A Comparison Study of Prototype Continuous Glucose Sensors in the Intradermal and Subcutaneous Spaces

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: NCT01093833
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : May 6, 2016
Information provided by (Responsible Party):
Becton, Dickinson and Company

Brief Summary:
The purpose of this study is to compare two continuous glucose sensors, one placed subcutaneous (under the skin) and one placed intradermal (in the skin) over 12-14 hours.

Condition or disease Intervention/treatment Phase
Diabetes Device: BD Continuous glucose monitor (BD CGM) Device: YSI Glucose Analyzer Device: Medtronic Guardian CGM Phase 1

Detailed Description:

This was a single site, non-randomized study. The study consisted of a screening visit (Visit 1), during which the subject was consented and the inclusion and exclusion criteria confirmed, an experimental intervention (Visit 2) and a follow-up visit (Visit 3). The experimental intervention was based on an initial glucose clamp involving a basal intravenous (IV) insulin infusion and IV insulin boluses plus IV glucose infusion / IV glucose boluses as required to maintain euglycemic, hypoglycemic and hyperglycemic plateaus respectively in 41 subjects with Type 1 or Type 2 Diabetes. At the end of hour five of the study the glucose clamp was discontinued and subjects given a standardized meal to stimulate a hyperglycemic excursion

Each subject participated in one experimental intervention. During the glucose clamp intervention, the subject's blood glucose was continuously monitored either by means of the Biostator or by frequent venous blood glucose measurements based on a standard lab method (YSI STAT2300 analyzer), and measured by means of the BD Technologies test devices, and the Medtronic Guardian CGM. Once the clamp was discontinued the Biostator was discontinued as well. During the unclamped period and meal the subjects BG was monitored via the YSI Glucose Analyzer, the BD CGM sensor and the Medtronic Guardian CGM.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Comparison Study of Prototype Continuous Glucose Sensors in the Intradermal and Subcutaneous Spaces
Study Start Date : January 2009
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Continuous Glucose Monitoring
Each subject will participate in one experimental intervention. Blood glucose will be measured with the BD continuous glucose monitor (BD CGM), with the Medtronic Guardian CGM and the YSI Glucose Analyzer as controls for 12-14 hours.
Device: BD Continuous glucose monitor (BD CGM)
Continuous glucose monitoring for 12-14 hours
Other Name: MiniMed Guardian CGM
Device: YSI Glucose Analyzer
Continuous glucose monitoring for 12-14 hours
Device: Medtronic Guardian CGM
Continuous glucose monitoring for 12-14 hours

Primary Outcome Measures :
  1. Blood Glucose [ Time Frame: 12-14 hours ]

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:

  • Otherwise healthy male and female subjects with Type 1 or Type 2 diabetes mellitus
  • Signed informed consent
  • Age between 18 and 65 years, inclusive
  • Body mass index between 19 and 30 kg/m², inclusive
  • HbA1c < 11 %

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 (ALT) or aspartate aminotransferase (AST) ≥ three times the upper reference limit
  • Impaired renal function measured as creatinine > 1.2 times above the upper limit of normal.
  • Severe acute diseases, i.e. cardiac, pulmonary, gastrointestinal, hepatic, neurologic, or infectious that might interfere with the performance of this study, as judged by the Investigator.
  • Severe chronic diseases, as judged by the investigator other than Type 1 Diabetes
  • Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
  • Known microvascular (diabetic) complications (other than diabetic non-proliferative retinopathy), such as e.g. history of laser coagulation, proliferative diabetic retinopathy, known diabetic nephropathy or neuropathy requiring treatment
  • Positive serology for Hepatitis B, Hepatitis C or HIV
  • Pregnancy, breast-feeding or intention of becoming pregnant or not using adequate contraceptive measures.
  • Known current or recent alcohol or drug abuse
  • Blood donation of more than 500 ml within the last three months
  • Anticoagulant therapy
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
  • Previous participation in a study involving the GBP-based sensor
  • Has taken more than 4000 mg or more of acetaminophen within the past 24 hours (i.e. 13 or more regular strength or 8 or more extra strength Tylenol in the past 24 hours)
  • Any skin condition that may be judged to have affect on study ( e.g., bad sunburn, pre-existing dermatitis)

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): NCT01093833

United States, California
Profil Institute for Clinical Research Inc
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Becton, Dickinson and Company
Principal Investigator: Morrow Linda, MD Profil Insitute for Clinical Research

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Becton, Dickinson and Company Identifier: NCT01093833     History of Changes
Other Study ID Numbers: BDT-08-CGM-02
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: May 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Becton, Dickinson and Company:
Type 1 diabetes
Type 2 diabetes
Diabetes mellitus
Blood glucose
Continuous blood glucose monitoring