The Expert System VoiceDiab in Children With Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 1 Diabetes Mellitus With Hyperglycemia, Type 1 Diabetes Mellitus With Hypoglycaemia

Intervention / Treatment
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* Device: VoiceDiab expert system


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VoiceDiab expert system<br>the VoiceDiab system using before every main meal; three times per day. | Device: VoiceDiab expert system<br>* 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.<br>* Other names: patient's decision supporting system;|
| No Intervention: manual calculation<br>manula insulin calculation before every main meal; three times per day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postprandial glucose | postprandial glucose with respect the hyperglycaemia above 180 mg/dl | 96 houres | 

Secondary Outcome Measures

| Outcome Measure | 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), | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bolus calculator, Insulin pump, basal-bolus insulin therapy