FreeStyle Navigator Continuous Glucose Monitoring System Use in Children With Type 1 Diabetes Using Glargine-Based Multiple Daily Dose Regimens

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Abstract
In a previous pilot study of the FreeStyle Navigator Continuous Glucose Monitoring System, hereafter referred to as “Navigator,” in 30 children and adolescents with type 1 diabetes using insulin pumps, we found that Navigator use averaged >130 h per week over 13 weeks and mean A1C level dropped from 7.1 ± 0.6 to 6.8 ± 0.7% ( P = 0.02) (1). The current study evaluated whether the Navigator was similarly tolerated over 13 weeks in 27 children aged 4–17 years with type 1 diabetes using glargine-based, multiple daily injection(MDI) insulin regimens. Subjects averaged >100 h/week of Navigator use. Mean A1C level fell from 7.9 ± 1.0% at baseline to 7.3 ± 0.9% at 13 weeks ( P = 0.004). High satisfaction with the Navigator was reported on the Continuous Glucose Monitor Satisfaction Scale. These encouraging pilot study results support the inclusion of MDI users in longer-term randomized clinical trials of continuous glucose monitors. Institutional review boards at each of the Diabetes Research in Children Network (DirecNet) centers approved the study protocol and consent/assent forms. Research methods were virtually identical to those employed in our previous Navigator (Abbott Diabetes Care; Alameda, CA) study (1) except that all subjects were treated with glargine-based MDI treatment. Other eligibility requirements were as follows: subjects must 1 ) be aged 3–17 years, 2 ) have type 1 diabetes for a duration ≥1 year, 3 ) have access to a home computer equipped with E-mail, and 4 ) have a parent/older subject who comprehended English. Subjects were excluded for asthma, cystic fibrosis, psychiatric disorder, and use of glucocorticoids. Subjects were selected for participation from the existing patient population at each center. There was a 1-week run-in period during which Navigator use was blinded to collect baseline glucose data, followed by unblinded home use for 3 months. To blind subjects to the results …