A novel duodenal-release formulation of caraway oil and L-menthol is a safe, effective and well tolerated therapy for functional dyspepsia.

BACKGROUND: A randomized, placebo-controlled clinical trial (FDREST) of a novel formulation of caraway oil and L-menthol (COLM-SST) demonstrated symptom relief in patients with functional dyspepsia (FD). Two follow-up studies were conducted to evaluate patient satisfaction, self-regulated dosing, and long-term safety data: FDACT, Functional Dyspepsia Adherence and Compliance Trial, and FDSU36, Functional Dyspepsia Safety Update at 36 months. METHODS: A patient reported outcomes (PRO) questionnaire was designed and distributed online to assess real-world satisfaction and dosing frequency of open-label COLM-SST in patients with FD. A separate study analyzing voluntary safety surveillance data evaluated the frequency and severity of reported adverse events (AEs). RESULTS: A total of 600 FD patients were enrolled in the PRO study. Ninety five percent of respondents reported a major or moderate improvement in their FD symptoms and 91.7% indicated a major or moderate improvement in quality of life (QOL) using COLM-SST. Between 1 and 4 capsules were consumed daily by 91.2% of respondents, with 56.2% taking them before meals. Symptom relief was rapid, with 86.4% of respondents indicating relief within 2 h of taking COLM-SST. Few adverse events (AEs) were reported (0.0187%) by patients using COLM-SST. No serious AEs were identified. CONCLUSION: COLM-SST is safe, well tolerated, and provides rapid relief of FD symptoms. These findings, demonstrated in the FDREST trial, were further supported by a large prospective PRO study evaluating self-regulated dosing frequency, symptom improvement, and QOL. COLM-SST was well-tolerated based on review of AE data at 36 months.

Assessing regimen adherence of adolescents with type 1 diabetes.

OBJECTIVE: The purpose of this study is to evaluate two updated measures of diabetes regimen adherence. The Diabetes Self-Management Profile (DSMP) is a widely used, structured interview. Limitations include a substantial interviewer and respondent time burden and the need for well-trained interviewers to use appropriate prompts and score the open-ended responses. The Diabetes Behavior Rating Scale (DBRS) is a self-administered, fixed-choice survey. RESEARCH DESIGN AND METHODS: Both measures were administered to 146 youth with type 1 diabetes (aged 11-18 years) and their parents. Items were added to the DBRS to allow for both flexible and conventional regimens, and the DSMP was modified to use standardized wording across items, accommodate flexible regimens, and permit administration by nonmedical interviewers. RESULTS: Both measures had good evidence of internal consistency (for the DSMP: parent 0.75 and youth 0.70; for the DBRS: parent 0.84 and youth 0.84). Scores on the DSMP and the DBRS were significantly related (r = 0.72 for parents and 0.74 for youth). There was moderate agreement between parent and youth (DSMP, r = 0.51; DBRS, r = 0.48). The measures were correlated with HbA1c for both parent (DSMP, r = -0.35; DBRS, r = -0.35) and youth (DSMP, r = -0.36; DBRS, r = -0.34) reports. CONCLUSIONS: Both measures exhibit good psychometric properties and good criterion validity but varied in terms of respondent and interviewer burden, issues that should be considered in selecting assessment procedures.

Acceptability of lower glycemic index foods in the diabetes camp setting.

OBJECTIVE: To determine the acceptability of lower glycemic index (GI) foods served at diabetes camp. DESIGN: Crossover design of standard and lower GI menus. SETTING: Three consecutive 5-day diabetes camp sessions. PARTICIPANTS: 140 youth, age 7-16, with type 1 or 2 diabetes. INTERVENTION: A standard camp cycle menu was reformulated to include 2 1/2 days of standard foods and 2 1/2 days of lower GI foods. MAIN OUTCOME MEASURES: Youth provided satisfaction ratings after meals and snacks using measures designed for this study. Observations of food consumption were conducted on a random sample of youth for each meal. ANALYSIS: Descriptive analyses and t-tests were conducted to assess differences in satisfaction with and consumption of standard and lower GI foods. RESULTS: Lower GI foods served at dinner and for snacks received satisfaction ratings equal to standard foods (dinner: 3.68 lower GI versus 3.79 standard, P = .30; snacks: 3.74 lower GI versus 3.79 standard, P = .60). Lower GI foods served at breakfast and lunch received lower, though very acceptable, ratings (breakfast: 3.76 lower GI versus 4.04 standard, P < .01; lunch: 3.64 lower GI versus 3.88 standard, P = .01). Consumption of all meals was acceptable. No differences occurred in the frequency of high or low blood sugars between standard and lower GI days. CONCLUSIONS AND IMPLICATIONS: Higher quality carbohydrates may be provided to youth in institutional settings while maintaining sufficient levels of acceptability; specific findings are instructive for designing efforts to increase their consumption.

