Observational Study on the Use of the Insulin Pump Tandem X:2 With Control IQ Algorithm - Update
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time in glucose range 70 - 180mg/dl (%)
研究概览
简要总结
The aim of this observational clinical trial is to obtain data on the safety, efficacy and satisfaction of the Tandem T:Slim X:2 Pump System in patients with type 1 diabetes.
详细描述
This is a non-randomized, non-blinded, prospective, observational single-center study, enrolling 2x 25 subjects in two cohorts (25 subjects in SWITCH group and 25 subjects in START group) with diabetes mellitus for up to 12 weeks. The study will evaluate the effectiveness of the insulin therapy with the pump system Tandem t:slim X:2 with the special algorithm "Control IQ" in comparison to each other. The test system including the Control IQ software will provide an Hybrid-Closed loop - Modus, which can predict the future tissue glucose value and continuously adjust the insulin infusion according to need. The aim is to keep the glucose value permanently within the target range and to avoid hypoglycaemia or hyperglycaemia.
Group START starts from any other diabetes therapy (MDI, PLGM (=Predictive Low Glucose Suspend), SaP (=Sensor augmented Pump)) directly to T:Slim pump with control IQ; group SWITCH switches from former use of T:slim with Basal IQ.
The study includes two visits only (start and end). At the beginning all patients have to complete questionnaires, and the data of the glucose sensor are read out and the metric data are determined and laid down.
Depending on the previous form of therapy, the patients are assigned to the corresponding cohort. All participants and parents, regardless of which cohort, receive a technical briefing from the study team as well as training on how to use the new system or algorithm. Subsequently, the system will be applied in everyday life in the coming weeks. After 12 weeks (end of study), the insulin pump is read out and the questionnaire on satisfaction with the device is filled out again.
After the end of the study, the patients participate in standard medical care as before.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •type 1 diabetes
- •Age >6 years
- •at least 10 IE daily total Insulin dose and 25 kg Body weight
- •Group SWITCH: already user of t:slim X2 with Basal IQ
- •Group START: Granting of the insulin pump t:slim X2 and DexCom G6 by the health insurance
排除标准
- •1.Refusal of participation by the participant or a parent
结局指标
主要结局
Time in glucose range 70 - 180mg/dl (%)
时间窗: 12 weeks
Both groups are evaluated together. Comparison of the time (%) in the glucose range 70 - 180mg/dl of the last two weeks of the study with the time in the target range two weeks before the start of the study.
次要结局
- mean daily insulin amount(12 weeks)
- mean daily insulin amount before study start(two weeks)
- user satisfaction assessed by disabkids questionnaire for children and for parents(12 weeks)
- mean glucose Level before study start [mg/dl](two weeks)
- mean glucose level [mg/dl](two weeks)