Clinical Experimental Study to Investigate Specific Features of ClampArt®

September 23, 2024 updated by: Profil Institut für Stoffwechselforschung GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Neuss, NRW, Germany, 41460
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy, TD1, TD2

Exclusion Criteria:

  • Participation in a Trial within the last weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ClampArt
Device: ClampArt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement accuracy, glucose control quality, safety, handling and functionality of ClampArt®
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Profil Institut für Stoffwechselforschung GmbH

Investigators

  • Principal Investigator: Tim Heise, MD, Profil Institut für Stoffwechselforschung GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2013

Primary Completion (Actual)

June 26, 2024

Study Completion (Actual)

June 26, 2024

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimated)

July 24, 2013

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ClampArt-ES2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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