Impact of the use of Extended™ Wear Infusion sets on metabolic, ultrasound, and psychological outcomes in adults with type 1 diabetes using the Medtronic MiniMed 780G: a pilot randomized controlled trial.

INTRODUCTION In people with type 1 diabetes (PwT1DM), insulin infusion sets (IIS) are often regarded as the most fragile componentof insulin pump therapy. Standard IISs should be replaced every 2-3 days to prevent site complications and hyperglycemia. The objectiveof this randomized controlled trial was to evaluate the impact of 7-day Extended™ Wear Infusion sets (EIS; Medtronic MiniMed,Northridge, CA, USA) on metabolic, ultrasound (USG), and psychological outcomes in PwT1DM treated with the MiniMed 780G system(MM780G, Medtronic MiniMed, Northridge, CA, USA). MATERIAL AND

Methods

Fifteen participants in both the intervention (EIS) and control groups (standard IIS) completed the 3-month study.One participant in the control group did not attend the follow-up USG examination; however, all other clinical, continuous glucose monitoring(CGM), and questionnaire data were available and included in the analyses. In the intervention group, the mean age was 36.1 ± 10.7years, diabetes duration 20.3 ± 7.6 years, body mass index (BMI) 24.9 ± 4.0 kg/m², and glycated hemoglobin A1c (HbA1c) 6.7 ± 0.5%. There were no significant baseline differences between groups in age, diabetes duration, CGM indices, or HbA1c.

Results

Across the study period, no statistically significant differences were observed between the control and intervention groups with respect to the number of lipohypertrophic lesions, the volume of the largest lesion, HbA1c, CGM indices or insulin requirements. Inboth groups (with no between-group differences), World Health Organization (WHO) 5 scores indicated improvements in psychologicalwell-being. Notably, 80% of participants reported that EIS were more comfortable than standard sets, and 73.3% stated that the newinfusion sets met their expectations. Two-thirds of participants found that the new infusion sets made life easier.

Conclusions

These findings suggest that EIS are a safe and effective option for glycemic management in adults, without increasing lipohypertrophic lesions and with high patient acceptance.