Clinical trial NCT02403427: The Expert System VoiceDiab in Children With Diabetes
Official title: The Voice Decision Support Expert System in Basal-bolus Insulin Therapy of Diabetes Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes Mellitus With Hyperglycemia
Type 1 Diabetes Mellitus With Hypoglycaemia
Keywords: Bolus calculator
Insulin pump
basal-bolus insulin therapy
Lead sponsor: Instytut Diabetologii Sp. z o.o.
Sponsor class: OTHER
Collaborators: name: Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
name: National Center for Research and Development, Poland
First posted: 2015-03-31
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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,

Primary outcomes:
measure: postprandial glucose
timeFrame: 96 houres
Secondary outcomes:
measure: AUC
timeFrame: 240 mintues after each study's meal
measure: PPGE- postprandial glucose excursion
timeFrame: 96 houres
measure: hypoglycemia
timeFrame: 96 houres
measure: LBGI
timeFrame: 96 houres
measure: Glucose variability parameters
timeFrame: 96 houres
Other outcomes:
measure: Quality of life
timeFrame: 10 days
measure: Patients' acceptances to use VoiceDiab system
timeFrame: 10 days
Locations:
city: Warsaw
country: Poland
facility: Ewa Pankowska
Study officials:
affiliation: Institute of Biocybernetics and Biomedicin Engineering in Poland
name: Piotr Ladyzynski, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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. doi: 10.1089/dia.2006.8.644.
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. Epub 2012 May 14.
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. doi: 10.1177/193229681000400310.
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.1399-5448.2008.00471.x. Epub 2008 Oct 20.