Abstract

Objective- Continuous intraperitoneal insulin infusion (CIPII) with an implantable pump has been available for the past 25 years. CIPII, with its specific pharmacodynamic properties, may be a viable treatment alternative to improve glycemic control in patients with type 1 diabetes for whom other therapies have failed. There have been few studies in which CIPII was compared with subcutaneous (SC) insulin treatment for patients with type 1 diabetes with poor glycemic control.

Research Design and Methods- In an open-label, prospective, crossover, randomized, 16-month study, the effects of CIPII and SC insulin were compared in 24 patients. The primary outcome measure was the incidence of hypoglycemia. Secondary outcome measures were glycated hemoglobin (HbA_1c), and glucose profile, including time in euglycemia, as measured by continuous glucose monitoring.

Results- The incidence of grade 1 hypoglycemic events was 4.0±2.6 per week with SC insulin compared with 3.5±2.3 per week during CIPII (p=0.13). The absolute mean difference in HbA_1c with CIPII as compared with SC treatment was −0.76% (95% CI:−1.41,−0.11) (p=0.03). Baseline time spent in euglycemia was 45.2±12.6% and increased 10.9% (95%CI:4.6,17.3) with CIPII compared to SC treatment (absolute value; p=0.003). There were no differences in the occurrence rate for severe hypoglycemic events, daily insulin use, or BMI. No pump or catheter malfunction was observed during the study.

Conclusions- Though we did not observe a significant reduction in hypoglycemic events, improved glycemic control was achieved with the use of CIPII. We saw a 0.8% decrease in HbA_1c and an 11% increase in the time spent in euglycemia.