DiabetesPhase 1NCT01093833
A Comparison Study of Prototype Continuous Glucose Sensors in the Intradermal and Subcutaneous Spaces
A Phase 1 study testing BD Continuous glucose monitor (BD CGM), YSI Glucose Analyzer and Medtronic Guardian CGM in people with Diabetes, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
The purpose of this study is to compare two continuous glucose sensors, one placed subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes
- What is being tested?
- BD Continuous glucose monitor (BD CGM), YSI Glucose Analyzer and Medtronic Guardian CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2009
- 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
- Otherwise healthy male and female subjects with Type 1 or Type 2 diabetes mellitus
- Signed informed consent
- Age between 18 and 65 years, inclusive
- Body mass index between 19 and 30 kg/m², inclusive
- HbA1c < 11 %
Who cannot join
- Uncontrolled arterial hypertension (diastolic blood pressure >90 mm Hg and/or systolic blood pressure >160 mm Hg)
- Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit
- Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal.
- Severe acute diseases, i.e. cardiac, pulmonary, gastrointestinal, hepatic, neurologic, or infectious that might interfere with the performance of this study, as judged by the Investigator.
- Severe chronic diseases, as judged by the investigator other than Type 1 Diabetes
- Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
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- Known microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as e.g. history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy or neuropathy requiring treatment
- Positive serology for Hepatitis B, Hepatitis C or HIV
- Pregnancy, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures.
- Known current or recent alcohol or drug abuse
- Blood donation of more than 500 ml within the last three months
- Anticoagulant therapy
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
- Previous participation in a study involving the GBP-based sensor
- Has taken more than 4000 mg or more of acetaminophen within the past 24 hours (i.e. 13 or more regular strength or 8 or more extra strength Tylenol in the past 24 hours)
- Any skin condition that may be judged to have affect on study ( e.g., bad sunburn, pre-existing dermatitis)
Trial locations and contacts
1 site in 1 country.
United States1 site
Profil Institute for Clinical Research Inc
Chula Vista, California, 91911
About this study
The purpose of this study is to compare two continuous glucose sensors, one placed subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours.
Read the detailed description
This was a single site, non-randomized study. The study consisted of a screening visit (Visit 1), during which the subject was consented and the inclusion and exclusion criteria confirmed, an experimental intervention (Visit 2) and a follow-up visit (Visit 3). The experimental intervention was based on an initial glucose clamp involving a basal intravenous (IV) insulin infusion and IV insulin boluses plus IV glucose infusion / IV glucose boluses as required to maintain euglycemic, hypoglycemic and hyperglycemic plateaus respectively in 41 subjects with Type 1 or Type 2 Diabetes. At the end of hour five of the study the glucose clamp was discontinued and subjects given a standardized meal to stimulate a hyperglycemic excursion
Each subject participated in one experimental intervention. During the glucose clamp intervention, the subject's blood glucose was continuously monitored either by means of the Biostator or by frequent venous blood glucose measurements based on a standard lab method (YSI STAT2300 analyzer), and measured by means of the BD Technologies test devices, and the Medtronic Guardian CGM. Once the clamp was discontinued the Biostator was discontinued as well. During the unclamped period and meal the subjects BG was monitored via the YSI Glucose Analyzer, the BD CGM sensor and the Medtronic Guardian CGM.
- Conditions
- Diabetes
- Being tested
- BD Continuous glucose monitor (BD CGM), YSI Glucose Analyzer, Medtronic Guardian CGM
- Keywords
- Diabetes, Type 1 diabetes, Type 2 diabetes, Diabetes mellitus, Blood glucose, Continuous blood glucose monitoring, CGM
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Continuous glucose monitor (BD CGM)Device
Also called MiniMed Guardian CGM
Continuous glucose monitoring for 12-14 hours
YSI Glucose AnalyzerDevice
Continuous glucose monitoring for 12-14 hours
Medtronic Guardian CGMDevice
Continuous glucose monitoring for 12-14 hours
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring | Experimental | Each subject will participate in one experimental intervention. Blood glucose will be measured with the BD continuous glucose monitor (BD CGM), with the Medtronic Guardian CGM and the YSI Glucose Analyzer as controls for 12-14 hours. Receives: Device: BD Continuous glucose monitor (BD CGM); Device: YSI Glucose Analyzer; Device: Medtronic Guardian CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Measured: 12-14 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Morrow Linda, MD, Principal investigator, Profil Insitute for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093833
- Sponsor's protocol ID
- BDT-08-CGM-02
- Status last verified
- May 2016
- First submitted
- 25 Mar 2010
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Judge K, Morrow L, Lastovich AG, Kurisko D, Keith SC, Hartsell J, Roberts B, McVey E, Weidemaier K, Win K, Hompesch M. Continuous glucose monitoring using a novel glucose/galactose binding protein: results of a 12-hour feasibility study with the becton dickinson glucose/galactose binding protein sensor. Diabetes Technol Ther. 2011 Mar;13(3):309-17. doi: 10.1089/dia.2010.0130. Epub 2011 Feb 7.
