DiabetesPhase 1NCT01135771
Performance Study Using the OptiScanner on Healthy Diabetics
A Phase 1 study testing glucose and insulin IV to alter blood glucose in people with Diabetes, run by Profil Institut für Stoffwechselforschung GmbH at 1 site in Germany.
Trial summary
This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement. The accuracy of the test device will be determined using plasma samples collected directly from Type 1 and Type 2 Diabetics using the OptiScanner. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- glucose and insulin IV to alter blood glucose
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have signed an Informed Consent Form for this study approved by the Institutional Review Board (IRB)
- Have a documented onset of diabetes ³ 1 year prior to this study
- Have Type 1 or Type 2 diabetes according to the American Diabetes Association diagnostic criteria
- Be currently treated with insulin (all regimens) for ³ 1 year and able (as judged by Investigator) and willing to undergo a hypoglycemic challenge and a hyperglycemic challenge; oral diabetes medication in combination with insulin is allowed
- Be at least 18 but no more than 65 years of age
- Be willing and able to comply with the requirements of the protocol
- Be willing to refrain from participating in any other investigational study while enrolled in this study
- For Female Subjects: Be post-menopausal, sterilized or not of child-bearing potential, or have a negative pregnancy test and have no intention of becoming pregnant between Visit 1 and Visit 2, and be using contraceptive devices or drugs (risk of pregnancy must be lower than 1%).
Who cannot join
- Recurrent major hypoglycemia (as judged by the Investigator) or hypoglycemia requiring hospitalization within the last 12 months
- Have a history of hypoglycemic seizure within the last year
- Impaired hepatic function measured as AST/ALT ³ two and a half times the upper reference limit or total bilirubin two and a half times the upper reference limit based on analysis from the local laboratory, or at the Investigator's discretion
- Impaired renal function measured as creatinine ³ 1.5 (females) mg/dL, ³ 1.7 (males) mg/dL based on analysis from the local laboratory, or at the Investigator's discretion
- Haematocrit or electrolytes (sodium, potassium) outside of normal limits based on analysis from the local laboratory, or at the investigator's discretion.
- Have Uric Acid > 10 mg/dL based on analysis from the local laboratory
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- HIV positive, or Hepatitis B or C positive (blood test required). A viral load test will be done at the local laboratory for subjects with a positive Hepatitis result.
- New York Heart Association (NYHA) Class III or IV congestive heart failure
- Have a history of angina requiring hospitalization or a myocardial infarction within the last 12 months
- Evidence of intermittent or sustained ventricular or supra-ventricular arrhythmias such as ventricular tachycardia, atrial fibrillation, etc. Holter monitoring may be performed to exclude arrhythmias at the discretion of the investigator.
- Uncontrolled treated/untreated hypertension (systolic blood pressure ³ 160 mmHg and/or diastolic blood pressure ³ 100 mmHg)
- Have active diabetic proliferative retinopathy (undergoing treatment)
- Have active significant recurring skin infections or adhesive allergies, at the Investigator's discretion
- Have given more than 150 mL of blood within 8 weeks prior to enrollment in this study
- Currently taking anticoagulants, e.g. Coumadin (warfarin), Marcumar (phenprocoumon). Patients with prolonged activated PTT will not be included in this study.
- Have received any investigational product or been treated with an invasive device within the past 30 days
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation
- Any chronic illness that, in the judgment of the Investigator, may hinder or confuse compliance with the protocol
- Any condition (may include clinically significant screening laboratory assessments) which, in the judgement of the Investigator, may increase the risk to the subject or decrease the likelihood of achieving the objectives of the study
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement. The accuracy of the test device will be determined using plasma samples collected directly from Type 1 and Type 2 Diabetics using the OptiScanner. Blood samples will simultaneously be collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated. These results will be compared to the OptiScanner's glucose measurement.
- Conditions
- Diabetes
- Being tested
- glucose and insulin IV to alter blood glucose
- Keywords
- glucose monitoring, diabetes, glucose monitoring in patients with diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose and insulin IV to alter blood glucoseOther
What is being measured
The primary outcome is the main question the study is designed to answer.
demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in otherwise healthy diabetic subjects when compared to blood glucose levels simultaneously measured on the YSI
Secondary outcomes (1)
The secondary objective of the study is to demonstrate a blood glucose measurement range of 60 to 500 mg/dL at the hematocrit levels referenced as normal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- OptiScan Biomedical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135771
- Sponsor's protocol ID
- 1003106
- Status last verified
- Jun 2010
- First submitted
- 2 Jun 2010
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Study Using the OptiScanner on Healthy Diabetics
- ClinicalTrials.gov ID
- NCT01135771
- Acronym / sponsor ID
- 1003106
- Conditions
- Diabetes
- Keywords
- glucose monitoring, diabetes, glucose monitoring in patients with diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- OptiScan Biomedical Corporation
- Study start
- Nov 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Jun 2010 (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.
This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement. The accuracy of the test device will be determined using plasma samples collected directly from Type 1 and Type 2 Diabetics using the OptiScanner. Blood samples will simultaneously be collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated. These results will be compared to the OptiScanner's glucose measurement.
Study design
- Primary purpose
- Diagnosis
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have signed an Informed Consent Form for this study approved by the Institutional Review Board (IRB)
- Have a documented onset of diabetes ³ 1 year prior to this study
- Have Type 1 or Type 2 diabetes according to the American Diabetes Association diagnostic criteria
- Be currently treated with insulin (all regimens) for ³ 1 year and able (as judged by Investigator) and willing to undergo a hypoglycemic challenge and a hyperglycemic challenge; oral diabetes medication in combination with insulin is allowed
- Be at least 18 but no more than 65 years of age
Key exclusion criteria (20 listed)
- Recurrent major hypoglycemia (as judged by the Investigator) or hypoglycemia requiring hospitalization within the last 12 months
- Have a history of hypoglycemic seizure within the last year
- Impaired hepatic function measured as AST/ALT ³ two and a half times the upper reference limit or total bilirubin two and a half times the upper reference limit based on analysis from the local laboratory, or at the Investigator's discretion
- Impaired renal function measured as creatinine ³ 1.5 (females) mg/dL, ³ 1.7 (males) mg/dL based on analysis from the local laboratory, or at the Investigator's discretion
- Haematocrit or electrolytes (sodium, potassium) outside of normal limits based on analysis from the local laboratory, or at the investigator's discretion.
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 |
|---|---|---|
| glucose and insulin IV to alter blood glucose | Other | – |
Primary outcome
demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in otherwise healthy diabetic subjects when compared to blood glucose levels simultaneously measured on the YSI
1 secondary outcome
The secondary objective of the study is to demonstrate a blood glucose measurement range of 60 to 500 mg/dL at the hematocrit levels referenced as normal
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 3 Jun 2010.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 glucose and insulin IV to alter blood glucose in people with Diabetes, 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 8 inclusion and 20 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 3 Jun 2010. 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.
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?
demonstrate the accuracy of the OptiScanner in measuring blood glucose levels in otherwise healthy diabetic subjects when compared to blood glucose levels simultaneously measured on the YSI. 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 3 Jun 2010.