Checklists for Assessing Skills of Children With Type 1 Diabetes on Insulin Injection Technique.

BACKGROUND: School-aged children often participate in type 1 diabetes (T1D) self-care tasks. Despite widespread discussion about the importance of developing self-care skills in childhood, few explain how the health care team should assess the skills of children with T1D when performing insulin injections. OBJECTIVE: We sought to assess content validity evidence in two checklists regarding injection technique performed by children. METHODS: Two checklists were designed based on a systematic review of the insulin injection technique. Experts in pediatric diabetes, health literacy, and diabetes education assessed the checklists regarding their clarity, objectivity, and relevance. Content validity was assessed using the content validity ratio (CVR). RESULTS: Eleven providers (72% nurses or physicians, professional experience 19.4 ± 10.1 years, 45% of specialists in endocrinology, and 18% in pediatrics) participated in the assessment. Experts considered items containing the word homogeneity inappropriate. Items related to the needle insertion angle and the skin fold did not reach the CVR critical value. The final version of the checklist for syringe injection comprised 22 items with CVR = 0.91, and the checklist for pen injection comprised 18 items with CVR = 0.87. CONCLUSIONS: The checklists presented clear, objective, and relevant content that assesses the skills of children with T1D for insulin injection. The checklists formally present the order of the technique and all the steps for insulin injection and allow a quantitative assessment of the operational skills of children. The developed instruments offer providers the possibility of continuous assessment of the progress of the pediatric clientele until they reach independence in diabetes self-care.

Ethical challenges experienced by clinical research nurses:: A qualitative study.

BACKGROUND:: Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives (to implement research protocols and advance science), setting (research facilities), and nature of the nurse-participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility. Little is known about whether research nurses experience unique ethical challenges distinct from those experienced by nurses in traditional patient-care settings. RESEARCH OBJECTIVES:: The purpose of the study was to describe the nature of ethical challenges experienced by clinical research nurses within the context of their practice. RESEARCH DESIGN:: The study utilized a qualitative descriptive design with individual interviews. PARTICIPANTS AND RESEARCH CONTEXT:: Participating nurses (N = 12) self-identified as having experienced ethical challenges during screening. The majority were Caucasian (90%), female (83%), and worked in outpatient settings (67%). Approximately 50% had > 10 years of research experience. ETHICAL CONSIDERATIONS:: The human subjects review board approved the study. Written informed consent was obtained. FINDINGS:: Predominant themes were revealed: (1) the inability to provide a probable good, or/do no harm, and (2) dual obligations (identity as a nurse vs a research nurse). The following patterns and subthemes emerged: conflicted allegiances between protocol implementation, needs of the participant, desire to advance science, and tension between the nurse-patient therapeutic relationship versus the research relationship. DISCUSSION:: Participants described ethical challenges specific to the research role. The issues are central to the nurse-participant relationship, patient advocacy, the nurse's role in implementing protocols, and/or advancing science. CONCLUSION:: Ethical challenges related to the specialized role of clinical research nurses were identified. More research is warranted to fully understand their nature and frequency and to identify support systems for resolution.

Parental Characteristics Associated With Outcomes in Youth With Type 2 Diabetes: Results From the TODAY Clinical Trial.

OBJECTIVE: This study examined parental factors associated with outcomes of youth in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial. RESEARCH DESIGN AND METHODS: Of 699 youth with type 2 diabetes in the TODAY cohort, 623 (89.1%) had a parent participate and provide data at baseline, including weight, HbA1c, blood pressure, symptoms of depression, binge eating (BE), and medical history. Youth were followed 2-6.5 years. Data were analyzed using regression models and survival curve methods. RESULTS: Parental diabetes (43.6% of parents) was associated with higher baseline HbA1c (P < 0.0001) and failure of youths to maintain glycemic control on study treatment (53.6% vs. 38.2% failure rate among those without a diabetic parent, P = 0.0002). Parental hypertension (40.6% of parents) was associated with hypertension in youth during TODAY (40.4% vs. 27.4% of youth with and without parental hypertension had hypertension, P = 0.0008) and with higher youth baseline BMI z scores (P = 0.0038). Parents had a mean baseline BMI of 33.6 kg/m(2). Parental obesity (BMI >30 kg/m(2)) was associated with higher baseline BMI z scores in the youth (P < 0.0001). Depressive symptoms in parents (20.6% of parents) were related to youth depressive symptoms at baseline only (P = 0.0430); subclinical BE in parents was related to the presence of subclinical BE (P = 0.0354) and depressive symptoms (P = 0.0326) in youth throughout the study period. CONCLUSIONS: Parental diabetes and hypertension were associated with lack of glycemic control, hypertension, and higher BMI z scores in youth. Further research is needed to better understand and address parental biological and behavioral factors to improve youth health outcomes.

