Type 1 Diabetes MellitusPhase 2SMA002NCT01469715
A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)
A Phase 2 study testing GBP CGM in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (>180mg/dL) glucose levels over a 24 hour period. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- GBP CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 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 ≥126 mg/dL - confirmed
- Two-hour oral Glucose Tolerance Tests (OGTT) glucose ≥200 mg/dL - confirmed
- HbA1c ≥6.5% documented - confirmed
- Random glucose ≥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
- Use of an insulin pump to treat his or her diabetes for at least six months prior to the study.
- Actively using a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal(s), carbohydrate ratio(s), and insulin sensitivity factor(s).
- Signed informed consent
- Age ≥21 and <65 years old
- 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 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 12 months prior to enrollment
- Conditions which may increase the risk of induced hypoglycemia such as known coronary artery disease, congestive heart failure, history of any cardiac disorder or arrhythmia, history of a cerebrovascular event, history of migraines, seizure disorder, syncope, adrenal insufficiency, or neurological disease.
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- Current use of medications containing >4000 mg acetaminophen per day.
- Current use of L-Monoamine oxidases (MAO) inhibitors.
- Known microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy),such as history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy (other than microalbuminuria with normal creatinine) or neuropathy requiring treatment
- Known allergy to eggs
- Pregnancy, breast-feeding or intention of becoming pregnant
- Current or recent alcohol or drug abuse by patient history.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: A Clinical Study of the Warm-Up, Accuracy, and Lag Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)
The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (>180mg/dL) glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing 41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and displays blood sugar (glucose) levels in the body throughout the day and night. The method being used to detect blood sugar in the investigational Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by commercially available models.
Some sensors cannot tell the difference between glucose (sugar) and other substances such as Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give false readings. The GBP CGM is made to only recognize glucose in the body rather than other substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect the new GBP CGM to be more accurate at detecting low blood sugar levels than the current devices.
Read the detailed description
Development of accurate continuous glucose monitoring devices is critically important for the maintenance of strict glycemic control without increasing the risk for hypoglycemia and for the successful implementation of an artificial pancreas. Glucose binding protein-based (GBP) continuous glucose monitors offer several potential advantages over commercially available glucose oxidase based sensors. Unlike glucose oxidase based sensors, GBP sensors do not require establishment of an equilibrium reduction/oxidation reaction and are not as susceptible to interference from other compounds because they are engineered to recognize only glucose. As a result, GBP-based glucose sensors are exceptionally accurate at low blood glucose levels and have a faster warm-up time than glucose oxidase based systems. The principal idea of this proposal is to evaluate the accuracy and performance of a second generation glucose binding protein-based continuous glucose monitor (GBP CGM) developed by BD Technologies in subjects with type 1 diabetes, with emphasis on warm-up period after insertion, accuracy in hypoglycemic and hyperglycemic ranges, and lag time over a 24 hour period of sensor use. In order to accomplish this, the investigators will conduct a clinical trial consisting of 25.5-hour studies involving 15 subjects, each wearing one active and one mock (no GBP) device simultaneously during meals and induced hypoglycemia to observe a wide range of glucose values. The investigators envision that the glucose binding protein-based continuous glucose monitor will demonstrate minimal warm-up time after insertion, overall accuracy comparable to commercial glucose oxidase sensors with excellent performance in the hypoglycemic range and a nominal lag time to sensing a change in blood glucose.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- GBP CGM
- Keywords
- Continuous Glucose Monitor
- 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.
GBP CGMDevice
Also called Glucose binding protein-based continuous glucose monitor
Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active \& one mock device simultaneously during hyperglycemic \& hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 \& 4: Subjects will return to the research center approximately 24 \& 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 \& 5.
| Study group | Role | What they receive |
|---|---|---|
| GBP-CGM | Experimental | All participants will wear one active GBP-CGM and one inactive GBP-CGM Receives: Device: GBP CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Relative Difference (ARD)
ARD=100*(G_sensor-G_reference)/G_reference
Calculated for when patient's G_ref was Normal (70-180 mg/dl), Hyperglycemic (>180 mg/dl) and Hypoglycemic (<70 mg/dl)
The study data includes 208 paired sensor-YSI plasma glucose readings (G_reference) for each GBP CGM sensor (G_sensor) inserted for 24 hours during hyperglycemic and hypoglycemic challenge conditions. Data pairs will permit the detailed evaluation of sensor performance parameters, including static accuracy metrics such as median and mean absolute deviations and median and mean absolute relative deviation and Point CG-EGA, as well as dynamic parameters, such as warm-up time, trend accuracy (Rate CG-EGA), and sensor lag.
