The Expert System VoiceDiab in Children With Diabetes

Instytut Diabetologii Sp. z o.o.

Status: Unknown

Conditions: Type 1 Diabetes Mellitus With Hyperglycemia; Type 1 Diabetes Mellitus With Hypoglycaemia

Treatments: Device: VoiceDiab expert system

Study type: Interventional

Funder types: Other

Identifiers

NCT02403427

PBS1/B9/13/2012-I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

VoiceDiab expert system

Experimental group

Description:

the VoiceDiab system using before every main meal; three times per day.

Treatment:

Device: VoiceDiab expert system

manual calculation

No Intervention group

Description:

manula insulin calculation before every main meal; three times per day