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).

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.

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.

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.

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.

Survey of diabetes professionals regarding developmental changes in diabetes self-care.

There are no empirically obtained data defining appropriate developmental expectations for the acquisition of self-care independence by children with insulin-dependent diabetes mellitus. This study surveyed diabetes professionals about their estimates of ages at which children typically master 38 diabetes skills. The 229 survey respondents represented a broad range of professions and clinical settings and had extensive experience as diabetes professionals. Mean mastery age estimates were less than 14 yr for the 38 skills assessed. Responses to each item were variable among respondents, with a mean SD of 2.1 yr in estimated mastery ages for all items. Estimated mastery ages were below the age ranges recommended by the American Diabetes Association for 14 of 20 comparable skills. Physicians generally expected the diabetes skills to be mastered at later ages than did nurses or other health-care professionals. There were no other consistent response patterns related to respondent characteristics, i.e., years of clinical experience, employment setting, current patient load, or method of survey distribution.

Adjustment to diabetes mellitus in preschoolers and their mothers.

Although preschool-aged children with diabetes might be at increased risk for both general and disease-specific psychological adjustment difficulties, this issue has not been investigated. We evaluated both general and diabetes-related adjustment of 20 preschool-aged children and their mothers. The mothers completed the Child Behavior Checklist, Parenting Stress Index, Parents' Diabetes Opinion Survey, and the Preschool Diabetes Behavior Checklist. The latter measure was constructed specifically for this study to measure the frequency of oppositional and avoidance behaviors of children regarding diabetes management tasks. Mothers reported that their children displayed significantly more internalizing behavior problems (anxiety, depression, withdrawal) and were a significantly greater source of parental stress compared with corresponding nondiabetic normative group samples. Also, certain maternal attitudes about diabetes and its treatment were correlated with the children's disease-specific behavior problems. The children's general psychological adjustment, however, was not predictive of these diabetes-specific behavior problems.

Use of blood glucose data by families of children and adolescents with IDDM.

OBJECTIVE: Prospective evaluation of the use of blood glucose test results for treatment actions by families of youth with IDDM. RESEARCH DESIGN AND METHODS: Forty-seven patients with IDDM used reflectance meters with memory for SMBG for 28 days. Parents kept weekly diaries of six types of uses of SMBG data. We collected SMBG data from the reflectance meters, HbA1 and serum fructosamine assays, and measures of behavioral factors that could affect use of SMBG data. RESULTS: Families recorded a mean of 4.85 data-based actions during the 28-day study, and 74% of the families reported at least one such action. Fifty percent of recorded actions consisted of management of hypoglycemia and, among the remainder, only 18% were anticipatory, proactive actions. Partial correlation analysis showed that families with more frequent use of SMBG data had less parent-child conflict about diabetes, more diabetes knowledge, and better overall treatment adherence. Use of SMBG data was unrelated to objective indices of the need for treatment adjustments or to diabetic control. CONCLUSIONS: Most families made active use of their SMBG data, but few of these actions were proactive. Behavioral factors were stronger predictors of family use of SMBG data than were objective indices of the need for treatment adjustments. The results illustrate the need for further research on use of SMBG data and methods to enhance its impact on diabetic control.

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.

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.

Parental and professional estimates of self-care independence of children and adolescents with IDDM.

OBJECTIVE: To report the results of a survey of 490 parents of children with insulin-dependent diabetes mellitus (IDDM) regarding the children's mastery of 38 diabetes-care skills. Parental responses are contrasted with those of a previous survey in which 229 diabetes professionals estimated ages at which typical children with IDDM master the same skills. RESEARCH DESIGN AND METHODS: Parents were recruited at five pediatric endocrinology clinics with a response rate of 88.9%. RESULTS: For 33 of 38 skills, professionals' median mastery age estimates exceeded, by greater than or equal to 1 yr, the median ages that parents reported skill mastery by their estimates, children. Despite the parent-professional disagreement about mastery-age their survey responses yielded substantial agreement about the order of mastery of specific skills. The data also revealed two profiles of comparative results. For many items, parents reported earlier skill mastery, but parental and professional estimates eventually converged during adolescence. These skills consisted of rote, motoric acts, or more complex tasks for which errors yield relatively certain aversive consequences. For other skills, more professional estimated skill mastery among adolescents than did parents. These skills required substantial organization and self-regulation by the adolescent, involved treatment components for which the aversive consequences of errors are deferred and uncertain, or they were skills infrequently required of most patients with IDDM. CONCLUSIONS: The parent-professional discordance revealed by this survey illustrates the importance of clear specification of treatment responsibilities, careful monitoring of self-care competence, and periodic reeducation of children with IDDM.

