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Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes The DREAMED Trail

NCT02651181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-01-02

No results posted yet for this study

Summary

Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well as reduce glycemic variability.

Several groups around the world investigate efforts in developing closed-loop systems. Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system. The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system . The combined algorithm Hybrid logic closed loop (HLCL) was tested 'In silico' and was proved to be safe and effective. The next step is to test the system in a clinical study in a supervised environment in a camp.

The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes. The MD-Logic system for overnight use "the GlucoSitter" has a CE mark.

The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.

Conditions

Interventions

DEVICE

HLCL- Hybrid Logic Closed Loop System

All subjects wearing the HLCL System and using it with the closed loop algorithm

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Rabin Medical Center

    lead OTHER

Principal Investigators

  • Moshe Phillip, MD, Prof · Rabin Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Israel

Study Locations

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Entities

Diseases
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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 NCT02651181 on ClinicalTrials.gov