Predictors of response to insulin therapy in youth with poorly-controlled type 2 diabetes in the TODAY trial.

OBJECTIVE: To understand the factors associated with glycemic control after starting insulin in youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with metformin alone, metformin + rosiglitazone or metformin + lifestyle in the TODAY study. METHODS: Change in HbA1c after add-on insulin therapy and the factors predictive of glycemic response were evaluated. At 1-year postinsulin initiation, 253 youth had a mean of 3.9 ± 1.0 visits since the time of insulin initiation. Participants were divided into three groups according to glycemic control: consistent decrease in HbA1c by ≥0.5%, change <0.5%, or consistent increase in HbA1c ≥0.5%, at 75% or more of the visits. RESULTS: Within 1-year postinsulin initiation, 33.2% of participants had a consistent HbA1c decrease of ≥0.5%, 46.2% changed HbA1c <0.5%, and 20.6% had an increase ≥0.5%. At randomization into TODAY and at time of insulin initiation, the three glycemia groups were similar in age, sex, race-ethnicity, pubertal stage, BMI z-score, diabetes duration, and insulin secretion indices. Consistent HbA1c improvement was associated with higher insulin sensitivity (1/fasting insulin) at randomization and at time of failure, higher adiponectin at randomization, and was not associated with indices of ß-cell function. CONCLUSIONS: Response to add-on insulin was highly variable among youth in TODAY. Greater insulin sensitivity and higher adiponectin concentrations at randomization were associated with improved glycemic control after initiation of insulin. Due to limited information on adherence to insulin injections, the roles of adherence to the prescribed insulin regimen or psychosocial factors are unknown.

PedsQL 3.2 Diabetes Module for Children, Adolescents, and Young Adults: Reliability and Validity in Type 1 Diabetes.

OBJECTIVE: The objective of the study was to report on the measurement properties of the revised and updated Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module for children, adolescents, and young adults with type 1 diabetes. RESEARCH DESIGN AND METHODS: The 33-item PedsQL 3.2 Diabetes Module and PedsQL Generic Core Scales were completed in a 10-site national field test study by 656 families of patients ages 2-25 years with type 1 diabetes. RESULTS: The 15-item Diabetes Symptoms Summary Score and 18-item Diabetes Management Summary Score were derived from the factor analysis of the items. The Diabetes Symptoms and Diabetes Management Summary Scores evidenced excellent reliability (patient self-report α = 0.88-0.90; parent proxy report α = 0.89-0.90). The Diabetes Symptoms and Diabetes Management Summary Scores demonstrated construct validity through medium to large effect size correlations with the Generic Core Scales Total Scale Score (r = 0.43-0.67, P < 0.001). HbA1c was significantly correlated with the Diabetes Symptoms and Diabetes Management Summary Scores (r = -0.21 to -0.29, P < 0.001). Minimal clinically important difference scores ranged from 5.05 to 5.55. CONCLUSIONS: The PedsQL 3.2 Diabetes Module Diabetes Symptoms and Diabetes Management Summary Scores demonstrated excellent measurement properties and may be useful as standardized patient-reported outcomes of diabetes symptoms and diabetes management in clinical research, clinical trials, and practice in children, adolescents, and young adults with type 1 diabetes.