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

NCT04030091 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-04-01

No results posted yet for this study

Summary

This study is an open label, prospective, randomised comparative, single center study. In the present study, the impact of a 12-week pulsatile insulin infusion therapy (PIT) with Humulin R 100 from

Conditions

  • Diabetes Mellitus, Type 2
  • Diabetes 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.

Sponsors & Collaborators

  • Innovative Diabetes Treatment Studies LLC.

    collaborator UNKNOWN

  • Sciema UG

    lead OTHER

Principal Investigators

  • Andreas Pfuetzner, Prof. Dr. Dr. · Pfützner Science & Health Institute GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-06
Primary Completion
2020-10-19
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04030091 on ClinicalTrials.gov