Feasibility study for Development of an All-In-One Combined Insulin Cannula and Glucose Sensor as Part of a Patch-Pump Closed Loop Insulin Delivery System in Adults with Type 1 Diabetes (Phase 2)

St Vincent's Hospital Melbourne0 个研究点目标入组 3 人开始时间: 2021年9月14日最近更新: 2024年4月8日

适应症

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•Type 1 diabetes, of at least 6 months duration.
•- Age 21-75 Years
•- Insulin pump usage at the time of screening and for at least 3 months prior to screening.
•- HbA1c between 5.8% and 9.0%
•- Willingness and ability to follow all study procedures and to attend all clinic visits.
•- Living with a person knowledgeable regarding the management of hypoglycaemia.
•- No episodes of diabetic ketoacidosis and severe hypoglycaemia within the last 3 months

•- Chronic kidney disease as defined by estimated-GFR < 45 ml/min
•- Inability to read pump or CGM display due to reduced visual acuity
•- Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
•- Cognitive limitations precluding the participant’s ability to operate the insulin pump.
•- Any major active medical condition which in the investigator’s opinion precludes involvement in the
•study. Known active infection such as HIV or hepatitis
•- Schizophrenia or other untreated mental illness
•- Chronic substance abuse
•- Major surgical procedure within 30 days prior to screening
•- Bleeding disorder, or treatment with anticoagulants
•- Allergy to Lispro insulin
•- Allergy to acrylate-based skin adhesives
•- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or
•is not using adequate contraceptive methods.
•- Diabetic ketoacidosis or major hypoglycemia within the last 6 months
•- Insulin resistance as defined by insulin requirement of more than 200 units per day
•- Use of glucose-lowering medications other than insulin
•- Need for uninterrupted treatment with acetaminophen

发起方

St Vincent's Hospital Melbourne