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.

Blood glucose monitoring by diabetic adolescents: compliance and metabolic control.

Self-monitoring of blood glucose (SMBG) is used in the management of diabetes to guide insulin and diet adjustments. However, SMBG has not achieved its potential impact on diabetic control, perhaps due to poor compliance. Research on SMBG compliance interventions has been hampered by a lack of reliable and practical methods of behavioral assessment. The appearance of reflectance meters with memory permits precise, yet efficient, measurement of SMBG behaviors, allowing more effective interventions. This study evaluated a behavioral contract for SMBG compliance among diabetic adolescents, using reflectance meters with memory to assess the target behavior. Thirty patients were randomized to either meter-alone or meter-plus-contract conditions; an additional 12 patients served in a conventional-therapy control group. Compliance for the meter-alone group declined sharply during the 16-week intervention, whereas it remained at or above baseline levels for the meter-plus-contract group. Despite the large between-groups differences in SMBG frequency, both groups showed equal, moderate improvement in measures of diabetic control, suggesting that SMBG frequency had little impact on health status in this sample. There were no intervention-specific effects on overall diabetes compliance or patient or parent adjustment to diabetes. Few of the measured patient characteristics were significant predictors of treatment response. Further research into maximizing the therapeutic impact of SMBG is needed.

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.

Diabetes mellitus in the transition to adulthood: adjustment, self-care, and health status.

A cross-sectional study of health and adjustment among 18 to 22-year-old patients with insulin-dependent diabetes mellitus (IDDM) is reported. Objectives were to examine coping with IDDM in this age group; to identify predictors of health status, treatment adherence, and health care use; and to provide a retrospective evaluation of the persistence of IDDM-specific adjustment from earlier through later adolescence. Multiple validated measures, interviews of independent informants, and biochemical assays were used to assess psychological, behavioral, and metabolic status. Patients and parents completed a retrospective measure of the patient's adjustment to IDDM during earlier adolescence. Findings (n = 81) indicated: (1) normal rates of general psychopathology but some evidence of poorer adjustment to IDDM relative to other age groups, (2) poor diabetic control and high incidence of microalbuminuria, (3) specific factors associated differentially with treatment compliance, health care use, diabetic control, and microalbuminuria among late adolescents, and (4) evidence that poor adjustment to IDDM in earlier adolescence persists into the transition to adulthood. The findings imply that late adolescents with IDDM are at risk of various unfavorable behavioral and health outcomes and that adjustment to the disease during earlier adolescence may be a predictor of subsequent health-related behavior and health status. A longitudinal study is needed to confirm these findings.

Review of Q-FAST interactive testing system.

The administration and scoring of paper and pencil measures present a host of logistical problems to clinicians, researchers and educators who rely heavily on these techniques. In addition to the expense of producing and reproducing these materials, the completed measures must be scored, the results must be reduced and recorded and the data must be analyzed. The introduction of human error at any of these steps may compromise the reliability of the obtained data and obstruct its valid interpretation. The Q-FAST computerized testing system is a software package which could improve the efficiency of collection, scoring and analysis of data obtained through such procedures.

Review of Papyrus bibliographic database software.

Papyrus is an inexpensive bibliographic database which provides some features not found in other similar packages. Its flexibility in handling references of many types and formats, its capacity for integration with manuscripts prepared with word processors, its capacity for importing references from national databases and its ability to perform microcosmic literature searches are attractive features. Because Papyrus has tackled a complex task, mastery of the intricacies of the program may present a substantial challenge to novice computer users. Although the manipulation of an existing customized bibliographic database would seem to be attractive for any researcher or author who prepares manuscripts for publication, the optimal use of the program also requires an extensive commitment of time and labor for the initial entry of all pertinent references into the database. While this could be accomplished gradually in conjunction with the preparation of individual manuscripts, the creation of a complete file of references could require hundreds of hours of labor. Individual authors, as well as larger research groups, should be prepared for this type of commitment before acquiring the Papyrus system.

Review of Survware from CompuStat software.

Survware is a simple program which permits the user to analyze the responses from multiple choice questionnaires and surveys of 2-50 questions. It is inexpensive when compared with a complete statistical package, but the limitation to frequency data may result in the need to purchase additional software. This program is most likely to be useful to users who regularly collect survey data and who do not need inferential statistical analysis of those data.