Treatment recommendations following 3-day masked continuous glucose monitoring (CGM) in youth with type 1 diabetes.

Glycemic control remains suboptimal in youth with type 1 diabetes. Retrospective continuous glucose monitoring (CGM) has demonstrated utility in fine-tuning diabetes management by detecting postprandial hyperglycemia and hypoglycemia. In this study, we explored the process of 3-day masked CGM use, subsequent treatment recommendations, and impact on A1c in a clinic-based sample of youth with type 1 diabetes. Over 2 years, 122 youth were referred for masked CGM. Patients/families completed a diary of blood glucose levels, insulin doses, food intake, and exercise during CGM use. A1c was assessed pre- and 2-3 months post-CGM. Treatment recommendations were formulated using data from CGM reports and diaries. Mean age was 14.3 ± 3.9 years, diabetes duration was 7.5 ± 4.7 years, and A1c was 8.5 ± 1.1% (69 ± 12 mmol/mol); 61% were pump-treated. Patients received an average of 3.1 ± 1.1 treatment recommendations following review of the CGM report. Most (80%) received reinforcement of the importance of preprandial bolusing; 37% received a recommendation regarding advanced insulin management (use of combination boluses/attend to active insulin). Receipt of the latter recommendation was related to A1c improvement ≥0.5% (OR: 4.0, P < .001). Masked CGM offers opportunities to guide advanced insulin management (by injection or pump), which may yield A1c improvements in youth with type 1 diabetes.

Learning needs of youth with type 2 diabetes.

PURPOSE: The purpose of this study was to examine reports of diabetes learning needs by youth with type 2 diabetes and their family support person (FSP) and to examine correlations of these perceptions with demographic variables. METHODS: Data were analyzed from the Participant Needs Assessment (PNA), a routinely self-administered questionnaire designed to assess learning needs, in 191 youth (mean age = 14.0 ± 1.9 years, duration 8.78 ± 6.30 months; 36% black, non-Hispanic; 40% Hispanic; 20% white) enrolled in the TODAY (Treatment Options for Type 2 Diabetes in Adolescents and Youth) study. Youth and their FSPs completed the PNA at scheduled study visits, rating their learning needs on a 5-point scale, with higher scores indicating higher needs. Paired t tests and ANOVA were used. RESULTS: There were no differences in reported learning needs by gender, although scores on the Teen Issues scale approached significance, with girls reporting higher needs than boys. Youth and FSPs were similar on their reports of needs on 3 scales (Ordinary Day, Nutrition, and Living With Diabetes), but youth reported higher needs than FSPs on Focus and Teen Issues. Controlling for duration of diabetes, these differences between youth and FSPs persisted. In general, learning needs for both youth and FSPs decreased over time. CONCLUSIONS: Youth with type 2 diabetes and their FSPs have high levels of ongoing learning needs despite completion of a standard diabetes education program. Continued assessment of learning needs, follow-up education, and behavioral approaches are warranted for these high-risk youth.

Sedentary behavior and physical activity in youth with recent onset of type 2 diabetes.

