SAT-216 - I-Port Insulin Administration System in Children and Youth with Type 1 Diabetes: Randomized Controlled Trial

Background
Early management of type 1 diabetes (T1D) in the pediatric population involves multiple daily insulin injections, which are often painful and pose significant adherence challenges. The i-Port system (Medtronic) allows short and long-acting insulin delivery through the port for 72 hours after insertion with a single injection. Data on the efficacy and safety of i-Port use in the pediatric population are limited.

Objective
To evaluate i-Port system's efficacy, safety, and quality of life (QOL) compared to standard insulin administration by multiple daily injections (MDI) in children and adolescents with T1D.

Methods
In this open-label, randomized controlled clinical trial, patients aged 1-18 years who required at least 3 daily insulin injections, but were not yet eligible for insulin pump therapy or chose not to use it, were recruited from four academic medical centers in Israel. Participants were randomly allocated to either the i-Port group or the control group, which received MDI, and were followed prospectively for 2 months. All patients were instructed and encouraged to wear a continuous glucose monitoring (CGM) system. Primary outcomes included differences in the number and dose of daily insulin administrations, glycemic control parameters, QOL questionnaire scores, and adverse events between the i-Port and control groups.

Results
Of the 43 participants randomized, 31 were assigned to the i-Port group and 12 to the control group; 30 (69.7%) completed the study (22 from the i-Port group and 8 from the control group). Median age of participants was 11.2 years (IQR 9.5, 13.9), median diabetes duration at i-Port initiation was 1 month (IQR 0.5, 7.5), and 70% had new-onset T1D. No statistically significant differences were found in the number of daily insulin administrations (p=0.560), total daily short-acting insulin dose/kg (p=0.615), total daily long-acting insulin dose/kg (p=0.475), HbA1C (p=0.555), and QOL questionnaire scores (p=0.836) between the i-Port and control groups. However, relative reduction in mean glucose, measured by (baseline mean glucose-end mean glucose)/baseline mean glucose, was found to be significantly higher in the i-Port group compared to the controls (p=0.036). Rate of skin reactions did not differ between the groups (p=0.369); 1 patient from the i-Port group had a DKA episode, and 6 patients had port failure. By the end of follow-up, 22.7% of participants from the i-Port group and 12.5% from the control group chose to use the i-Port system and paid for it out of pocket.

Conclusions
i-Port use is safe and effective in pediatric patients with new-onset T1D and those with longer disease duration who declined an insulin pump. Its use was associated with a greater relative reduction in mean glucose compared to MDI.

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