Type 1 DiabetesPhase 1NCT01407315
Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor
A Phase 1 study testing GlucoMenDay in people with Type 1 Diabetes, run by Medical University of Graz at 1 site in Austria.
Trial summary
Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped with the GlucoMen®Day system, over up to 100 hours observation after implantation of the microdialysis probe. Different meal/hypo procedures will be performed at the study centre. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- GlucoMenDay
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2010to Dec 2010
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Established diagnosis of type-1-diabetes
- Ability to provide informed consent
- Age 18-75 years
Who cannot join
- Subjects under anti-coagulant treatments
- Alcoholism
- Body mass index (BMI) > 32 kg/m2
- Inability to adhere to the protocol or to attend the required follow- up visits and tests
- Diseases or conditions of the abdominal wall which, in the opinion of Clinician might contraindicate the insertion of the hypodermic needle into the subcutaneous tissue
- Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
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- Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study
- Subjects currently participating in a clinical study
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped with the GlucoMen®Day system, over up to 100 hours observation after implantation of the microdialysis probe. Different meal/hypo procedures will be performed at the study centre.
Read the detailed description
This is a monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, who will be equipped with the GlucoMen®Day system.
Each subject will be investigated for up to 100 hours after implantation of the microdialysis probe.
In order to verify the clinical effectiveness of the GlucoMenDay the subjects will be asked to perform a total of six self testing measurements per day using the GlucoCard G-Meter according to the following scheme:
- before breakfast
- before lunch
- 60-120 minutes after lunch
- before dinner
- 60-120 minutes after dinner
- at 3 AM
Subjects will be asked to come to the research facility every day to obtain a venous blood sample and to check system functioning.
Subjects will be randomized either to Procedure A - Multiple sampling or Procedure B - Meal/Insulin test.
Procedure A - Multiple sampling:
This procedure can be performed at days 2-4 of the study period. Subjects will receive a standardized lunch (100 g of CHO), administration of insulin will be performed by the subject based on insulin to carbohydrate ratio. An intravenous catheter will be inserted in one forearm and venous sampling will start 1 hour after lunch ingestion. Arterialized-venous blood sampling will be performed every 15 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly capillary measurements using the GlucoCard G Meter will be performed.
Procedure B - Meal/Insulin test:
This procedure will be performed on days 2 and four of the experiment. Subjects randomized to procedure B will be asked to undergo this investigation twice.
Subjects will receive a standard breakfast (75g CHO), the usual morning insulin dose will be post-poned. An increased dose of rapid-acting insulin analogue aiming to produce minor hypoglycaemia based on insulin to carbohydrate ratio will be injected subcutaneously. Arterialized-venous sampling will be performed every 10 minutes for a period of two hours.
Samples will be analyzed for glucose using the Super GL; concomitantly, capillary measurements using the GlucoCard G Meter will be performed.
On day 5 subjects will return to the clinical trial unit for collection of a final blood sample and removal of the device.
Subjects will be asked to come to the research facility at 48 and 72 hours after removal of the device for an evaluation of local site reactions.
- Conditions
- Type 1 Diabetes
- Being tested
- GlucoMenDay
- Keywords
- Continuous subcutaneous glucose monitoring, Type 1 Diabetes
- 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.
GlucoMenDayDevice
Also called Continuous Glucose Monitoring
Subjects will receive a standardized lunch (100 g of CHO), administration of insulin will be performed by the subject based on insulin to carbohydrate ratio.
An intravenous catheter will be inserted in one forearm and venous sampling will start 1 hour after lunch ingestion. Arterialized-venous blood sampling will be performed every 15 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly capillary measurements using the GlucoCard G Meter will be performed.
This procedure can be performed on days 3-4 of monitoring; each subject randomized to Procedure A undergoes this procedure once.
GlucoMenDayDevice
Also called Continuous Glucose Monitoring
Subjects will receive a standard breakfast (75g CHO), the usual morning insulin dose will be post-poned. An increased dose of rapid-acting insulin analogue aiming to produce minor hypoglycaemia based on insulin to carbohydrate ratio will be injected subcutaneously. Arterialized-venous sampling will be performed every 10 minutes for a period of two hours.
Samples will be analyzed for glucose using the Super GL; concomitantly, capillary measurements using the GlucoCard G Meter will be performed.
This procedure will be performed on days 2 and 4 of monitoring; each subject randomized to Procedure B undergoes this procedure twice.
| Study group | Role | What they receive |
|---|---|---|
| GlucoMenDay - Multiple sampling (A) | Experimental | Not described Receives: Device: GlucoMenDay |
| GlucoMenDay - Meal/Insulin test (B) | Experimental | Not described Receives: Device: GlucoMenDay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the GlucoMenDay
Assessed by methods such as the Clarke Error Grid Analysis (EGA), CG-EGA, MARD, MAD
Measured: 1 week
Secondary outcomes (1)
Safety of the GlucoMenDay System
Assessment of patients with local skin reaction at insertion site after 100 hours of continuous monitoring
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2010
- Study completionDec 2010
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.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Menarini Group
- Responsible party
- Principal investigator, Pieber Thomas, MD, Medical University of Graz
- Investigators
- Thomas R. Pieber, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407315
- Sponsor's protocol ID
- GMD_03
- Status last verified
- Apr 2012
- First submitted
- 23 May 2011
- Last updated
- 20 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy, Reliability and Safety of GlucoMen®Day, a New Generation Microdialysis Continuous Glucose Monitor
- ClinicalTrials.gov ID
- NCT01407315
- Acronym / sponsor ID
- GMD_03
- Conditions
- Type 1 Diabetes
- Keywords
- Continuous subcutaneous glucose monitoring, Type 1 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Menarini Group
- Study start
- Nov 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Aug 2011 (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.
Monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, equipped with the GlucoMen®Day system, over up to 100 hours observation after implantation of the microdialysis probe. Different meal/hypo procedures will be performed at the study centre.
Detailed description
This is a monocenter single-arm, prospective clinical study in 20 type 1 diabetic subjects, who will be equipped with the GlucoMen®Day system.
Each subject will be investigated for up to 100 hours after implantation of the microdialysis probe.
In order to verify the clinical effectiveness of the GlucoMenDay the subjects will be asked to perform a total of six self testing measurements per day using the GlucoCard G-Meter according to the following scheme:
- before breakfast
- before lunch
- 60-120 minutes after lunch
- before dinner
- 60-120 minutes after dinner
- at 3 AM
Subjects will be asked to come to the research facility every day to obtain a venous blood sample and to check system functioning.
Subjects will be randomized either to Procedure A - Multiple sampling or Procedure B - Meal/Insulin test.
Procedure A - Multiple sampling:
This procedure can be performed at days 2-4 of the study period. Subjects will receive a standardized lunch (100 g of CHO), administration of insulin will be performed by the subject based on insulin to carbohydrate ratio. An intravenous catheter will be inserted in one forearm and venous sampling will start 1 hour after lunch ingestion. Arterialized-venous blood sampling will be performed every 15 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly capillary measurements using the GlucoCard G Meter will be performed.
Procedure B - Meal/Insulin test:
This procedure will be performed on days 2 and four of the experiment. Subjects randomized to procedure B will be asked to undergo this investigation twice.
Subjects will receive a standard breakfast (75g CHO), the usual morning insulin dose will be post-poned. An increased dose of rapid-acting insulin analogue aiming to produce minor hypoglycaemia based on insulin to carbohydrate ratio will be injected subcutaneously. Arterialized-venous sampling will be performed every 10 minutes for a period of two hours.
Samples will be analyzed for glucose using the Super GL; concomitantly, capillary measurements using the GlucoCard G Meter will be performed.
On day 5 subjects will return to the clinical trial unit for collection of a final blood sample and removal of the device.
Subjects will be asked to come to the research facility at 48 and 72 hours after removal of the device for an evaluation of local site reactions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GlucoMenDay - Multiple sampling (A) | Experimental | Device: GlucoMenDay |
| GlucoMenDay - Meal/Insulin test (B) | Experimental | Device: GlucoMenDay |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Established diagnosis of type-1-diabetes
- Ability to provide informed consent
- Age 18-75 years
Key exclusion criteria (9 listed)
- Subjects under anti-coagulant treatments
- Alcoholism
- Body mass index (BMI) > 32 kg/m2
- Inability to adhere to the protocol or to attend the required follow- up visits and tests
- Diseases or conditions of the abdominal wall which, in the opinion of Clinician might contraindicate the insertion of the hypodermic needle into the subcutaneous tissue
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 |
|---|---|---|
| GlucoMenDayAlso: Continuous Glucose MonitoringSubjects will receive a standardized lunch (100 g of CHO), administration of insulin will be performed by the subject based on insulin to carbohydrate ratio. An intravenous catheter will be inserted in one forearm and venous sampling will start 1 hour after lunch ingestion. Arterialized-venous blood sampling will be performed every 15 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly capillary measurements using the GlucoCard G Meter will be performed. This procedure can be performed on days 3-4 of monitoring; each subject randomized to Procedure A undergoes this procedure once. | Device | GlucoMenDay - Multiple sampling (A) |
| GlucoMenDayAlso: Continuous Glucose MonitoringSubjects will receive a standard breakfast (75g CHO), the usual morning insulin dose will be post-poned. An increased dose of rapid-acting insulin analogue aiming to produce minor hypoglycaemia based on insulin to carbohydrate ratio will be injected subcutaneously. Arterialized-venous sampling will be performed every 10 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly, capillary measurements using the GlucoCard G Meter will be performed. This procedure will be performed on days 2 and 4 of monitoring; each subject randomized to Procedure B undergoes this procedure twice. | Device | GlucoMenDay - Meal/Insulin test (B) |
Primary outcome
Accuracy of the GlucoMenDay
Time frame: 1 week
Assessed by methods such as the Clarke Error Grid Analysis (EGA), CG-EGA, MARD, MAD
1 secondary outcome
Safety of the GlucoMenDay System
Time frame: 1 week
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 20 Apr 2012.
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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?
A Phase 1 study testing GlucoMenDay in people with 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 3 inclusion and 9 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 20 Apr 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Accuracy of the GlucoMenDay (time frame: 1 week). 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 20 Apr 2012.