DiabetesNCT01645696
Three-day, In-clinic Evaluation of the BD 2nd Generation Continuous Glucose Sensor Device in Type 1 Diabetics
A study testing BD CGM with Outer Layer, BD CGM without Outer Layer and Medtronic iPro2 Professional CGM in people with Diabetes, run by Becton, Dickinson and Company at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the accuracy and performance of a new subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high blood sugar) and hypoglycemic (low blood sugar) "clamp" conditions and during meal excursions over the course of 72 hours as compared to a… 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 CGM with Outer Layer, BD CGM without Outer Layer and Medtronic iPro2 Professional CGM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Sep 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of type 1 diabetes mellitus for ≥1 year. For an individual to be enrolled at least one criterion from each list must be met.
- Criteria for documented hyperglycemia (at least 1 must be met):
- Fasting glucose ≥ 7 mmol/L [126 mg/dL] - confirmed
- Two-hour OGTT (oral glucose tolerance test) glucose ≥ 11.1 mmol/L [200 mg/dL] - confirmed
- HbA1c ≥6.5% documented - confirmed
- Random glucose ≥ 11.1 mmol/L [200 mg/dL] with symptoms
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- No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- Criteria for requiring insulin at diagnosis (1 must be met):
- Participant required insulin at diagnosis and continually thereafter
- Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually
- Participant did not start insulin at diagnosis but continued to be hyperglycemic, had positive islet cell antibodies - consistent with latent autoimmune diabetes in adults (LADA) and did require insulin eventually and used continually
- Signed informed consent
- Age ≥18 and ≤65 years old
- Body mass index between 19 and 35 kg/m2, inclusive
- HbA1c ≤ 10.0%
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 or aspartate aminotransferase ≥ three times the upper reference limit
- Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal
- Diabetic ketoacidosis in the past 6 months
- Severe hypoglycemia resulting in a seizure or loss of consciousness in the 6 months prior to enrollment
- Conditions which may increase the risk of hypoglycemia or conditions of known microvascular (diabetic) complications will be assessed on an individual basis with exclusion based on the discretion of the principal investigator.
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- Current use of medications containing > 4000 mg acetaminophen per day.
- Current use of MAO (monoamine oxidase) inhibitors.
- Known allergy to eggs
- Pregnancy, breast-feeding or intention of becoming pregnant
- Current or recent alcohol or drug abuse by subject history.
- Blood donation of more than 473 ml within the last 56 days
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Any skin condition that prevents sensor placement on the abdomen (e.g., bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
- Known allergy to medical adhesives, e.g. Tegaderm
- Hematocrit < 38% (males) and < 36% (females)
- Potassium < 3.4 mmol/L
- Active enrollment in another clinical trial
Trial locations and contacts
1 site in 1 country.
Canada1 site
>LMC Endocrinology Centre, Clinical Research Unit
Toronto, Ontario, M4G 3E8
About this study
Official title: Three-day, In-clinic, Clamp Evaluation of the BD 2nd Generation Continuous Glucose Sensor in Subjects With Type 1 Diabetes
The purpose of this study is to investigate the accuracy and performance of a new subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high blood sugar) and hypoglycemic (low blood sugar) "clamp" conditions and during meal excursions over the course of 72 hours as compared to a commercially available monitor.
Read the detailed description
This is a single site, non-randomized study. The study consists of a Screening Visit (Visit 1) during which the subject will be consented and the inclusion exclusion criteria confirmed. An interventional visit (Visit 2)which consists of a 72 hour in-clinic stay and a Follow-up Visit (Visit 3). Subjects eligible for the study will be admitted to the clinic for the Study Visit 2 in the afternoon on the day before the first Clamp is performed. An IV line for blood sampling will be established. One blood sample will be obtained for glucose determination and a second blood sample will be collected for immunoassay development before any sensors are inserted. Two BD-Glucose Binding Protein-Continuous Glucose Monitor Sensors(BD-GBP-CGM), with and without outer layer, and one commercial CGM sensor will be inserted in the subcutaneous tissue in the abdomen shortly thereafter. Blood sampling intervals will be adjusted over the 3 study days as determined by the study event (i.e. clamp period, meal excursion, nighttime). During the hyper- /hypo-glycemic clamps periods on Day 1 and Day 3 blood samples will be taken more frequently, every 5-10 minutes. During the breakfast meal on Day 2 sampling will occur at 10-15 minute intervals for 4 hours to capture the meal excursion. Sampling will be less frequent during the evening meal and at night during sleep hours.
