The Expert System VoiceDiab in Children With Diabetes
VoiceDiab
The Voice Decision Support Expert System in Basal-bolus Insulin Therapy of Diabetes Patients.
1 other identifier
interventional
42
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMay 7, 2015
May 1, 2015
6 months
March 26, 2015
May 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postprandial glucose
postprandial glucose with respect the hyperglycaemia above 180 mg/dl
96 houres
Secondary Outcomes (5)
AUC
240 mintues after each study's meal
PPGE- postprandial glucose excursion
96 houres
hypoglycemia
96 houres
LBGI
96 houres
Glucose variability parameters
96 houres
Other Outcomes (2)
Quality of life
10 days
Patients' acceptances to use VoiceDiab system
10 days
Study Arms (2)
VoiceDiab expert system
EXPERIMENTALthe VoiceDiab system using before every main meal; three times per day.
manual calculation
NO INTERVENTIONmanula insulin calculation before every main meal; three times per day
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Multiply daily injection modality,
- Treatment with regular insulin,
- Use of any anti-diabetic agent,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ewa Pankowska
Warsaw, 04-736, Poland
Related Publications (7)
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.
PMID: 22013887BACKGROUNDBlazik 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.
PMID: 21447273BACKGROUNDKovatchev 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.
PMID: 24278682BACKGROUNDMcCall 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.
PMID: 17109596BACKGROUNDBlazik 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.
PMID: 22577884RESULTPankowska 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.
PMID: 20513322RESULTPankowska 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.
PMID: 19175902RESULT
Related Links
Study Officials
- STUDY DIRECTOR
Piotr Ladyzynski, PhD
Institute of Biocybernetics and Biomedicin Engineering in Poland
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
March 26, 2015
First Posted
March 31, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
May 7, 2015
Record last verified: 2015-05