NCT01093833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
Last Updated

May 6, 2016

Status Verified

May 1, 2016

Enrollment Period

3 months

First QC Date

March 25, 2010

Last Update Submit

May 4, 2016

Conditions

Diabetes

Keywords

DiabetesType 1 diabetesType 2 diabetesDiabetes mellitusBlood glucoseContinuous blood glucose monitoringCGM

Outcome Measures

Primary Outcomes (1)

  • Blood Glucose

    12-14 hours

Study Arms (1)

Continuous Glucose Monitoring

EXPERIMENTAL

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)Device: YSI Glucose AnalyzerDevice: Medtronic Guardian CGM

Interventions

BD Continuous glucose monitor (BD CGM)DEVICE

Continuous glucose monitoring for 12-14 hours

Also known as: MiniMed Guardian CGM
Continuous Glucose Monitoring
YSI Glucose AnalyzerDEVICE

Continuous glucose monitoring for 12-14 hours

Continuous Glucose Monitoring
Medtronic Guardian CGMDEVICE

Continuous glucose monitoring for 12-14 hours

Continuous Glucose Monitoring

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 %

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institute for Clinical Research Inc

Chula Vista, California, 91911, United States

Location

Related Publications (1)

  • Judge K, Morrow L, Lastovich AG, Kurisko D, Keith SC, Hartsell J, Roberts B, McVey E, Weidemaier K, Win K, Hompesch M. Continuous glucose monitoring using a novel glucose/galactose binding protein: results of a 12-hour feasibility study with the becton dickinson glucose/galactose binding protein sensor. Diabetes Technol Ther. 2011 Mar;13(3):309-17. doi: 10.1089/dia.2010.0130. Epub 2011 Feb 7.

    PMID: 21299393DERIVED

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Morrow Linda, MD

    Profil Insitute for Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 26, 2010

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 6, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)