Research Study to Look at Fast-acting Insulin Aspart With the Insulin Pump System 'iLet™' in Adults With Type 1 Diabetes

Summary

The iLet™ is a new insulin pump that is programmed to work with a Continuous Glucose Monitoring (CGM) device. This is to give participants insulin automatically. The CGM device is already available for sale. The iLet™ is not yet approved for use. Fast-acting insulin aspart is a type of insulin that doctors can already prescribe for use with insulin pens, but not for use in an insulin pump. This study is to test how safe fast acting insulin aspart is when used with different insulin delivery settings in the iLet™ in people with type 1 diabetes. Participants will get fast-acting insulin aspart as participants' insulin and use the iLet™ as participants' insulin pump with a CGM device. Participants' iLet™ will be set to 2 different insulin delivery settings for 7 days on each setting. The setting participants get first is decided by chance. The study will last for about 5 to 9 weeks. Participants will have 4 visits and 1 phone contact with the study or staff.

Timeline

Start

2019-02-25

Primary completion

2019-05-31

Completion

2019-06-10

Publications

• Russell SJ, Balliro C, Ekelund M, El-Khatib F, Graungaard T, Greaux E, Hillard M, Jafri RZ, Rathor N, Selagamsetty R, Sherwood J, Damiano ER. Improvements in Glycemic Control Achieved by Altering the tmax Setting in the iLet(R) Bionic Pancreas When Using Fast-Acting Insulin Aspart: A Randomized Trial. Diabetes Ther. 2021 Jul;12(7):2019-2033. doi: 10.1007/s13300-021-01087-x. Epub 2021 Jun 19.

Drugs

Indications