Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus

PHASE4CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 6, 2019

Primary Completion Date

October 19, 2020

Study Completion Date

December 31, 2020

Conditions
Diabetes Mellitus, Type 2Diabetes Mellitus, Type 1
Interventions
DRUG

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.

DRUG

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."

Trial Locations (2)

10455

NYC Research, Inc., New York

55128

Pfützner Science & Health Institute GmbH, Mainz

All Listed Sponsors
collaborator

Innovative Diabetes Treatment Studies LLC.

UNKNOWN

lead

Sciema UG

OTHER

NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter