The Voice Decision Support Expert System in Basal-bolus Insulin Therapy of Diabetes Patients.
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- postprandial glucose
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Multiply daily injection modality,
- •Treatment with regular insulin,
- •Use of any anti-diabetic agent,
研究组 & 干预措施
VoiceDiab expert system
the VoiceDiab system using before every main meal; three times per day.
干预措施: VoiceDiab expert system (Device)
manual calculation
manula insulin calculation before every main meal; three times per day
结局指标
主要结局
postprandial glucose
时间窗: 96 houres
postprandial glucose with respect the hyperglycaemia above 180 mg/dl
次要结局
- LBGI(96 houres)
- Glucose variability parameters(96 houres)
- hypoglycemia(96 houres)
- AUC(240 mintues after each study's meal)
- PPGE- postprandial glucose excursion(96 houres)
研究者
Ewa Pankowska
associate professor
Instytut Diabetologii Sp. z o.o.