Type 1 Diabetes Mellitus With Hyperglycemia Clinical Trial
Official title:
The Voice Decision Support Expert System in Basal-bolus Insulin Therapy of Diabetes Patients.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06097689 -
A Pilot Study to Assess the Feasibility of a Novel Non-invasive Technology to Measure Changing Blood Glucose Levels in Adults With Type-1 Diabetes Mellitus
|
N/A |