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

May 4, 2016 updated by: Becton, Dickinson and Company
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

40

Phase

  • Phase 1

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

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Profil Institute for Clinical Research Inc

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:

  • 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)

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: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood Glucose
Time Frame: 12-14 hours
12-14 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Becton, Dickinson and Company

Investigators

  • Principal Investigator: Morrow Linda, MD, Profil Insitute for Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (ACTUAL)

April 1, 2009

Study Completion (ACTUAL)

April 1, 2009

Study Registration Dates

First Submitted

March 25, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (ESTIMATE)

March 26, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BDT-08-CGM-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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