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NCT01906970 Clinical Trial

Clinical Experimental Study to Investigate Specific Features of ClampArt®

Diabetes Mellitus Clinical Trial

Official title:
Clinical Experimental Study 2, to Further Investigate the Measurement Accuracy, Glucose Control Quality, Safety, Handling and Functionality of ClampArt® and Its Influence on Pharmacodynamic Parameters in Glucose Clamps

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01906970
Other study ID # ClampArt-ES2
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 19, 2013
Est. completion date July 15, 2024

Study information
Verified date September 2023
Source Profil Institut für Stoffwechselforschung GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A single centre, clinical experimental study. Every subject will undergo clamp experiments, where a clamp device (ClampArt®) measures and controls the blood glucose concentration after administration of marketed insulin products.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date July 15, 2024
Est. primary completion date July 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy, TD1, TD2 Exclusion Criteria: - Participation in a Trial within the last weeks

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ClampArt

Locations
Country Name City State
Germany Profil Institut für Stoffwechselforschung GmbH Neuss NRW

Sponsors (1)
Lead Sponsor Collaborator
Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement accuracy, glucose control quality, safety, handling and functionality of ClampArt® up to 1 year
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