Article

Evaluation of a combined blood glucose monitoring and gaming system (Didget®) for motivation in children, adolescents, and young adults with type 1 diabetes*

Pediatric Diabetes (Impact Factor: 2.08). 06/2011; DOI:10.1111/j.1399-5448.2011.00791.x

ABSTRACT Klingensmith GJ, Aisenberg J, Kaufman F, Halvorson M, Cruz E, Riordan ME, Varma C, Pardo S, Viggiani MT, Wallace JF, Schachner HC, Bailey T. Evaluation of a combined blood glucose monitoring and gaming system (Didget®) for motivation in children, adolescents, and young adults with type 1 diabetes.The purpose of this study was to assess the performance and acceptability of a blood glucose meter coupled with a gaming system for children, adolescents, and young adults with type 1 diabetes. During an in-clinic visit, duplicate blood samples were tested by subjects (N = 147; aged 5–24 yr) and health care providers (HCPs) to evaluate the accuracy and precision of the Didget® system. Subjects' meter results were compared against Yellow Springs Instruments (YSI) reference results and HCP results using least squares regression and error grid analyses. Precision was measured by average within-subject and within-HCP coefficient of variation (CV). During the home-use component of this study, subjects (n = 58) tested their blood glucose at least two to three times daily for 3–5 d to evaluate routine use of the system. Subjects' meter results showed significant correlations with both YSI (r2 = 0.94; p < 0.001 for regression slope) and HCP results (r2 = 0.96; p < 0.001). Average within-subject and within-HCP CVs were 5.9 and 7.2%, respectively. Overall satisfaction was assessed by subjects, their parents or guardians, and HCP surveys. Subject satisfaction with the Didget® system was good to excellent; most subjects found the system easy to use, motivating, and helpful for building good blood glucose monitoring habits. Most HCPs agreed that the system fulfilled a need in diabetes management. In conclusion, the Didget® system was precise and clinically accurate in the hands of children, adolescents, and young adults with type 1 diabetes.

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    ABSTRACT: This study evaluated the performance of the DIDGET® blood glucose monitoring system (BGMS) in the hands of its intended users: children, teens, and young adults with diabetes. Finger stick capillary blood samples were tested in duplicate by subjects (with parent/guardian assistance, if needed) and health care professionals using the DIDGET BGMS, and results were compared with those obtained using a Yellow Springs Instruments (YSI) glucose analyzer. Modified venous blood samples (i.e., glycolyzed or spiked with glucose) were used to analyze meter performance under extreme glucose concentrations. Accuracy was assessed using International Organization for Standardization (ISO) 15197:2003 guidelines (i.e., 95% of meter results within ±15 mg/dl or ±20% of reference values). A total of 123 subjects aged 4 to 24 years with type 1 or type 2 diabetes were enrolled. The DIDGET meter achieved accuracy according to ISO 15197:2003 criteria: >97% of meter results were within ±15 mg/dl or ±20% of reference values. Regression analyses showed a high degree of correlation between meter and YSI results: coefficient of determination (R(2)) = 98.2% for all samples combined and 97.2% for capillary samples only. Clinical accuracy for combined samples was demonstrated by Parkes consensus error grid analyses; 100% of meter results were in zone A (98.5%) or zone B (1.5%). There was no difference in performance or accuracy across age subsets. Hematocrit values did not affect meter blood glucose results. The DIDGET BGMS provided accurate test results across all age ranges in children, teens, and young adults with diabetes.
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