Clinical trial investigating the efficacy and safety of insulin delivery with a prototype ultra-low-cost insulin pump in adults with type 1 diabetes

niversity of Canterbury0 sites6 target enrollmentDecember 11, 2023

Overview

No summary available.

Registry

who.int

Start Date

December 11, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Canterbury

•1\. Type 1 diabetes as classified by the American Diabetes Association
•2\. Aged 18 years or older
•3\. Currently using insulin pump therapy for management of diabetes
•4\. Currently receiving basal insulin at a rate compatible with the investigational ultra\-low\-cost insulin pump
•5\. HbA1c \< 97 mmol/mol (11\.0%), based on the mean of all HbA1c results within the 6 months prior to the screening visit, or HbA1c at screening if no results are available
•within the prior 6 months.
•6\. Willing and able to adhere to the study protocol

•1\. A positive pregnancy test at screening is exclusionary
•2\. If female, is currently breastfeeding
•3\. Severe hypoglycaemia or diabetic ketoacidosis in the 6 months prior to study commencement.
•4\. Allergic or intolerant to Humalog® and NovoRapid® insulin
•5\. Alcohol or drug dependence (as reported by participants)
•6\. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study
•7\. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study