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Individualized insulin strategies may improve glycemic control in pediatric T1DM with exogenous insulin antibody syndrome

Individualized insulin strategies may improve glycemic control in pediatric T1DM with exogenous insu…
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Key Takeaway
Consider individualized insulin optimization for pediatric T1DM with EIAS; MMF may be transiently helpful in refractory cases.

This retrospective case series described clinical characteristics, diagnostic strategies, and therapeutic outcomes in 5 pediatric patients with type 1 diabetes mellitus complicated by exogenous insulin antibody syndrome (EIAS), representing 0.4% of 1,245 T1DM patients evaluated at a single center. Individualized treatment strategies included ultra-rapid insulin with closed-loop pump, regular insulin every 4 hours, switching from pump to multiple daily injections, aspart plus glargine, and mycophenolate mofetil (MMF) for refractory cases. No comparator group was reported.

Regarding glycemic outcomes, individualized insulin optimization improved time in range (TIR) to >70% in 4 of the 5 patients. In the single refractory case treated with MMF, TIR improved to >70% and time below range (TBR) was 30% after 3 months of treatment. However, glycemic instability recurred rapidly within 4 weeks after MMF discontinuation. The study did not report specific effect sizes, p-values, or confidence intervals for these outcomes.

Safety and tolerability data were not reported. Key limitations include the observational nature of the study, the very small sample size (n=5), the absence of a control group, and lack of blinding. The authors note that continuous glucose monitoring metrics (TIR, TBR, coefficient of variation) are essential for assessment in this population, as HbA1c may not reflect glycemic variability. For clinical practice, this evidence suggests that individualized insulin optimization may improve TIR in most pediatric patients with T1DM and EIAS, while MMF may represent a potential option for refractory cases, though its effect appears transient upon discontinuation. Causal inferences cannot be drawn from this design, and findings should be considered hypothesis-generating.

Study Details

Study typeCohort
EvidenceLevel 3
PublishedMar 2026
View Original Abstract ↓
ObjectiveThis study investigates the clinical characteristics, diagnostic strategies, and therapeutic outcomes of individualized treatment for children with type 1 diabetes mellitus (T1DM) complicated by exogenous insulin antibody syndrome (EIAS).MethodsA retrospective case series study was conducted on five pediatric patients diagnosed with T1DM+EIAS at a single center between January 2016 and January 2026. Among 1,245 T1DM patients evaluated, 5 (0.4%) met EIAS diagnostic criteria. Data included demographics, clinical manifestations, laboratory findings (insulin antibodies [IA], C-peptide, continuous glucose monitoring [CGM]), treatment regimens, and outcomes. Longitudinal autoantibody profiles, thyroid function, immune parameters, and cytokines were assessed at four time points. A narrative review of published EIAS cases was conducted following PRISMA guidelines.ResultsCase 1 achieved glycemic stability using ultra-rapid insulin with closed-loop pump (6-hour active insulin duration). Case 2, a 1-year-old infant, required regular insulin every 4 hours (six doses daily). Case 3 switched from pump to conventional multiple daily injections (MDI) with 4–6 daily injections. Case 4 used 4–6 daily aspart doses plus once-daily glargine. All four achieved TIR >70%. Case 5, with refractory disease and IA titer of 33.40 COI, received mycophenolate mofetil (MMF) 600–1,000 mg/m²/day. After 3 months, TIR improved to >70%, TBR 30%. MMF discontinuation resulted in rapid recurrence of instability within 4 weeks.ConclusionEIAS is a rare cause of severe glycemic dysregulation in pediatric T1DM. CGM metrics (TIR, TBR, CV) are essential for assessment, as HbA1c may not reflect glycemic variability. Individualized insulin optimization improves TIR in most patients. For refractory cases, MMF may offer a potential therapeutic option. Due to the observational nature, small sample size (n=5), absence of a control group, and lack of blinding, these findings should be considered hypothesis-generating. Causal inferences cannot be drawn, and the results require validation in prospective, multicenter, controlled studies.
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