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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Becton, Dickinson and Company
ClinicalTrials.gov Identifier:
NCT01645696
First received: July 13, 2012
Last updated: April 19, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Diabetes
Device: BD CGM with Outer Layer
Device: BD CGM without Outer Layer
Device: Medtronic iPro2 Professional CGM
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Becton, Dickinson and Company:

Primary Outcome Measures:
  • Blood Glucose [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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

  • Number of participants with adverse events [ Time Frame: up to 89 days or until the subject is discharged ] [ Designated as safety issue: Yes ]
    At each study contact, subjects will be questioned about any adverse events that may have occurred


Secondary Outcome Measures:
  • Skin Effects-Draize Scoring for Skin Irritation [ Time Frame: Up to 36 days ] [ Designated as safety issue: No ]
    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.

  • Skin thickness using ultrasound [ Time Frame: Upon removal of the devices ] [ Designated as safety issue: No ]
    Skin thickness will be measured at the sensor sites and a control site (on the abdomen) immediately after removal of the device.

  • Insulin levels [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Blood samples will be taken at pre-determined times following insulin dosings to test for insulin levels:

  • antibodies against the glucose binding protein [ Time Frame: 36 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01645696

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

No publications provided

Responsible Party: Becton, Dickinson and Company
ClinicalTrials.gov Identifier: NCT01645696     History of Changes
Other Study ID Numbers: BDT-11-CGM002
Study First Received: July 13, 2012
Last Updated: April 19, 2013
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014