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 sites65 target enrollmentSeptember 8, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 8, 2021

End Date

February 20, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

St Vincent's Hospital Melbourne

•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