OBJECTIVE: With the rise of type 2 diabetes in youth, it is critical to investigate factors such as physical activity (PA) and time spent sedentary that may be contributing to this public health problem. This article describes PA and sedentary time in a large cohort of youth with type 2 diabetes and compares these levels with other large-scale investigations. METHODS: The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) trial is a study in 699 youth, recruited from 15 US clinical centers, aged 10 to 17 years with <2 years of type 2 diabetes and a BMI ≥85th percentile. RESULTS: In comparison with the subset of the NHANES cohort who were obese (BMI ≥95th percentile), TODAY youth spent significantly more time being sedentary (difference averaging 56 minutes per day; P < .001) as assessed by accelerometry. Although moderate to vigorous activity levels in both obese cohorts for all age groups were exceptionally low, younger TODAY boys were still significantly less active than similarly aged NHANES youth. Comparisons between the TODAY girls and other investigations suggest that the TODAY girls also had relatively lower PA and fitness levels. CONCLUSIONS: Adolescents with type 2 diabetes from the large TODAY cohort appear to be less physically active and tend to spend more time being sedentary than similarly aged youth without diabetes identified from other large national investigations. Treatment efforts in adolescents with type 2 diabetes should include decreasing sitting along with efforts to increase PA levels.

Self-reported dietary intake of youth with recent onset of type 2 diabetes: results from the TODAY study.

Despite the widely recognized importance of diet in managing diabetes, few studies have documented usual dietary intake in young people with type 2 diabetes. The objectives of our study were to assess dietary intake among a large, ethnically diverse cohort of young people with type 2 diabetes and compare intake to current recommendations. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study is a multicenter randomized clinical trial of 699 youth aged 10 to 17 years. At baseline, following a run-in period that included standard diabetes education, diet was assessed using a food frequency questionnaire between 2004 and 2009. Analysis of variance and nonparametric tests were used to compare mean and median nutrient intakes; logistic regression was used to compare the odds of meeting predefined dietary intake recommendation cutpoints between subgroups of age, sex, and race-ethnicity. Percent of energy from saturated fat was consistently 13% to 14% across all subgroups-substantially exceeding national recommendations. Overall, only 12% of youth met Healthy People 2010 guidelines for intake of <10% of energy from saturated fat and only 1% of youth met American Diabetes Association recommendations for intake of <7% of energy from saturated fat. Dietary intake fell substantially below other Healthy People 2010 targets; only 3% met calcium intake goals, 11% met fruit consumption goals, 5% met vegetable consumption goals, and 67% met grain intake goals. Overall, dietary intake in this large cohort of young people with type 2 diabetes fell substantially short of recommendations, in ways that were consistent by sex, age, and race-ethnicity. The data suggest a critical need for better approaches to improve dietary intake of these young people.

Collaborative Staffing Model for Multiple Sites: Reducing the challenges of study coordination in complex, multi-site clinical trials.

The implementation of complex, multi-site clinical trials presents challenges that make recruitment efforts, participant follow-up, and organization of staff critical to the success of the overall outcome. This article describes a unique staffing model utilized by the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) study, an NIH (National Institutes of Health) sponsored trial designed to explore treatment options for type 2 diabetes in youth. At each study center, the program coordinator (PC) and diabetes educator (DE) work together to implement the study protocol. A staffing model that provides this type of mutual support for two key members of the study team may decrease the burden customarily encountered solely by the PC in complex trials, and furthermore allows for cross-coverage and flexibility. To determine the degree of overlap and task sharing between the PC and DE across study sites, a self-administered survey was distributed to all PCs and DEs. Survey results as well as specific examples demonstrating an effective collaborative approach by front-line study personnel in managing various challenges encountered in study implementation are included.

Impact of a preconception counseling program for teens with type 1 diabetes (READY-Girls) on patient-provider interaction, resource utilization, and cost.

