- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02403427
The Expert System VoiceDiab in Children With Diabetes (VoiceDiab)
The Voice Decision Support Expert System in Basal-bolus Insulin Therapy of Diabetes Patients.
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ewa Pankowska, PhD
- Phone Number: +48226164474
- Email: pankowskae@gmail.com
Study Contact Backup
- Name: Katarzyna Ruszkowska
- Phone Number: +48226164474
- Email: ruszkowska.kasia@gmail.com
Study Locations
-
-
-
Warsaw, Poland, 04-736
- Recruiting
- Ewa Pankowska
-
Contact:
- Katarzyna Ruszkowska
- Phone Number: +48226164474
- Email: ruszkowska.kasia@gmail.com
-
Principal Investigator:
- Ewa Pankowska, PhD
-
Sub-Investigator:
- Karolina Mazurczak, MD
-
Sub-Investigator:
- Piotr Foltynski, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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:
|
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
Sponsor
Collaborators
Investigators
- Study Director: Piotr Ladyzynski, PhD, Institute of Biocybernetics and Biomedicin Engineering in Poland
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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