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| Name | Class |
|---|---|
| Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences | OTHER |
| National Center for Research and Development, Poland | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VoiceDiab expert system | Experimental | the VoiceDiab system using before every main meal; three times per day. |
|
| manual calculation | No Intervention | manula insulin calculation before every main meal; three times per day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VoiceDiab expert system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| postprandial glucose | postprandial glucose with respect the hyperglycaemia above 180 mg/dl | 96 houres |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | he Area Under The Curve (AUC) of postprandial glucose level over 240 minutes, | 240 mintues after each study's meal |
| PPGE- postprandial glucose excursion | Postprandial Glucose Excursions (PPGE), defined as the change in glucose concentration from before the meal to Peak Postprandial Glucose (PPG), |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Patients well being when VoiceDiab system is implement | 10 days |
| Patients' acceptances to use VoiceDiab system | based on the study's questioner |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ewa Pankowska, PhD | Contact | +48226164474 | pankowskae@gmail.com | |
| Katarzyna Ruszkowska | Contact | +48226164474 | ruszkowska.kasia@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Piotr Ladyzynski, PhD | Institute of Biocybernetics and Biomedicin Engineering in Poland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewa Pankowska | Recruiting | Warsaw | 04-736 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22013887 | Background | 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. | |
| 21447273 | Background | 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. |
| Label | URL |
|---|---|
| pubmed | View source |
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| 96 houres |
| hypoglycemia | Hypoglycaemic episodes over time of observation measeured by CGM | 96 houres |
| LBGI | Low Blood Glucose Index ( LBGI) - as a one of the glucose variability parameters | 96 houres |
| 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 |
| 10 days |
| 24278682 | Background | 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. |
| 17109596 | Background | 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. |
| 22577884 | Result | 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. |
| 20513322 | Result | 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. |
| 19175902 | Result | 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. |