The Expert System VoiceDiab in Children With Diabetes (VoiceDiab)

May 6, 2015 updated by: Ewa Pankowska, Instytut Diabetologii Sp. z o.o.

The Voice Decision Support Expert System in Basal-bolus Insulin Therapy of Diabetes Patients.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In children with type 1 diabetes glucose deterioration occurred every day and night leading into low satisfaction with treatment. Unstable glycemic profile resulting in high glycemic variability depends on the adjustment of insulin dosing to the current needs of the organism. The calculation of prandial insulin dosing is a complex process which involves such factors as preprandial blood glucose level, the amount of food taken, the glycemic index of carbohydrates, the insulin/carbohydrate exchange ratio, the active insulin level following the previous bolus. Currently, in patients treated with continuous subcutaneous insulin infusion (CSII) insulin pumps are equipped with bolus calculators which help to calculate prandial insulin dosing and thus contribute to improve post-prandial blood glucose levels.

The aim of the study was to determine whether the patient's support expert VoiceDiab system have stabilised diurnal glucose profile in children with type 1 diabetes treated with insulin pumps.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-736
        • Recruiting
        • Ewa Pankowska
        • Contact:
        • Principal Investigator:
          • Ewa Pankowska, PhD
        • Sub-Investigator:
          • Karolina Mazurczak, MD
        • Sub-Investigator:
          • Piotr Foltynski, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed type 1 diabetes at least 12 month prior screening visit
  • Current treatment with basal-bolus regime and insulin pump for at least 12 weeks prior screening visit.
  • HbAc < 11%
  • Ability and willingness to adhere to the protocol including self-management and dealing with mobile device.

Exclusion Criteria:

  • Multiply daily injection modality,
  • Treatment with regular insulin,
  • Use of any anti-diabetic agent,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VoiceDiab expert system
the VoiceDiab system using before every main meal; three times per day.
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.

Other Names:
  • patient's decision supporting system
No Intervention: manual calculation
manula insulin calculation before every main meal; three times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postprandial glucose
Time Frame: 96 houres
postprandial glucose with respect the hyperglycaemia above 180 mg/dl
96 houres

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: 240 mintues after each study's meal
he Area Under The Curve (AUC) of postprandial glucose level over 240 minutes,
240 mintues after each study's meal
PPGE- postprandial glucose excursion
Time Frame: 96 houres
Postprandial Glucose Excursions (PPGE), defined as the change in glucose concentration from before the meal to Peak Postprandial Glucose (PPG),
96 houres
hypoglycemia
Time Frame: 96 houres
Hypoglycaemic episodes over time of observation measeured by CGM
96 houres
LBGI
Time Frame: 96 houres
Low Blood Glucose Index ( LBGI) - as a one of the glucose variability parameters
96 houres
Glucose variability parameters
Time Frame: 96 houres
SD total (SDT)- from all days, SD within days (SDw); SD between time points (SDhh:mm); High Blood Glucose Index (HBGI)
96 houres

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 10 days
Patients well being when VoiceDiab system is implement
10 days
Patients' acceptances to use VoiceDiab system
Time Frame: 10 days
based on the study's questioner
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instytut Diabetologii Sp. z o.o.

Collaborators

National Center for Research and Development, Poland
Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences

Investigators

  • Study Director: Piotr Ladyzynski, PhD, Institute of Biocybernetics and Biomedicin Engineering in Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Estimate)

May 7, 2015

Last Update Submitted That Met QC Criteria

May 6, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBS1/B9/13/2012-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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