Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT03574558
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2018-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
Personalized Automated Determination of Insulin Pump Setting for Subjects With Type 1 Diabetes Switching From MDI to Pump Therapy and Vice Versa- Safety and Efficacy Feasibility Study
Status:
COMPLETED
Status Verified Date:
2019-01
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:
The "MD-Logic Switch Advisor" is a software product that is designed to assist in insulin dosage decision making and has two components:
A. MD-Logic Switch Advisor for initiation of pump therapy - this product is designed to assist physicians in decision making when initiating insulin pump therapy.
B. MD-Logic Switch Advisor for patients who use insulin pump therapy and need to switch to MDI (Multiple Daily Injections).
This feasibility study will be divided to two parts:
part A - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from MDI to pump therapy part B - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from pump therapy to MDI The main objective is to evaluate the safety and efficacy of using the MD-Logic Switch Advisor to determine insulin dosing for subjects with type 1 diabetes using pump therapy who wish to switch to from pump to MDI therapy and vice versa.
A. MD-Logic Switch Advisor for initiation of pump therapy - this product is designed to assist physicians in decision making when initiating insulin pump therapy.
B. MD-Logic Switch Advisor for patients who use insulin pump therapy and need to switch to MDI (Multiple Daily Injections).
This feasibility study will be divided to two parts:
part A - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from MDI to pump therapy part B - will include up to 20 patients to evaluate in a feasibility study the switch Advisor from pump therapy to MDI The main objective is to evaluate the safety and efficacy of using the MD-Logic Switch Advisor to determine insulin dosing for subjects with type 1 diabetes using pump therapy who wish to switch to from pump to MDI therapy and vice versa.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: