MedDataX Logo

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

NCT ID: NCT01831752

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Type 1 Diabetes Melitus

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sansum Diabetes Research Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kristin Castorino, DO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Howard Zisser, MD

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZY001

Identifier Type: -

Identifier Source: org_study_id