NCT01621308

Intraperitoneal vs Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

Intraperitoneal Insulin Administration as Alternative for Intensive Subcutaneous Insulin Therapy in Patients With Type 1 Diabetes Mellitus.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 190 (actual)
• Sponsor: Medical Research Foundation, The Netherlands · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Almost all patients with type 1 diabetes mellitus (T1DM) need insulin treatment permanently. For selected patients who are unable to achieve glycaemic targets with subcutaneous (SC) insulin treatment, continuous intraperitoneal (IP) insulin infusion is an third-line alternative. Previous studies demonstrate that continuous intraperitoneal insulin infusion (CIPII) using an implantable pump device improves glycaemic control and quality of life in patients with 'brittle' T1DM. Nevertheless, literature comparing IP and SC insulin treatment is scarce. The primary objective of this study is to compare the effects of IP insulin delivery to SC insulin delivery.The null hypothesis (H0) of the current study holds inferiority of CIPII compared to SC insulin regarding long-term glycaemic control. The alternative hypothesis (H1) is the inverse: CIPII is non-inferior to SC insulin. In summary, H0: CIPII is inferior to the SC insulin treatment H1: CIPII is not inferior to SC insulin treatment This is an investigator initiated, open label and prospective matched-control study with a non-inferiority design. The trial duration is 36 weeks and is conducted in a single-centre (Isala Clinics, Zwolle). If non-inferiority is established superiority analyses are performed.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Mode of insulin administration	There are no interventions in this observational study. Both treatment groups continue the mode of therapy the patient had before the start of the present study: continuous intraperitoneal insulin infusion with an implantable pump (MIP2007D) or subcutaneous insulin administration with multiple daily injections or continuous subcutaneous insulin infusion.

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-06-18
• Last updated: 2014-03-19

Locations

2 sites across 1 country: Netherlands