Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01501032
Status:
WITHDRAWN
Last Update Posted:
2015-03-19
First Post:
2011-12-14
Brief Title:
Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients
Status:
WITHDRAWN
Status Verified Date:
2015-03
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:
MD-Logic- Cont
Brief Summary:
The purpose of this feasibility study is to evaluate the MDLAP MD-Logic Artificial Pancreas systemautomated insulin management system using continuous glucose monitoring CGM and subcutaneous insulin pump infusion in individuals with type 1 diabetes The study will include 3 inpatient admissions 12-24 hr which will include overnight sleep over-bolus meal under-bolus meal and exercise
Detailed Description:
The purpose of this feasibility study is to evaluate the MDLAP MD-Logic artificial pancreas systemautomated insulin management system using continuous glucose monitoring CGM and subcutaneous insulin pump infusion in individuals with type 1 diabetes The study will include 3 inpatient admissions 12-24 hr which will include overnight sleep over-bolus meal under-bolus meal and exercise During the the visits meal boluses will be semi-automated with manual meal announcement by the physiciannurse automated bolus recommendation by the system and automated delivery of the bolus following confirmation of the recommendation Between-meal insulin dosing will be fully automated Bolus confirmation by the physiciannurse will be requested by the closed loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus
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