Diabetes MellitusNCT01906970
Clinical Experimental Study to Investigate Specific Features of ClampArt®
A study testing ClampArt in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- ClampArt
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jun 2013to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, TD1, TD2
Who cannot join
- Participation in a Trial within the last weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site
Profil Institut für Stoffwechselforschung GmbH
Neuss, North Rhine-Westphalia, 41460
About this study
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
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.
- Conditions
- Diabetes Mellitus
- Being tested
- ClampArt
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClampArtDevice
| Study group | Role | What they receive |
|---|---|---|
| ClampArt | Experimental | ClampArt Receives: Device: ClampArt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement accuracy, glucose control quality, safety, handling and functionality of ClampArt®
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study start19 Jun 2013
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Heise, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906970
- Sponsor's protocol ID
- ClampArt-ES2
- Status last verified
- Sep 2024
- First submitted
- 11 Jul 2013
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01906970
- Acronym / sponsor ID
- ClampArt-ES2
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2013 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ClampArt | Experimental | Device: ClampArtClampArt |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, TD1, TD2
Key exclusion criteria (1 listed)
- Participation in a Trial within the last weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClampArt | Device | ClampArt |
Primary outcome
Measurement accuracy, glucose control quality, safety, handling and functionality of ClampArt®
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Heise, MD principal investigator
Profil Institut für Stoffwechselforschung GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ClampArt in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement accuracy, glucose control quality, safety, handling and functionality of ClampArt® (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.