The Expert System VoiceDiab in Children With Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: VoiceDiab expert system the VoiceDiab system using before every main meal; three times per day. |
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.
Other Names:
|
| No Intervention: manual calculation manula insulin calculation before every main meal; three times per day |
Outcome Measures
Primary Outcome Measures
- postprandial glucose [96 houres]
postprandial glucose with respect the hyperglycaemia above 180 mg/dl
Secondary Outcome Measures
- AUC [240 mintues after each study's meal]
he Area Under The Curve (AUC) of postprandial glucose level over 240 minutes,
- PPGE- postprandial glucose excursion [96 houres]
Postprandial Glucose Excursions (PPGE), defined as the change in glucose concentration from before the meal to Peak Postprandial Glucose (PPG),
- hypoglycemia [96 houres]
Hypoglycaemic episodes over time of observation measeured by CGM
- LBGI [96 houres]
Low Blood Glucose Index ( LBGI) - as a one of the glucose variability parameters
- Glucose variability parameters [96 houres]
SD total (SDT)- from all days, SD within days (SDw); SD between time points (SDhh:mm); High Blood Glucose Index (HBGI)
Other Outcome Measures
- Quality of life [10 days]
Patients well being when VoiceDiab system is implement
- Patients' acceptances to use VoiceDiab system [10 days]
based on the study's questioner
Eligibility Criteria
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,
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ewa Pankowska | Warsaw | Poland | 04-736 |
Sponsors and Collaborators
- Instytut Diabetologii Sp. z o.o.
- Nalecz Institute of Biocybernetics and Biomedical Engineering, Polish Academy of Sciences
- National Center for Research and Development, Poland
Investigators
- Study Director: Piotr Ladyzynski, PhD, Institute of Biocybernetics and Biomedicin Engineering in Poland
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Błazik M, Pańkowska 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.
- 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.
- 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.
- Pańkowska E, Błazik 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.
- PBS1/B9/13/2012-I