Long-term maintenance of treatment outcomes: diabetes personal trainer intervention for youth with type 1 diabetes.

OBJECTIVE: To describe a 2-year follow-up of A1C outcomes of a self-regulation intervention for youth with type 1 diabetes. RESEARCH DESIGN AND METHODS: A total of 81 youths with type 1 diabetes ages 11-16 years were randomized to usual care versus a diabetes personal trainer intervention consisting of six self-monitoring, goal-setting, and problem-solving sessions with trained nonprofessionals. A1C data were obtained from medical records 2 years postintervention, and ANCOVA adjusting for age and baseline A1C was conducted. RESULTS: An overall intervention effect on A1C (8.93% control vs. 8.43% intervention; F = 8.24, P = 0.05) and a significant intervention-by-age interaction (F = 9.88; P = 0.002) were observed, indicating a greater effect among older than younger youths. Subgroup analyses demonstrated no treatment group differences among pre-/early adolescents but a significant difference in A1C among middle adolescents (9.61% control vs. 8.46% intervention; F = 7.20, P = 0.011). CONCLUSIONS: Findings indicate maintenance of intervention effects on A1C observed at 1-year follow-up.

Diabetes personal trainer outcomes: short-term and 1-year outcomes of a diabetes personal trainer intervention among youth with type 1 diabetes.

OBJECTIVE: To assess the social-cognitive, behavioral, and physiological outcomes of a self-management intervention for youth with type 1 diabetes. RESEARCH DESIGN AND METHODS: A total of 81 youth with type 1 diabetes aged 11-16 years were randomized to usual care versus a "diabetes personal trainer" intervention, consisting of six self-monitoring, goal-setting, and problem-solving sessions with trained nonprofessionals. Assessments were completed at baseline and multiple follow-up intervals. A1C data were obtained from medical records. ANCOVA adjusting for age and baseline values were conducted for each outcome. RESULTS: At both short-term and 1-year follow-up, there was a trend for an overall intervention effect on A1C (short-term F = 3.71, P = 0.06; 1-year F = 3.79, P = 0.06) and a significant intervention-by-age interaction, indicating a great effect among older than younger youth (short-term F = 4.78, P = 0.03; 1-year F = 4.53, P = 0.04). Subgroup analyses demonstrated no treatment group difference among younger youth but a significant difference among the older youth. No treatment group differences in parent or youth report of adherence were observed. CONCLUSIONS: The diabetes personal trainer intervention demonstrated significant effects in A1C among middle adolescents.

Identification of distinct self-management styles of adolescents with type 1 diabetes.

OBJECTIVE: Using a profile-based approach to the assessment of diabetes management, the purpose of this study was to identify and evaluate an empirically derived classification system of distinct self-management styles. RESEARCH DESIGN AND METHODS: Youth with type 1 diabetes (n = 156) aged 10-16 years and their parents were administered a modified version of the Diabetes Self-Management Profile (DSMP). Cluster analyses were performed independently on parent and youth report forms to categorize patients based on their patterns of scores in five diabetes self-management areas. RESULTS: Cluster analyses revealed three self-management styles that emerged from both youth and parent report: a "methodical style" (33%) with an emphasis on careful meal planning and correct insulin administration; an "adaptive style" (46%), characterized by high rates of blood glucose testing, exercise, and self-care adjustments; and an "inadequate style" (21%) with moderate rates of self-care adjustments and otherwise low DSMP scores. Convergence between parent and youth report classifications was moderate (Cohen's kappa = 0.47, P < 0.0001). A1C was 1.6% higher in the inadequate style group than in both other groups (P < 0.0001), and the classification significantly accounted for differences in A1C above what was explained by an overall DSMP score. CONCLUSIONS: The findings provide support for recognizing subgroups of patients with unique multidimensional patterns of self-care behaviors. The assessment of self-management styles may prove useful for customized treatments that are targeted directly to the patients' needs.