A multi-center randomized controlled trial of the LenoMed ATA-I-1-0 insulin pump for the intensive treatment of diabetic patients.

Background: Continuous subcutaneous insulin infusion (CSII) is an effective method for managing diabetes. The aim of this study was to evaluate the efficacy and safety of the LenoMed ATA-I-1-0 insulin pump for the treatment of patients with type 1 and type 2 diabetes, compared to the Medtronic MMT-712 insulin pump.

Methods: A total of 120 subjects with diabetes needing insulin treatment were recruited, and 104 completed the trial. The intervention and control group used the LenoMed and Medtronic insulin pump, respectively. The primary outcome was a reduction in fasting plasma glucose. Secondary outcomes included blood glucose control at 7 time points (before and after each meal, and before sleep), hemoglobin A1c (HbA1c) levels at 1 time point, and accuracy and safety of the pumps.

Results: In the per protocol set of 104 subjects, a significant drop in fasting plasma glucose levels was observed for 98.0% subjects in the intervention group and 92.7% in the control group. There was no statistically significant difference between groups [5.23%; 95% confidence interval (CI): -2.69% -13.2%]. Compared to baseline, levels of blood glucose and HbA1c dropped (P<0.001) at a similar magnitude in both groups. The accuracy and alarm effectiveness was 100%. No adverse event or severe adverse event related to the medication occurred in the study.

Conclusions: The novel injection equipment, the LenoMed ATA-I-1-0 insulin pump, demonstrated efficacy and a good safety profile, and was not inferior to the widely used Medtronic MMT-712 insulin pump. Thus, our study suggests that the LenoMed ATA-I-1-0 insulin pump can be widely used in clinical practice.