NCT01906970

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
Last Updated

September 24, 2024

Status Verified

September 1, 2024

Enrollment Period

11 years

First QC Date

July 11, 2013

Last Update Submit

September 23, 2024

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Measurement accuracy, glucose control quality, safety, handling and functionality of ClampArt®

    up to 1 year

Study Arms (1)

ClampArt

EXPERIMENTAL

ClampArt

Device: ClampArt

Interventions

ClampArtDEVICE
ClampArt

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, TD1, TD2

You may not qualify if:

  • Participation in a Trial within the last weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tim Heise, MD

    Profil Institut für Stoffwechselforschung GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 24, 2013

Study Start

June 19, 2013

Primary Completion

June 26, 2024

Study Completion

June 26, 2024

Last Updated

September 24, 2024

Record last verified: 2024-09

Locations

DE(1)