Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
|Diabetes Mellitus, Type 1||Device: MIP 2007C implantable insulin pump Device: continuous subcutaneous insulin infusion (CSII) or MDI||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Cross-Over Single Centre Study Comparing the Effects of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus Patients|
- incidence of hypoglycemia; data taken from patient diaries during either study arm.
- glycemic control; glycosylated hemoglobin (HbA1c) measurement at baseline, end of entry phase, start of both study arms, halfway through study arms, end of study arms.
- average daily insulin usage; as taken from patient diaries for both study arms
- frequency of adverse events; as taken from patient diaries for both study arms
- frequency of clinically significant abnormal laboratory values and device complications; as taken from patient diaries for both study arms
- Quality of life; score on a quality of life scale at baseline and end of either study arm
- Treatment satisfaction; score on treatment satisfaction scale at baseline and end of either study arm
- daily glucose excursions; measured with continuous glucose monitoring system (CGMS) at baseline, halfway through and at the end of both study arms
|Study Start Date:||February 2006|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Intraperitoneal insulin infusion by means of an implanted insulin pump
Device: MIP 2007C implantable insulin pump
Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c
Active Comparator: CSII/ MDI
Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII) or by multiple daily injections (MDI)
|Device: continuous subcutaneous insulin infusion (CSII) or MDI|
Various study data available suggest that intraperitoneal (IP) delivery of insulin in type 1 and type 2 diabetic subjects provides an appropriate therapy that allows subjects to achieve acceptable glycemic control without increasing the inherent risk of severe hypoglycemia observed when intensive insulin treatment is pursued. Up till now little research has been done to investigate the efficacy of intraperitoneal (IP) therapy compared to subcutaneous administration. In this study we aim for safety and non-inferiority or superiority for IP therapy concerning glycemic control with less episodes of hypoglycemia compared to intensive subcutaneous (SC) therapy in intermediate or poorly controlled Type 1 patients and/or patients with frequent severe hypoglycemic events.
Subjects will be randomized to insulin treatment using the Medtronic Minimed Implantable Pump or to subcutaneous insulin therapy during the first study arm. After the first arm of the study, subjects will be crossed over to the second arm and will receive the treatment whichever they had not received in the first treatment phase. Subjects with the MIP already implanted will retain the pump but will receive diluent intraperitoneally for the second study arm.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286962
|Zwolle, Netherlands, 8000 GM|
|Principal Investigator:||Henk J Bilo, MD, PhD||Isala Clinics, medical research foundation|