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A Clinical Study of the Performance of a Glucose Blinding Protein-Based Continuous Glucose Monitor (GBP CGM)

NCT01469715 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-07-31

Study results available
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Summary

The purpose of this study is to assess the accuracy of the Becton Dickenson (BD) Technologies Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) in patients with Type 1 diabetes during low (goal glucose 55 mg/dL), normal (80-140 mg/dL) and high (\>180mg/dL) glucose levels over a 24 hour period. This will be achieved by monitoring blood sugar levels when a regular dinner meal is given, when a liquid breakfast meal (BOOST Original containing 41 grams Carbohydrates (CHO), 4 grams fat, 10 grams protein) is given, when subcutaneous insulin is dosed to induce hypoglycemia to a goal of 55 mg/dL, and when a regular lunch meal is given. A Continuous Glucose Monitor (CGM) is an electronic device that measures and displays blood sugar (glucose) levels in the body throughout the day and night. The method being used to detect blood sugar in the investigational Glucose Binding Protein-Based Continuous Glucose Monitor (GBP CGM) is different than the method that is currently in use by commercially available models.

Some sensors cannot tell the difference between glucose (sugar) and other substances such as Tylenol, aspirin or citric acid etc. Because they cannot tell the difference, they may give false readings. The GBP CGM is made to only recognize glucose in the body rather than other substances (e.g., Tylenol, aspirin, citric acid, etc.). As a result, the investigators expect the new GBP CGM to be more accurate at detecting low blood sugar levels than the current devices.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

GBP CGM

Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active \& one mock device simultaneously during hyperglycemic \& hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 \& 4: Subjects will return to the research center approximately 24 \& 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 \& 5.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Becton, Dickinson and Company

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Stacey Anderson, MD · University of Virginia, Center for Diabetes Technology

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01469715 on ClinicalTrials.gov