OBJECTIVE: To evaluate the impact of a preconception counseling program tailored for teens with type 1 diabetes on cognitive, psychosocial, and behavioral outcomes and to assess its cost-effectiveness. RESEARCH DESIGN AND METHODS: A total of 88 teens with type 1 diabetes from two sites were randomized into the READY-Girls (Reproductive-health Education and Awareness of Diabetes in Youth for Girls) intervention (IG) (n = 43) or standard care (SC) (n = 45) groups. During three diabetes clinic visits, IG subjects viewed a two-part CD-ROM, read a book, and met with a nurse. Program effectiveness was measured by knowledge, attitudes, intentions, and behaviors regarding diabetes, pregnancy, sexuality, and preconception counseling. Assessments occurred at baseline, before and after viewing program materials, and at 9 months. Economic analyses included an assessment of resource utilization, direct medical costs, and a break-even cost analysis. RESULTS: Age range was 13.2-19.7 years (mean +/- SD 16.7 +/- 1.7 years); 6% (n = 5) were African American, and 24% (n = 21) were sexually active. Compared with baseline and SC subjects, IG subjects demonstrated a significant group-by-time interaction for benefit and knowledge of preconception counseling and reproductive health: increasing immediately after the first visit (P < 0.001) and being sustained for 9 months (P < 0.05 benefits; P < 0.001 knowledge). For IG subjects, preconception counseling barriers decreased over time (P < 0.001), and intention and initiation of preconception counseling and reproductive health discussions increased (P < 0.001). Costs of adverse reproductive outcomes are high. Direct medical costs of READY-Girls were low. CONCLUSIONS: READY-Girls was beneficial and effects were sustained for at least 9 months. This low-cost self-instructional program can potentially empower young women with type 1 diabetes to make well-informed reproductive health choices, adding little time burden or cost to their diabetes management.

Factors predictive of use and of benefit from continuous glucose monitoring in type 1 diabetes.

OBJECTIVE: To evaluate factors associated with successful use of continuous glucose monitoring (CGM) among participants with intensively treated type 1 diabetes in the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Randomized Clinical Trial. RESEARCH DESIGN AND METHODS: The 232 participants randomly assigned to the CGM group (165 with baseline A1C >or=7.0% and 67 with A1C <7.0%) were asked to use CGM on a daily basis. The associations of baseline factors and early CGM use with CGM use >or=6 days/week in the 6th month and with change in A1C from baseline to 6 months were evaluated in regression models. RESULTS: The only baseline factors found to be associated with greater CGM use in month 6 were age >or=25 years (P < 0.001) and more frequent self-reported prestudy blood glucose meter measurements per day (P < 0.001). CGM use and the percentage of CGM glucose values between 71 and 180 mg/dl during the 1st month were predictive of CGM use in month 6 (P < 0.001 and P = 0.002, respectively). More frequent CGM use was associated with a greater reduction in A1C from baseline to 6 months (P < 0.001), a finding present in all age-groups. CONCLUSIONS: After 6 months, near-daily CGM use is more frequent in intensively treated adults with type 1 diabetes than in children and adolescents, although in all age-groups near-daily CGM use is associated with a similar reduction in A1C. Frequency of blood glucose meter monitoring and initial CGM use may help predict the likelihood of long-term CGM benefit in intensively treated patients with type 1 diabetes of all ages.

The impact of physiological, therapeutic and psychosocial variables on glycemic control in youth with type 1 diabetes mellitus.

OBJECTIVE: Intensive management of type 1 diabetes mellitus (DM1) in youth is challenging. We evaluated the relative impact of variables related to DM1 among groups of pre/early pubertal, midpubertal and postpubertal youths with DM1. METHODS: In this cross-sectional study of 153 youth with DM1, we ascertained Tanner stage, insulin dose and delivery modality (CSII vs MDI), daily blood glucose monitoring (BGM) frequency, and most recent hemoglobin A1c (HbA1c). We collected questionnaires from patients and their parents on diabetes-specific family conflict and family involvement in diabetes management tasks. We assessed predictors of glycemic control according to pubertal status. RESULTS: Insulin doses increased between pre/ early puberty and midpuberty (p <0.0001); daily BGM frequency (p = 0.02) and family involvement for DM management (p <0.001) were lowest in the postpubertal group. HbA1c was similar among all three puberty groups (8.4+/-1.4). Lower levels of child-reported DM-specific family conflict, more frequent BGM, and CSII use were significantly associated with lower HbA1c (R2 = 0.20, p <0.001). CONCLUSION: Although glycemic control was not significantly worse in midpubertal and post-pubertal patients, family involvement for DM management and adherence to BGM were lower in late adolescence. Interventions to optimize glycemic control may include minimizing DM-specific conflict, increasing BGM frequency, and implementing CSII use.