PubMed 21299393
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Prototype Continuous Glucose Sensors in the Intradermal and Subcutaneous Spaces
- ClinicalTrials.gov ID
- NCT01093833
- Acronym / sponsor ID
- BDT-08-CGM-02
- Conditions
- Diabetes
- Keywords
- Diabetes, Type 1 diabetes, Type 2 diabetes, Diabetes mellitus, Blood glucose, Continuous blood glucose monitoring, CGM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 26 Mar 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.
The purpose of this study is to compare two continuous glucose sensors, one placed subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours.
Detailed description
This was a single site, non-randomized study. The study consisted of a screening visit (Visit 1), during which the subject was consented and the inclusion and exclusion criteria confirmed, an experimental intervention (Visit 2) and a follow-up visit (Visit 3). The experimental intervention was based on an initial glucose clamp involving a basal intravenous (IV) insulin infusion and IV insulin boluses plus IV glucose infusion / IV glucose boluses as required to maintain euglycemic, hypoglycemic and hyperglycemic plateaus respectively in 41 subjects with Type 1 or Type 2 Diabetes. At the end of hour five of the study the glucose clamp was discontinued and subjects given a standardized meal to stimulate a hyperglycemic excursion
Each subject participated in one experimental intervention. During the glucose clamp intervention, the subject's blood glucose was continuously monitored either by means of the Biostator or by frequent venous blood glucose measurements based on a standard lab method (YSI STAT2300 analyzer), and measured by means of the BD Technologies test devices, and the Medtronic Guardian CGM. Once the clamp was discontinued the Biostator was discontinued as well. During the unclamped period and meal the subjects BG was monitored via the YSI Glucose Analyzer, the BD CGM sensor and the Medtronic Guardian CGM.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring | Experimental | Device: BD Continuous glucose monitor (BD CGM), Device: YSI Glucose Analyzer, Device: Medtronic Guardian CGMEach subject will participate in one experimental intervention. Blood glucose will be measured with the BD continuous glucose monitor (BD CGM), with the Medtronic Guardian CGM and the YSI Glucose Analyzer as controls for 12-14 hours. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Otherwise healthy male and female subjects with Type 1 or Type 2 diabetes mellitus
- Signed informed consent
- Age between 18 and 65 years, inclusive
- Body mass index between 19 and 30 kg/m², inclusive
- HbA1c < 11 %
Key exclusion criteria (16 listed)
- Uncontrolled arterial hypertension (diastolic blood pressure >90 mm Hg and/or systolic blood pressure >160 mm Hg)
- Impaired hepatic function measured as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit
- Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal.
- Severe acute diseases, i.e. cardiac, pulmonary, gastrointestinal, hepatic, neurologic, or infectious that might interfere with the performance of this study, as judged by the Investigator.
- Severe chronic diseases, as judged by the investigator other than Type 1 Diabetes
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 |
|---|---|---|
| BD Continuous glucose monitor (BD CGM)Also: MiniMed Guardian CGMContinuous glucose monitoring for 12-14 hours | Device | Continuous Glucose Monitoring |
| YSI Glucose AnalyzerContinuous glucose monitoring for 12-14 hours | Device | Continuous Glucose Monitoring |
| Medtronic Guardian CGMContinuous glucose monitoring for 12-14 hours | Device | Continuous Glucose Monitoring |
Primary outcome
Blood Glucose
Time frame: 12-14 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 6 May 2016.
- Derived from this study: PubMed 21299393Judge K, Morrow L, Lastovich AG, Kurisko D, Keith SC, Hartsell J, Roberts B, McVey E, Weidemaier K, Win K, Hompesch M. Continuous glucose monitoring using a novel glucose/galactose binding protein: results of a 12-hour feasibility study with the becton dickinson glucose/galactose binding protein sensor. Diabetes Technol Ther. 2011 Mar;13(3):309-17. doi: 10.1089/dia.2010.0130. Epub 2011 Feb 7.
- Individual participant dataSharing planned: No
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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.
Morrow Linda, MD principal investigator
Profil Insitute for Clinical Research
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 BD Continuous glucose monitor (BD CGM), YSI Glucose Analyzer and Medtronic Guardian CGM in people with Diabetes, run by Becton, Dickinson and Company at 1 site in United States.
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 16 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 6 May 2016. 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 United States. 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?
Blood Glucose (time frame: 12-14 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01093833, which also lists 1 linked publication.
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 6 May 2016.