- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01645696
Three-day, In-clinic Evaluation of the BD 2nd Generation Continuous Glucose Sensor Device in Type 1 Diabetics
December 17, 2021 updated by: Becton, Dickinson and Company
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M4G 3E8
- >LMC Endocrinology Centre, Clinical Research Unit
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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%
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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
|
continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.
|
Active Comparator: Medtronic iPro 2 Professional CGM
Commercial glucose oxidase continuous glucose monitor
|
continuous subcutaneous glucose monitoring for 72 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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72 hours
|
Number of participants with adverse events
Time Frame: up to 89 days or until the subject is discharged
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At each study contact, subjects will be questioned about any adverse events that may have occurred and are potentially related to the device.
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up to 89 days or until the subject is discharged
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Up to 36 days
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Skin thickness using ultrasound
Time Frame: Upon removal of the devices
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Skin thickness will be measured at the sensor sites and a control site (on the abdomen) immediately after removal of the device.
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Upon removal of the devices
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Insulin levels
Time Frame: 72 hours
|
Blood samples will be taken at pre-determined times following insulin dosings to test for insulin levels:
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72 hours
|
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.
|
36 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ronnie Aronson, MD, LMC Endocrinology Centre, Clinical Research Unit
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
July 13, 2012
First Submitted That Met QC Criteria
July 18, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Actual)
December 29, 2021
Last Update Submitted That Met QC Criteria
December 17, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BDT-11-CGM002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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