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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

NCT03574558 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-12-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Jaeb Center for Health Research

    collaborator OTHER

  • DreaMed

    collaborator INDUSTRY

  • University of Padova

    collaborator OTHER

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-11-25
Completion
2019-11-25

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574558 on ClinicalTrials.gov