24
Participants
Start Date
September 6, 2019
Primary Completion Date
October 19, 2020
Study Completion Date
December 31, 2020
3 hours humulin R 100 IU/mL PIT
PIT procedure: a venous catheter will be placed into one superficial vein at one arm, which will be connected to the insulin infusion pump and a glucose infusion pump via a three-way connector. Endothelial function will be measured by means of the Vendys 2 device. The blood glucose will be tested by means of a POCT meter and the CGM, and the PIT procedure will be started (10 pulses of 3 U of regular human insulin per hour). Blood glucose will be tested every 5 to 10 min and glucose infusion will be started once a drop in blood glucose is detected. Adjustment of glucose administration will be performed until a stable glucose value between 80 mg/dL to 160 mg/dL is reached. In parallel, endothelial function will be measured every 30 min. At the end of the PIT procedure, the venous catheter will be removed and the patient will be discharged until the next visit.
2 hours humulin R 100 IU/mL PIT
"As described for the Intervention 3 hours of pulsatile insulin infusion (PIT) with humulin R 100 IU/mL, the treatment duration is just one hour less."
NYC Research, Inc., New York
Pfützner Science & Health Institute GmbH, Mainz
Innovative Diabetes Treatment Studies LLC.
UNKNOWN
Sciema UG
OTHER