NL-OMON51696撤回不适用
InPenTM User Experience - InPenTM User Experience
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Inclusion Criteria:
- •1. Subject is aged 18-75 years at time of screening
- •2. Subject is on MDI therapy (defined as >= 3 insulin injections per day and on
- •a basal/bolus regimen) >=1 year prior to screening
- •3. Subject has a clinical diagnosis of type 1 diabetes for 1 year prior to
- •4. Subject has a Glycosylated hemoglobin (HbA1c) less than 12% as assessed by
- •local lab or capillary blood testing <15 days prior to screening or at time of
- •screening visit
- •5. Subject is on MDI therapy with
- •b. Real-Time Continuous Glucose Monitoring (rtCGM), or
- •c. Intermittent Scanning CGM (iscCGM)
- •6. Subject is willing to upload data from a BG meter, must have internet access
- •and a compatible computer system that meets the requirements for uploading data
- •7. Subject is willing and able to sign and date informed consent, comply with
- •all study procedures, and wear all study devices, as required during the study.
- •8. Subject is willing to take or switch to one of the InPen-compatible insulin
- •types, as per IFU
排除标准
- •1. Women of child-bearing potential who have a positive pregnancy test at
- •screening or plan to become pregnant during the course of the study.
- •2. Women who are breastfeeding.
- •3. Subject has any unresolved adverse skin conditions in the area of sensor
- •placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus
- •infection).
- •4. Subject is actively participating in an investigational study (drug or
- •device) wherein he/she has received treatment from an investigational study
- •drug or device in the last 2 weeks before enrollment into this study, as per
- •investigator judgment.
- •5. Subject is currently abusing illicit drugs, marijuana, alcohol or
- •prescription drugs (other than nicotine), per investigator judgment.
- •6. Subject has any other disease or condition that may preclude the patient
- •from participating in the study, per investigator judgment.
- •7. Subject is legally incompetent, illiterate or vulnerable person.
- •8. Research staff involved with executing the study.
研究者
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