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

This study has been completed.
Sponsor:
Information provided by:
Becton, Dickinson and Company
ClinicalTrials.gov Identifier:
NCT01093833
First received: March 25, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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 Intervention Phase
Diabetes
Device: MiniMed Guardian CGM (BD CGM)
Device: YSI Glucose Analyzer
Device: Medtronic Guardian CGM
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Comparison Study of Prototype Continuous Glucose Sensors in the Intradermal and Subcutaneous Spaces

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Blood Glucose [ Time Frame: 12-14 hours ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CGM
Each subject will participate in one experimental intervention. Blood glucose will be measured by the BD-Continuous Glucose Monitor (CGM), with the Medtronic CGM and the YSI Glucose analyser as controls for 12-14 hours.
Device: MiniMed Guardian CGM (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

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.

  Eligibility

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

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)
  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: NCT01093833

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

No publications provided by Becton, Dickinson and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Judge, MD, VP Corporate Clinical Development, Becton Dickinson
ClinicalTrials.gov Identifier: NCT01093833     History of Changes
Other Study ID Numbers: BDT-08-CGM-02
Study First Received: March 25, 2010
Last Updated: March 25, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014