Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211536
Status:
COMPLETED
Last Update Posted:
2011-09-21
First Post:
2005-09-13
Brief Title:
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
Sponsor:
Medtronic Diabetes
Organization:
Medtronic Diabetes
Study Overview
Official Title:
A Randomized Active Control Multi-Center Study Comparing the Effect of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration on Glycemic Control and the Frequency of Severe Hypoglycemia
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIP310
Brief Summary:
The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum abdomenby an implantable pump in Type 1 diabetics
Detailed Description:
Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects as demonstrated in numerous European studies Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia This study is aimed at comparing the efficacy of intraperitoneal IP insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None