Measured: 25.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Becton, Dickinson and Company
- Responsible party
- Principal investigator, Stacey Anderson, University of Virginia
- Investigators
- Stacey Anderson, MD, Principal investigator, University of Virginia, Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469715
- Sponsor's protocol ID
- 15696
- Acronym
- SMA002
- Status last verified
- Jul 2015
- First submitted
- 7 Nov 2011
- Last updated
- 31 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Warm-Up, Accuracy, and Lag Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)
- ClinicalTrials.gov ID
- NCT01469715
- Acronym / sponsor ID
- SMA002 / 15696
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Continuous Glucose Monitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation, Becton, Dickinson and Company
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Posted 31 Jul 2015
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 assess the accuracy of the Becton Dickenson (BD) Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (>180mg/dL) glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing 41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and displays blood sugar (glucose) levels in the body throughout the day and night. The method being used to detect blood sugar in the investigational Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by commercially available models.
Some sensors cannot tell the difference between glucose (sugar) and other substances such as Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give false readings. The GBP CGM is made to only recognize glucose in the body rather than other substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect the new GBP CGM to be more accurate at detecting low blood sugar levels than the current devices.
Detailed description
Development of accurate continuous glucose monitoring devices is critically important for the maintenance of strict glycemic control without increasing the risk for hypoglycemia and for the successful implementation of an artificial pancreas. Glucose binding protein-based (GBP) continuous glucose monitors offer several potential advantages over commercially available glucose oxidase based sensors. Unlike glucose oxidase based sensors, GBP sensors do not require establishment of an equilibrium reduction/oxidation reaction and are not as susceptible to interference from other compounds because they are engineered to recognize only glucose. As a result, GBP-based glucose sensors are exceptionally accurate at low blood glucose levels and have a faster warm-up time than glucose oxidase based systems. The principal idea of this proposal is to evaluate the accuracy and performance of a second generation glucose binding protein-based continuous glucose monitor (GBP CGM) developed by BD Technologies in subjects with type 1 diabetes, with emphasis on warm-up period after insertion, accuracy in hypoglycemic and hyperglycemic ranges, and lag time over a 24 hour period of sensor use. In order to accomplish this, the investigators will conduct a clinical trial consisting of 25.5-hour studies involving 15 subjects, each wearing one active and one mock (no GBP) device simultaneously during meals and induced hypoglycemia to observe a wide range of glucose values. The investigators envision that the glucose binding protein-based continuous glucose monitor will demonstrate minimal warm-up time after insertion, overall accuracy comparable to commercial glucose oxidase sensors with excellent performance in the hypoglycemic range and a nominal lag time to sensing a change in blood glucose.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GBP-CGM | Experimental | Device: GBP CGMAll participants will wear one active GBP-CGM and one inactive GBP-CGM |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 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):
- Use of an insulin pump to treat his or her diabetes for at least six months prior to the study.
- Actively using a bolus calculator function with the current insulin pump with pre-defined parameters for glucose goal(s), carbohydrate ratio(s), and insulin sensitivity factor(s).
Key exclusion criteria (12 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 12 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 |
|---|---|---|
| GBP CGMAlso: Glucose binding protein-based continuous glucose monitorVisit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active \& one mock device simultaneously during hyperglycemic \& hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 \& 4: Subjects will return to the research center approximately 24 \& 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 \& 5. | Device | GBP-CGM |
Primary outcome
Absolute Relative Difference (ARD)
Time frame: 25.5 hours
ARD=100*(G_sensor-G_reference)/G_reference Calculated for when patient's G_ref was Normal (70-180 mg/dl), Hyperglycemic (>180 mg/dl) and Hypoglycemic (<70 mg/dl) The study data includes 208 paired sensor-YSI plasma glucose readings (G_reference) for each GBP CGM sensor (G_sensor) inserted for 24 hours during hyperglycemic and hypoglycemic challenge conditions. Data pairs will permit the detailed evaluation of sensor performance parameters, including static accuracy metrics such as median and mean absolute deviations and median and mean absolute relative deviation and Point CG-EGA, as well as dynamic parameters, such as warm-up time, trend accuracy (Rate CG-EGA), and sensor lag.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stacey Anderson, MD principal investigator
University of Virginia, Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GBP CGM in people with Type 1 Diabetes Mellitus, run by University of Virginia 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 17 inclusion and 12 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 31 Jul 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Relative Difference (ARD) (time frame: 25.5 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 31 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.