Study of MiniMed* 640G Insulin Pump with SmartGuard* in prevention of Low Glucose Events in adults with Type 1 diabetes (CEP311) - SMILE

Medtronic B.V.0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•1. Age 24-75 years old at time of screening.
•2. Diagnosed with Type 1 diabetes *10 years prior to screening.
•3. On CSII therapy for * 6 months prior to screening.
•4. Not on Real Time Continuous Glucose Monitoring for * 3 months prior to screening.
•5. HbA1c value *5.8% and *10.0% as assessed by local lab * 15 days prior to screening or performed at screening.
•6. A documented Severe Hypoglycemia event * 12 months prior to screening, OR Clarke score *4 assessed at time of screening, OR Gold score *4 assessed at time of screening.
•7. Subject is willing to sign and date informed consent, comply with all study procedures and wear all study devices as required during the study.

•1. Untreated Addison*s disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
•2. Subject is using Pramlintide (Symlin) SGLT2 inhibitor, GLP agonist at time of screening.
•3. Renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test * 3 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft or MDRD equations.
•4. Hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
•5. Current pregnancy or intention to conceive.
•6. Any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection).
•7. Alcohol or drug abuse, other than nicotine, per investigator judgment.
•8. Any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
•9. Legally incompetent, illiterate or vulnerable person.

发起方