Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2015-03-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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VoiceDiab expert system
the VoiceDiab system using before every main meal; three times per day.
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.
manual calculation
manula insulin calculation before every main meal; three times per day
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Treatment with regular insulin,
* Use of any anti-diabetic agent,
3 Years
18 Years
ALL
No
Sponsors
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Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
OTHER
National Center for Research and Development, Poland
OTHER
Instytut Diabetologii Sp. z o.o.
OTHER
Responsible Party
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Ewa Pankowska
associate professor
Principal Investigators
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Piotr Ladyzynski, PhD
Role: STUDY_DIRECTOR
Institute of Biocybernetics and Biomedicin Engineering in Poland
Locations
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Ewa Pankowska
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Pankowska E, Blazik M, Groele L. Does the fat-protein meal increase postprandial glucose level in type 1 diabetes patients on insulin pump: the conclusion of a randomized study. Diabetes Technol Ther. 2012 Jan;14(1):16-22. doi: 10.1089/dia.2011.0083. Epub 2011 Oct 20.
Blazik M, Pankowska E. The education of patients in prandial insulin dosing related to the structure of bolus calculators. Pediatr Endocrinol Diabetes Metab. 2010;16(4):301-5.
Kovatchev BP. Diabetes technology: markers, monitoring, assessment, and control of blood glucose fluctuations in diabetes. Scientifica (Cairo). 2012;2012:283821. doi: 10.6064/2012/283821. Epub 2012 Oct 17.
McCall AL, Cox DJ, Crean J, Gloster M, Kovatchev BP. A novel analytical method for assessing glucose variability: using CGMS in type 1 diabetes mellitus. Diabetes Technol Ther. 2006 Dec;8(6):644-53. doi: 10.1089/dia.2006.8.644.
Blazik M, Pankowska E. The effect of bolus and food calculator Diabetics on glucose variability in children with type 1 diabetes treated with insulin pump: the results of RCT. Pediatr Diabetes. 2012 Nov;13(7):534-9. doi: 10.1111/j.1399-5448.2012.00876.x. Epub 2012 May 14.
Pankowska E, Blazik M. Bolus calculator with nutrition database software, a new concept of prandial insulin programming for pump users. J Diabetes Sci Technol. 2010 May 1;4(3):571-6. doi: 10.1177/193229681000400310.
Pankowska E, Szypowska A, Lipka M, Szpotanska M, Blazik M, Groele L. Application of novel dual wave meal bolus and its impact on glycated hemoglobin A1c level in children with type 1 diabetes. Pediatr Diabetes. 2009 Aug;10(5):298-303. doi: 10.1111/j.1399-5448.2008.00471.x. Epub 2008 Oct 20.
Related Links
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Other Identifiers
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PBS1/B9/13/2012-I
Identifier Type: -
Identifier Source: org_study_id
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