ArticleClinical medicine insights. Endocrinology and diabetes2026
Efficacy and Safety of an Insulin Patch Pump Compared to Multiple Daily Injections in Pediatric Patients With Diabetes: A Randomized, Open-Label, Crossover, Non-Inferiority Clinical Trial.
Article in Clinical medicine insights. Endocrinology and diabetes, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Insulin patch pumps offer advantages over multiple daily injections (MDI) for pediatric diabetes, but randomized trial evidence in Chinese children remains limited. Objectives: To evaluate the efficacy and safety of a tubeless insulin patch pump (Equil™) compared with MDI in children and adolescents with diabetes. Methods: This multicenter, open-label, randomized, crossover, non-inferiority trial was conducted at seven pediatric endocrinology centers in China (September 2021 - October 2022). Patients aged 3-17 years with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) were randomized 1:1 to receive continuous subcutaneous insulin infusion (CSII) via Equil™ or MDI via insulin pen for 5 days, followed by crossover. The primary outcome was mean blood glucose (MBG). Non-inferiority margin was pre-specified as 0.386 mmol/L. Secondary outcomes included glycemic variability (standard deviation of blood glucose, SDBG), glycated albumin (GA), total daily insulin dose (TDD), hypoglycemia frequency, and adverse events. Patient satisfaction was assessed using a study-specific 11-item questionnaire. Results: Of 74 enrolled patients, 72 (97.3%) completed the study. CSII demonstrated non-inferiority to MDI for MBG (8.43±1.88 mmol/L, n=74, vs 9.00±2.04 mmol/L, n=72); mean difference -0.606 mmol/L; 95% CI -0.988 to -0.223; upper CI limit -0.223 < non-inferiority margin 0.386. No significant differences were observed for secondary outcomes (SDBG: 3.019 vs 3.357; GA change: 2.52±3.03% vs 2.02±3.25%, p=0.184; TDD: 132.17±78.43 vs 147.52±91.59 IU, p=0.159; hypoglycemia events: 114 vs 106). Adverse event rates were similar (75.7% vs 69.4%, p=0.399); no serious adverse events occurred. Patient satisfaction was significantly higher with CSII (total score 21.03±4.47 vs 22.00±3.99; mean difference -0.97, 95% CI -1.75 to -0.19; p=0.015), with 68.1% of patients preferring the patch pump. Conclusion: The Equil™ patch pump is non-inferior to MDI in terms of glycemic control and safety for pediatric diabetes patients, with higher patient satisfaction. These findings support the patch pump as an effective alternative for children and adolescents requiring exogenous insulin therapy.
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