Pilot study to determine Time in HYpoglycaemia when using pre-MixEd (biphasic) insulin

Abbott Diabetes Care Ltd0 sites43 target enrollmentMay 22, 2019

Overview

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34464470/ (added 01/07/2022)

Registry

who.int

Start Date

May 22, 2019

End Date

August 7, 2019

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Abbott Diabetes Care Ltd

•1\. Aged 18 years or over.
•2\. Type 2 diabetes treated with pre\-mixed (biphasic) insulin for at least 6 months prior to study enrolment.
•3\. Most recent HbA1c less than 7\.5% (58 mmol/mol), recorded in medical notes in last 12 months.

•1\. Currently prescribed animal insulin.
•2\. Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition.
•3\. Has a pacemaker or any other neurostimulators.
•4\. Currently receiving dialysis treatment or planning to receive dialysis during the study.
•5\. Women who are pregnant, plan to become pregnant or become pregnant during the study.
•6\. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
•7\. Known (or suspected) allergy to medical grade adhesives.
•8\. In the investigator’s opinion, unsuitable to participate due to any other cause/reason.