NCT01267175已完成4 期
United Kingdom User Evaluation, MiniMed Paradigm® X54 System
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 12
- 主要终点
- Usability of the X54 Insulin Pump Meets Expectations
研究概览
简要总结
The user evaluation is to assess user acceptance and the quality of training materials for the MiniMed Paradigm® X54 System (X54 System) in preparation for commercial distribution of the new system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are current 512/712, 515/715 or 522/722 MiniMed Paradigm Insulin Pump users, with or without CGM experience, and have at least three months experience with any one of these devices;
- •Have signed an Informed Consent and are willing to comply with the user evaluation procedures;
- •Have an HbA1c value less than 9.0% recorded at the time of their last test (if no HbA1c value is available within three months of enrollment, an HbA1c should be performed prior to entry to verify inclusion criteria);
- •Are willing to use the Bolus Wizard feature;
- •Agree to complete a diary for the duration of the study;
- •Agree to complete a questionnaire at the conclusion of the study;
- •Have been diagnosed with Type 1 Diabetes Mellitus by appropriate fasting or non fasting lab blood glucose values, c-peptide, insulin antibodies, prior documented DKA or good clinical picture at least six months prior to study start;
- •Are 18 - 65 years of age;
- •Have access to the internet and agree to upload the device per protocol
排除标准
- •Is pregnant or planning to become pregnant during the course of the user evaluation. Pregnancy screening will be completed during the routine office visit prior to evaluation for the study. If a woman becomes pregnant during participation, she will be withdrawn;
- •Suffers from a chronic debilitating condition;
- •Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study;
- •Has impaired vision or hearing problems that could compromise the handling of the device;
- •Has a history of tape allergies or skin conditions that could interfere with continued use of the system;
- •Has the potential for lack of compliance or any other issue, in the opinion of the Investigator, that may preclude the subject from satisfactory participation in the study;
- •Has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled;
- •Is currently participating in an investigational study (drug or device).
结局指标
主要结局
Usability of the X54 Insulin Pump Meets Expectations
时间窗: 5 weeks
Questionnaire completed at the end of the study measuring usability of the X54 insulin pump. Results scored on a Likert scale of 1 - 7, 1 being the least likely to use and 7 being the most likely to use.
次要结局
- Usability of the Training Material Meets Expectations(5 weeks)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Validation of Patient Reported Outcome Measures for Use in VulvodyniaVulvodyniaNCT03770169Ipsen20
Unknown
不适用
A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)Diabetes MellitusNCT03851549LifeScan Scotland Ltd360
已完成
不适用
Evaluation of Labeling Comprehension and Performance of a New Blood Glucose Meter SystemDiabetesNCT00804596Ascensia Diabetes Care74
已完成
不适用
PREventive Care Infrastructure Based On Ubiquitous Sensing (PRECIOUS). VHIR Pilot.ObesityNCT02818790Hospital Universitari Vall d'Hebron Research Institute30
已完成
不适用
An evaluation of user acceptance and performance of a mobile real-time continuous glucose monitoring system.Type 1 Diabetes.Metabolic and Endocrine - DiabetesACTRN12615000785505St Vincents Hospital Melbourne10