- Conditions
- Diabetes
- Being tested
- BD CGM with Outer Layer, BD CGM without Outer Layer, Medtronic iPro2 Professional CGM
- Keywords
- Diabetes, Type 1 Diabetes, Continuous glucose monitoring, Blood glucose, Blood glucose sensor, Glucose Binding Protein (GBP)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD CGM with Outer LayerDevice
continuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours.
BD CGM without Outer LayerDevice
continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.
Medtronic iPro2 Professional CGMDevice
continuous subcutaneous glucose monitoring for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| BD Continuous Glucose Monitor (CGM) with outer layer | Experimental | A subcutaneous glucose binding protein sensing device to continuously monitor glucose in diabetics. Receives: Device: BD CGM with Outer Layer |
| BD CGM without outer layer | Experimental | A continuous glucose binding protein sensing device used to monitor glucose in Diabetics Receives: Device: BD CGM without Outer Layer |
| Medtronic iPro 2 Professional CGM | Active comparator | Commercial glucose oxidase continuous glucose monitor Receives: Device: Medtronic iPro2 Professional CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Blood glucose will be measured by the BD-Continuous Glucose Monitor, with and without outer layer, the commercially available Medtronic iPro2 and the YSI (Yellow Springs Instrument) Glucose analyzer (control) for 72 hours. Blood glucose will be used to determine performance of the device to include warm up behavior, lag time and accuracy of the blood glucose monitor over 72 hours.
Measured: 72 hours
Number of participants with adverse events
At each study contact, subjects will be questioned about any adverse events that may have occurred and are potentially related to the device.
Measured: up to 89 days or until the subject is discharged
Secondary outcomes (4)
Skin Effects-Draize Scoring for Skin Irritation
Local reaction at insertion sites will be scored for redness and swelling at the following timepoints: Visit 2-pre-insertion of devices, immediately post insertion of the devices, each morning of Day 1, 2 and 3, immediately after removal of the devices and at Visit 3.
Measured: Up to 36 days
Skin thickness using ultrasound
Skin thickness will be measured at the sensor sites and a control site (on the abdomen) immediately after removal of the device.
Measured: Upon removal of the devices
Insulin levels
Blood samples will be taken at pre-determined times following insulin dosings to test for insulin levels:
Measured: 72 hours
antibodies against the glucose binding protein
A blood sample will be taken at the beginning of Visit 2 and at Visit 3 to test for antibody production following exposure to the sensor's glucose binding protein.
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionSep 2012
- Study completionSep 2012
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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronnie Aronson, MD, Principal investigator, LMC Endocrinology Centre, Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645696
- Sponsor's protocol ID
- BDT-11-CGM002
- Status last verified
- Dec 2021
- First submitted
- 13 Jul 2012
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-day, In-clinic, Clamp Evaluation of the BD 2nd Generation Continuous Glucose Sensor in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01645696
- Acronym / sponsor ID
- BDT-11-CGM002
- Conditions
- Diabetes
- Keywords
- Diabetes, Type 1 Diabetes, Continuous glucose monitoring, Blood glucose, Blood glucose sensor, Glucose Binding Protein (GBP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Jul 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.
The purpose of this study is to investigate the accuracy and performance of a new subcutaneous continuous glucose monitor (BD-CGM, Becton Dickinson) in hyperglycemic (high blood sugar) and hypoglycemic (low blood sugar) "clamp" conditions and during meal excursions over the course of 72 hours as compared to a commercially available monitor.
