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Feasibility and Safety Study of the Automated Insulin Delivery Closed Loop System Pancreas4ALL

NCT04835350 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-04-08

No results posted yet for this study

Summary

Pilot prospective controlled monocentric open-label, randomized study evaluating the feasibility and safety of the Pancreas4All automated "closed loop" glycemic control system.

Conditions

Interventions

DEVICE

Pancreas4ALL - meal announcement or full closed loop

Patient using AID Pancreas4ALL in mode meal announcment or full closed loop.

Sponsors & Collaborators

  • CLOSED LOOP Systems s.r.o.

    collaborator UNKNOWN

  • Lenka Petruzelkova

    lead OTHER

Principal Investigators

  • Lenka Petruzelkova, MD, PhD · Department of Paediatrics, Motol University Hospital, Charles University

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-19
Primary Completion
2021-04-30
Completion
2021-05-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04835350 on ClinicalTrials.gov