity. However, few data exist to guide clinicians or parents, and little is known about correlates of deviations from this ideal. RESEARCH DESIGN AND METHODS: In this cross-sectional study, IDDM self-care autonomy of 100 youth was assessed using two well-validated measures. Three measures of psychological maturity (cognitive function, social-cognitive development, and academic achievement) were also collected for each child. Composite indexes of self-care autonomy and of psychological maturity were formed, and the ratio of the self-care autonomy index to the psychological maturity index quantified each child's deviation from developmentally appropriate IDDM self-care autonomy. Based on these scores, participants were categorized as exhibiting constrained (lower tertile), appropriate (middle tertile), or excessive (higher tertile) self-care autonomy. Between-group differences in treatment adherence, diabetes knowledge, glycemic control, and hospitalization rates were explored. RESULTS: Analysis of covariance controlling for age revealed that the excessive self-care autonomy group demonstrated less favorable treatment adherence, diabetes knowledge, hospitalization rates, and, marginally, glycemic control. Excessive self-care autonomy increased with age and was less common among intact two-parent families but was unrelated to other demographic factors. CONCLUSIONS: The findings indicate caution about encouragement of maximal self-care autonomy among youth with IDDM and suggest that families who succeed in maintaining parental involvement in diabetes management may have better outcomes.

Associations among teen-parent relationships, metabolic control, and adjustment to diabetes in adolescents.

Extended previous studies of adolescents with insulin-dependent diabetes mellitus (IDDM) that have implicated family conflict as a correlate of poor adaptation to the disease and inadequate diabetic control. Families of 115 adolescents with IDDM completed the Parent-Adolescent Relationship Questionnaire (PARQ) and the Teen Adjustment to Diabetes Scale (TADS) and recent glycohemoglobin levels were retrieved from medical records for 82 patients. PARQ scores of families of adolescents with IDDM were similar to those of a healthy normative group. Multiple regression analysis showed that a PARQ scale measuring family communication and conflict resolution skills was a strong predictor of the IDDM outcome variables, suggesting that these families could derive health and behavioral benefits from an intervention that improves parent-adolescent communication skills. Controlled trials of such interventions are needed.