The Expert System VoiceDiab in Children With Diabetes

Type 1 Diabetes Mellitus With Hyperglycemia Clinical Trial

— VoiceDiab  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02403427
• Other study ID #: PBS1/B9/13/2012-I
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2015
• Last updated: May 6, 2015
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2015
• Source: Instytut Diabetologii Sp. z o.o.
• Contact: Ewa Pankowska, PhD
• Phone: +48226164474
• Email: pankowskae[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Poland	Ewa Pankowska	Warsaw

Sponsors (3)

Lead Sponsor	Collaborator
Instytut Diabetologii Sp. z o.o.	Institute of Biocybernetics and Biomedical Engineering Polish Academy of Sciences, National Centre for Research and Development

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life	Patients well being when VoiceDiab system is implement	10 days	No
Other	Patients' acceptances to use VoiceDiab system	based on the study's questioner	10 days	No
Primary	postprandial glucose	postprandial glucose with respect the hyperglycaemia above 180 mg/dl	96 houres	No
Secondary	AUC	he Area Under The Curve (AUC) of postprandial glucose level over 240 minutes,	240 mintues after each study's meal	No
Secondary	PPGE- postprandial glucose excursion	Postprandial Glucose Excursions (PPGE), defined as the change in glucose concentration from before the meal to Peak Postprandial Glucose (PPG),	96 houres	No
Secondary	hypoglycemia	Hypoglycaemic episodes over time of observation measeured by CGM	96 houres	Yes
Secondary	LBGI	Low Blood Glucose Index ( LBGI) - as a one of the glucose variability parameters	96 houres	Yes
Secondary	Glucose variability parameters	SD total (SDT)- from all days, SD within days (SDw); SD between time points (SDhh:mm); High Blood Glucose Index (HBGI)	96 houres	No

External Links

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