Type 1 DiabetesNCT01709851
Performance Study to Test the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Medical University of Graz at 1 site in Austria.
Trial summary
Over the last years, a number of systems for continuous subcutaneous glucose monitoring have been marketed and are routinely used in patients with diabetes to obtain more detailed information about 24-hour glucose profiles. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Vascular microdialysis using the GMD-system and Vascular and subcutaneous microdialysis using the GMD-system
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2012to Apr 2013
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with type 1 diabetes
Who may be able to join
- Informed consent obtained after being advised of the nature of the study
- Male or female aged 18 - 75 years (both inclusive)
- Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
- Body mass index 20.0 - 29.5 kg/m² (both inclusive)
- HbA1c < 86.0mmol/mol
Who cannot join
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.
- Skin pathology or condition prohibiting needle insertion as judged by the investigator.
- History of bleeding disorder.
- History of heparin-induced thrombocytopenia (HIT)
- Current participation in another clinical study.
- Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator.
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- Lipodystrophy
- Current treatment with systemic (oral or i.v.) corticosteroids or any anticoagulation medication.
- Blood donation or blood loss of more than 500 mL within 12 weeks prior to the study day.
- Known hypersensitivity to Fondaparinux sodium (Arixtra®).
- Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.
- Study day exclusion criteria:
- Non-fasting (i.e. consumption of food or beverages, other than water, later than 22:00 hours the evening before the visit) except if slight intake of rapidly absorbable carbohydrates has been necessary in order to prevent hypoglycaemia.
- Positive result of alcohol breath test.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Dept. of Internal Medicine, Endocrinology and Metabolism
Graz, 8036
About this study
Official title: A Single-center, Open, Pilot Trial to Investigate the Performance of the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes
Over the last years, a number of systems for continuous subcutaneous glucose monitoring have been marketed and are routinely used in patients with diabetes to obtain more detailed information about 24-hour glucose profiles.
In the hospital, numerous factors influencing glycemic control and possibly leading to glucose excursions out of the desired range exist, e.g. interventions for which the patient has to remain fasting or medications such as corticosteroids or vasopressors. A reliable continuous glucose signal could help to observe levels of glycaemia not only at defined time-points but continuously, making it possible for physicians and nursing staff to better adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo- or hyperglycaemia.
Read more
In the hospital setting, vascular access is granted in the majority of patients and could as well be used as an alternative site for continuous glucose monitoring.
The aim of the present study is to assess accuracy of the glucose data obtained by means of an intravascular microdialysis-based CGM system against venous blood glucose reference measurements.
- Conditions
- Type 1 Diabetes
- Being tested
- Vascular microdialysis using the GMD-system, Vascular and subcutaneous microdialysis using the GMD-system
- Keywords
- Type 1 diabetes, Intravascular continuous glucose monitoring, Subcutaneous continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular microdialysis using the GMD-systemDevice
Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system
Vascular and subcutaneous microdialysis using the GMD-systemDevice
Glucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes - vMD and sMD | Patients will undergo vascular (vMD) and subcutaneous microdialysis (sMD) using the GMD-system (GlucoMen(R)Day-system) Receives: Device: Vascular and subcutaneous microdialysis using the GMD-system | |
| Type 1 diabetes - vMD | Patients will undergo vascular microdialysis (vMD) using the GMD-system (GlucoMen(R)Day-system) Receives: Device: Vascular microdialysis using the GMD-system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point Accuracy of the microdialysis signal
MARD (mean absolute relative difference), MARE (mean absolute relative error), %Press analysis
Measured: 72 hours
Secondary outcomes (1)
Rate accuracy of the microdialysis signal
R-EGA (rate error grid analysis) and P-EGA (point error grid analysis)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Menarini Group
- Responsible party
- Sponsor
- Investigators
- Thomas R. Pieber, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709851
- Sponsor's protocol ID
- GMD_05
- Status last verified
- Apr 2013
- First submitted
- 11 Oct 2012
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open, Pilot Trial to Investigate the Performance of the GlucoMen®Day System Using Intravascular and Subcutaneous Microdialysis in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01709851
- Acronym / sponsor ID
- GMD_05
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Intravascular continuous glucose monitoring, Subcutaneous continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Menarini Group
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Oct 2012 (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.
Over the last years, a number of systems for continuous subcutaneous glucose monitoring have been marketed and are routinely used in patients with diabetes to obtain more detailed information about 24-hour glucose profiles.
In the hospital, numerous factors influencing glycemic control and possibly leading to glucose excursions out of the desired range exist, e.g. interventions for which the patient has to remain fasting or medications such as corticosteroids or vasopressors. A reliable continuous glucose signal could help to observe levels of glycaemia not only at defined time-points but continuously, making it possible for physicians and nursing staff to better adjust antihyperglycemic therapy and to react before the patient is exposed to severe hypo- or hyperglycaemia.
In the hospital setting, vascular access is granted in the majority of patients and could as well be used as an alternative site for continuous glucose monitoring.
The aim of the present study is to assess accuracy of the glucose data obtained by means of an intravascular microdialysis-based CGM system against venous blood glucose reference measurements.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes - vMD and sMD | – | Device: Vascular and subcutaneous microdialysis using the GMD-systemPatients will undergo vascular (vMD) and subcutaneous microdialysis (sMD) using the GMD-system (GlucoMen(R)Day-system) |
| Type 1 diabetes - vMD | – | Device: Vascular microdialysis using the GMD-systemPatients will undergo vascular microdialysis (vMD) using the GMD-system (GlucoMen(R)Day-system) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with type 1 diabetes
Key inclusion criteria (5 listed)
- Informed consent obtained after being advised of the nature of the study
- Male or female aged 18 - 75 years (both inclusive)
- Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months
- Body mass index 20.0 - 29.5 kg/m² (both inclusive)
- HbA1c < 86.0mmol/mol
Key exclusion criteria (14 listed)
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods.
- Skin pathology or condition prohibiting needle insertion as judged by the investigator.
- History of bleeding disorder.
- History of heparin-induced thrombocytopenia (HIT)
- Current participation in another clinical study.
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 |
|---|---|---|
| Vascular microdialysis using the GMD-systemGlucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system | Device | Type 1 diabetes - vMD |
| Vascular and subcutaneous microdialysis using the GMD-systemGlucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system | Device | Type 1 Diabetes - vMD and sMD |
Primary outcome
Point Accuracy of the microdialysis signal
Time frame: 72 hours
MARD (mean absolute relative difference), MARE (mean absolute relative error), %Press analysis
1 secondary outcome
Rate accuracy of the microdialysis signal
Time frame: 72 hours
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 16 Apr 2013.
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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.
Thomas R. Pieber, MD principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Medical University of Graz at 1 site in Austria.
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 5 inclusion and 14 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 16 Apr 2013. 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 Austria. 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?
Point Accuracy of the microdialysis signal (time frame: 72 hours). 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 16 Apr 2013.