NCT06979635尚未招募不适用
Assessing the Safety, Performance, and User Experience of the Tandem Mobi Automated Insulin Delivery System Among Young Competitive Athletes in Real-world Settings.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Sensor glucose percentage of time in range (70-180 mg/dl)
研究概览
简要总结
A single arm, interventional study with 12 weeks study phase preceded by a 2-week run in phase, aiming to evaluate the effectiveness and applicability of the Tandem Mobi automated insulin delivery system (Tandem Mobi Pump System) for competitive youth athletes with type 1 diabetes in real-world conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes (T1D) for at least 6 months
- •11≤Age≤18 years
- •HbA1c <10.0%
- •Current treatment with automated insulin delivery system (AID) or insulin pump for at least 1 month
- •Willing to switch to Tandem Mobi Pump System and Dexcom CGM for the study duration
- •Competitive-level athletes
排除标准
- •Concomitant disease that influences metabolic control or HbA1c interpretation
- •Individual has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- •Use of antidiabetic agents other than insulin
- •Two or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by another person) within the previous 6 months
- •One or more episodes of ketoacidosis requiring hospitalization within 6 months prior to screening
- •Individual has a positive pregnancy screening test
结局指标
主要结局
Sensor glucose percentage of time in range (70-180 mg/dl)
时间窗: At the end of the 12 weeks intervention period
次要结局
- Percentage of sensor glucose readings <54 mg/dl(At the end of the 12 weeks intervention period)
- Percentage of sensor glucose readings >180 mg/dl(At the end of the 12 weeks intervention period)
- Percentage of sensor glucose readings >250 mg/dl(At the end of the 12 weeks intervention period)
- HbA1c(At the end of the 12 weeks intervention period)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
2 期
EUS-RFA PANCARDINAL-1 TrialPancreatic Ductal Adenocarcinoma (PDAC)NCT04990609The University of Texas Health Science Center, Houston60
已完成
1 期
Testing safety and efficacy of a live bacterial therapy for the treatment of Helicobacter pylori infectioInfection - Other infectious diseasesOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonHelicobacter pylori infectionACTRN12620000923965Servatus Ltd28
已完成
2 期
Safety, Tolerability, and Efficacy of 12-weeks of Sovaprevir, ACH-3102, and Ribavirin in Treatment-naive GT-1 HCV ParticipantsHepatitis C, ChronicNCT01849562Alexion Pharmaceuticals, Inc.30
已完成
2 期
Single-arm phase II to evaluate the safety and efficacy of Campath in combination with high-dose methylprednisolone in CLL patients with deletion of the p53 tumour suppressor gene.Topic: National Cancer Research NetworkSubtopic: Haematological OncologyDisease: Leukaemia (chronic)LeukaemiaCancerISRCTN38006233niversity of Liverpool (UK)40
尚未招募
2 期
eoadjuvant Short course radiotherapy in esophageal carcinomaCTRI/2020/12/029851AIIMS Rishikesh