A Pilot Study Comparing Treatment Satisfaction with the Omnipod Insulin Pump Compared with Usual Care in Adults with Type 1 Diabetes Living in Australia

St Vincent's Hospital Melbourne0 个研究点目标入组 65 人开始时间: 2021年9月8日最近更新: 2023年10月23日

适应症

试验速览

暂无简介。

•1. Clinical diagnosis of type 1 diabetes (as defined by the American Diabetes Association) of at least six months duration managed with multiple daily injections (MDI) or insulin pump therapy (IPT)
•2. Age 18-70 years old
•3. Fluent in English (reading and writing)
•4. Willing to perform at least four self-monitoring of blood glucose (SMBG) readings each day
•5. Willing to learn how to carbohydrate count and to apply this knowledge
•6. HbA1c <10.0%
•7. Willing to use an Omnipod DASH insulin pump
•8. Has a computer with internet access
•9. Has access to a smart device with data plan.

•1. Using real time-CGM defined as use >25% of the time during the past 3 months (Abbott Libre allowed)
•2. An episode of severe hypoglycaemia or DKA within the preceding three months
•3. A physical or intellectual disability precluding the use of insulin pump therapy
•4. Severe renal impairment (eGFR <15 ml per minute per 1.73m2)
•5. Haemoglobinopathy or haemolytic anemia due to its interference with HbA1c assays
•6. Major life-threatening illness impacting immediate life expectancy
•7. Use of any non-insulin glucose-lowering agent within the past 3 months
•8. Oral or injected corticosteroid use within the past 3 months
•9. Pregnancy, or pregnancy planned within study period
•10. Uncontrolled thyroid disease, celiac disease or hypertension
•11. A requirement for more than 200 I.U. of insulin every two days.

发起方

St Vincent's Hospital Melbourne