Trial record 8 of 1551 for:    diabetes research institute

Performance Evaluation of a Non-Invasive Glucose Monitor as Compared to CGM Data Acquired by the iPro2

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Sansum Diabetes Research Institute
Sponsor:
Information provided by (Responsible Party):
Howard Zisser, Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier:
NCT01831752
First received: March 5, 2013
Last updated: July 22, 2013
Last verified: July 2013
  Purpose

This study is for adults and adolescents with type 1 diabetes. The purpose of this study is to learn more about an investigational system to measure blood glucose. This system does not require blood to be drawn from the body, and it does not require a glucose sensor to be worn under the skin (subcutaneously). This device instead estimates blood glucose levels by shining infrared light on the skin and then using sophisticated statistical analysis on how the light bounces back or gets absorbed (spectral data). The researchers in this study will compare the accuracy of the new device to glucose measurement devices that are already approved by the FDA, including glucose meters and subcutaneous continuous glucose monitoring (CGM) sensors. Information learned from this study will be used in the development of tools for managing diabetes.


Condition
Type 1 Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Performance Evaluation of a Non-Invasive Glucose Monitor (Spectral Data Acquisition) as Compared to CGM Data Acquired by the iPro2

Resource links provided by NLM:


Further study details as provided by Sansum Diabetes Research Institute:

Primary Outcome Measures:
  • blood glucose correlation coefficient [ Time Frame: Up to 16 weeks ] [ Designated as safety issue: No ]
    To generate a non-invasive blood glucose measurement with continuous glucose monitor data and alternate site data.


Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Type 1 Diabetes Melitus
Subjects aged 12 through 75, previously diagnosed with type 1 diabetes mellitus, currently using insulin to treat their diabetes.

Detailed Description:

The purpose of the study is to evaluate the utility of a novel approach to non-invasive glucose sensing. The testing for each patient includes fingerstick and alternate site capillary blood measurements taken nearly simultaneously with a series of near-infrared spectra collected via a novel, proprietary fiber-optic probe. Simultaneously, subjects will be wearing a commercial continuous glucose measuring system (Medtronic iPro 2). The spectral data are converted to a prediction of tissue glucose using a proprietary pre-defined universal algorithm. Subjects are tested every 20 minutes for up to 12 hours per day and up to 6 visits per patient over a period of up to 4 months.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects aged 12 through 75, previously diagnosed with type 1 diabetes mellitus, currently using insulin to treat their diabetes.

Criteria

Inclusion Criteria:

  • Are between the ages of 12-75 years
  • Have been diagnosed with type 1 diabetes mellitus
  • Use insulin to treat your diabetes
  • Agree and are able to follow the study plans as described in this informed consent form.

Exclusion Criteria:

  • Are a pregnant woman or nursing mother
  • Have skin conditions that could cause a problem wearing a glucose sensor on your abdomen (stomach area) and/or having spectral data measured from your forearm with the non-invasive device.
  • Are currently taking part in another clinical study
  • Have taken part in this study before
  • Have experienced severe hypoglycemia (an episode of low blood sugar that you were unable to treat yourself - e.g., seizure, coma, unconsciousness) any time within the past six months
  • Have any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent you from completing the study
  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: NCT01831752

Contacts
Contact: Howard Zisser, MD 805-682-7640 ext 255 hzisser@sansum.org

Locations
United States, California
Sansum Diabetes Research Institute Recruiting
Santa Barbara, California, United States, 93105
Contact: Lane    805-682-7640 ext 235      
Principal Investigator: Howard Zisser, M.D.         
Sponsors and Collaborators
Sansum Diabetes Research Institute
Investigators
Principal Investigator: Howard Zisser, MD Sansum Diabetes Research Institute
  More Information

No publications provided

Responsible Party: Howard Zisser, Director of Clinical Research and Technology, Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT01831752     History of Changes
Other Study ID Numbers: ZY001
Study First Received: March 5, 2013
Last Updated: July 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Sansum Diabetes Research Institute:
Diabetes
Type 1
Continuous glucose monitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014