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The Expert System VoiceDiab in Children With Diabetes

NCT02403427 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2015-05-07

No results posted yet for this study

Summary

The purpose of this study to conduct the preliminary investigation on the efficacy and safety in terms of postprandial glucose value and the rates of hypoglycaemia when expert VoiceDiab system supports patient's decision on prandial insulin programming in insulin pump therapy.

Conditions

  • Type 1 Diabetes Mellitus With Hyperglycemia
  • Type 1 Diabetes Mellitus With Hypoglycaemia

Interventions

DEVICE

VoiceDiab expert system

Decision support system VoiceDiab this is computer-based system constructed for mobile phone devices working on the server. Patients in experimental arm get the mobile phone application for 4 days. Glucose control will be done by two methods SMPG and CGM. Before every study's meal insulin dose with type of bolus will be indicate by VoiceDiab.

Sponsors & Collaborators

  • Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

    collaborator OTHER

  • National Center for Research and Development, Poland

    collaborator OTHER

  • Instytut Diabetologii Sp. z o.o.

    lead OTHER

Principal Investigators

  • Piotr Ladyzynski, PhD · Institute of Biocybernetics and Biomedicin Engineering in Poland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-09-30
Completion
2015-12-31

Countries

  • Poland

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 NCT02403427 on ClinicalTrials.gov