NCT03574558

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 6 Years – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
DEVICE	MD-Logic Switch Advisor	Study algorithm will be used in order to determine the initial pump setting/ MDI dosing while switching from from MDI to pump therapy or vice versa

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-11-25
• Completion: 2019-11-25
• First posted: 2018-07-02
• Last updated: 2019-12-27

Locations

1 site across 1 country: Israel