Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298740
Status:
COMPLETED
Last Update Posted:
2017-09-12
First Post:
2006-03-01
Brief Title:
Medtronic MiniMed Implantable Insulin Pump
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Reimplantation of Subjects With Implantable Insulin Pump Therapy
Status:
COMPLETED
Status Verified Date:
2017-09
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:
None
Brief Summary:
This research is being done to find out whether subjects previously treated with the implantable insulin pump IIP therapy and now taking insulin by injection will benefit from re-implantation of IIP The investigators will see if IIP causes more stable control of blood sugar with fewer highs and lows People with type 1 diabetes previously implanted with the MiniMed Implantable Pump MIP model 2000 at Johns Hopkins may join this study
Detailed Description:
If the participant joins the study and chooses to have a new pump implanted the study is expected to last 12-15 months for each participant and each participant will continue to be followed with 3-monthly refills and research visits for as long as the pump lasts until the participant chooses to withdraw until the FDA approves the pump for regular care or until the company stops supporting the pump During the first 12-15 months of the study there will be an estimated 13 clinic visits and one hospital stay for 2-3 days The data collection visits will take about 30 minutes and a continuous glucose monitor will be started The participants will have a brief visit 3-4 days later to drop off the monitor After this phase of the research the participants will still be cared for with the implanted pump having visits for refills and tests every 3 months This long-term follow up will last until the participants choose to withdraw the pump malfunctions the FDA approves the pump for regular care or the company no longer supports the pump If the participants are no longer taking part in the study the investigators will have the pump removed from their body
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RR00052 | None | None | None |