Three-day, In-clinic Evaluation of the BD 2nd Generation Continuous Glucose Sensor Device in Type 1 Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01645696
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : April 22, 2013
Information provided by (Responsible Party):
Becton, Dickinson and Company

Brief 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 commercially available monitor.

Condition or disease Intervention/treatment Phase
Diabetes Device: BD CGM with Outer Layer Device: BD CGM without Outer Layer Device: Medtronic iPro2 Professional CGM Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Three-day, In-clinic, Clamp Evaluation of the BD 2nd Generation Continuous Glucose Sensor in Subjects With Type 1 Diabetes
Study Start Date : June 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BD Continuous Glucose Monitor (CGM) with outer layer
A subcutaneous glucose binding protein sensing device to continuously monitor glucose in diabetics.
Device: BD CGM with Outer Layer
continuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours.
Experimental: BD CGM without outer layer
A continuous glucose binding protein sensing device used to monitor glucose in Diabetics
Device: BD CGM without Outer Layer
continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.
Active Comparator: Medtronic iPro 2 Professional CGM
Commercial glucose oxidase continuous glucose monitor
Device: Medtronic iPro2 Professional CGM
continuous subcutaneous glucose monitoring for 72 hours

Primary Outcome Measures :
  1. 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 characteristics to include warm up behavior, lag time and accuracy over 72 hours

  2. 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

Secondary Outcome Measures :
  1. Skin Effects-Draize Scoring for Skin Irritation [ Time Frame: Up to 36 days ]
    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.

  2. Skin thickness using ultrasound [ Time Frame: Upon removal of the devices ]
    Skin thickness will be measured at the sensor sites and a control site (on the abdomen) immediately after removal of the device.

  3. Insulin levels [ Time Frame: 72 hours ]
    Blood samples will be taken at pre-determined times following insulin dosings to test for insulin levels:

  4. antibodies against the glucose binding protein [ Time Frame: 36 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.
  2. Criteria for documented hyperglycemia (at least 1 must be met):

    1. Fasting glucose ≥ 7 mmol/L [126 mg/dL] - confirmed
    2. Two-hour OGTT (oral glucose tolerance test) glucose ≥ 11.1 mmol/L [200 mg/dL] - confirmed
    3. HbA1c ≥6.5% documented - confirmed
    4. Random glucose ≥ 11.1 mmol/L [200 mg/dL] with symptoms
    5. No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
  3. Criteria for requiring insulin at diagnosis (1 must be met):

    1. Participant required insulin at diagnosis and continually thereafter
    2. 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
    3. 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
  4. Signed informed consent
  5. Age ≥18 and ≤65 years old
  6. Body mass index between 19 and 35 kg/m2, inclusive
  7. HbA1c ≤ 10.0%

Exclusion Criteria:

  1. Uncontrolled arterial hypertension (diastolic blood pressure > 90 mm Hg and/or systolic blood pressure > 160 mm Hg)
  2. Impaired hepatic function measured as alanine aminotransferase or aspartate aminotransferase ≥ three times the upper reference limit
  3. Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal
  4. Diabetic ketoacidosis in the past 6 months
  5. Severe hypoglycemia resulting in a seizure or loss of consciousness in the 6 months prior to enrollment
  6. 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.
  7. Current use of medications containing > 4000 mg acetaminophen per day.
  8. Current use of MAO (monoamine oxidase) inhibitors.
  9. Known allergy to eggs
  10. Pregnancy, breast-feeding or intention of becoming pregnant
  11. Current or recent alcohol or drug abuse by subject history.
  12. Blood donation of more than 473 ml within the last 56 days
  13. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  14. Any skin condition that prevents sensor placement on the abdomen (e.g., bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
  15. Known allergy to medical adhesives, e.g. Tegaderm
  16. Hematocrit < 38% (males) and < 36% (females)
  17. Potassium < 3.4 mmol/L
  18. Active enrollment in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01645696

Canada, Ontario
>LMC Endocrinology Centre, Clinical Research Unit
Toronto, Ontario, Canada, M4G 3E8
Sponsors and Collaborators
Becton, Dickinson and Company
Principal Investigator: Ronnie Aronson, MD LMC Endocrinology Centre, Clinical Research Unit

Responsible Party: Becton, Dickinson and Company Identifier: NCT01645696     History of Changes
Other Study ID Numbers: BDT-11-CGM002
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: April 22, 2013
Last Verified: April 2013

Keywords provided by Becton, Dickinson and Company:
Type 1 Diabetes
Continuous glucose monitoring
Blood glucose
Blood glucose sensor
Glucose Binding Protein (GBP)