Detailed description
This is a single site, non-randomized study. The study consists of a Screening Visit (Visit 1) during which the subject will be consented and the inclusion exclusion criteria confirmed. An interventional visit (Visit 2)which consists of a 72 hour in-clinic stay and a Follow-up Visit (Visit 3). Subjects eligible for the study will be admitted to the clinic for the Study Visit 2 in the afternoon on the day before the first Clamp is performed. An IV line for blood sampling will be established. One blood sample will be obtained for glucose determination and a second blood sample will be collected for immunoassay development before any sensors are inserted. Two BD-Glucose Binding Protein-Continuous Glucose Monitor Sensors(BD-GBP-CGM), with and without outer layer, and one commercial CGM sensor will be inserted in the subcutaneous tissue in the abdomen shortly thereafter. Blood sampling intervals will be adjusted over the 3 study days as determined by the study event (i.e. clamp period, meal excursion, nighttime). During the hyper- /hypo-glycemic clamps periods on Day 1 and Day 3 blood samples will be taken more frequently, every 5-10 minutes. During the breakfast meal on Day 2 sampling will occur at 10-15 minute intervals for 4 hours to capture the meal excursion. Sampling will be less frequent during the evening meal and at night during sleep hours.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BD Continuous Glucose Monitor (CGM) with outer layer | Experimental | Device: BD CGM with Outer LayerA subcutaneous glucose binding protein sensing device to continuously monitor glucose in diabetics. |
| BD CGM without outer layer | Experimental | Device: BD CGM without Outer LayerA continuous glucose binding protein sensing device used to monitor glucose in Diabetics |
| Medtronic iPro 2 Professional CGM | Active comparator | Device: Medtronic iPro2 Professional CGMCommercial glucose oxidase continuous glucose monitor |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Clinical diagnosis of type 1 diabetes mellitus for ≥1 year. For an individual to be enrolled at least one criterion from each list must be met.
- Criteria for documented hyperglycemia (at least 1 must be met):
- Criteria for requiring insulin at diagnosis (1 must be met):
- Signed informed consent
- Age ≥18 and ≤65 years old
Key exclusion criteria (18 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 or aspartate aminotransferase ≥ three times the upper reference limit
- Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal
- Diabetic ketoacidosis in the past 6 months
- Severe hypoglycemia resulting in a seizure or loss of consciousness in the 6 months prior to enrollment
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 CGM with Outer Layercontinuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours. | Device | BD Continuous Glucose Monitor (CGM) with outer layer |
| BD CGM without Outer Layercontinuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours. | Device | BD CGM without outer layer |
| Medtronic iPro2 Professional CGMcontinuous subcutaneous glucose monitoring for 72 hours | Device | Medtronic iPro 2 Professional CGM |
Primary outcome
Blood Glucose
Time frame: 72 hours
Blood glucose will be measured by the BD-Continuous Glucose Monitor, with and without outer layer, the commercially available Medtronic iPro2 and the YSI (Yellow Springs Instrument) Glucose analyzer (control) for 72 hours. Blood glucose will be used to determine performance of the device to include warm up behavior, lag time and accuracy of the blood glucose monitor over 72 hours.
Number of participants with adverse events
Time frame: up to 89 days or until the subject is discharged
At each study contact, subjects will be questioned about any adverse events that may have occurred and are potentially related to the device.
4 secondary outcomes
Skin Effects-Draize Scoring for Skin Irritation
Time frame: Up to 36 days
Skin thickness using ultrasound
Time frame: Upon removal of the devices
Insulin levels
Time frame: 72 hours
antibodies against the glucose binding protein
Time frame: 36 days
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 29 Dec 2021.
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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.
Ronnie Aronson, MD principal investigator
LMC Endocrinology Centre, Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD CGM with Outer Layer, BD CGM without Outer Layer and Medtronic iPro2 Professional CGM in people with Diabetes, run by Becton, Dickinson and Company at 1 site in Canada.
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 15 inclusion and 18 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 29 Dec 2021. 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 Canada. 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?
Blood Glucose (time frame: 72 hours). The study lists 2 primary outcomes in all. 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 29 Dec 2021.