Non-invasive Glucose Measurement Using Laser Technology

NCT03276949 | Completed

• 1 other identifier: 2002948
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to evaluate the capability of Raman spectroscopy as a non-invasive method for monitoring concentrations of glucose by illuminating a small spot on the skin, collecting and analyzing the return light. The glucose measurements obtained by Raman Spectroscopy are correlated with those obtained using YSI glucose analyzer and ACCUCHECK instruments.

Conditions

Oral Glucose Tolerance Test

Keywords

Blood glucose; non-invasive; Raman spectroscopy

Outcome Measures

Primary Outcomes (1)

• Non-Invasive Random Glucose Measurement using Raman Spectroscopy during Oral Glucose Tolerance Test

  Blood glucose measurement using Raman spectroscopy

  Two weeks

Secondary Outcomes (1)

• Non-Invasive Random Glucose Measurement using Raman Spectroscopy

  Two weeks

Study Arms (1)

Healthy volunteers

Non-diabetic healthy men/women in between age group 18-80 years (all races and ethnicity) will be included for blood glucose measurements

Device: Blood glucose measurement

Interventions

Blood glucose measurement DEVICE

Device used to measure blood glucose levels

Also known as: Raman Spectroscopy BLOOD GLUCOSE LEVEL MEASUREMENT

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All races and ethnicity

You may qualify if:

• wenty healthy men and women will be studied who will be
• Non diabetic
• Age group between 18 - 80 years
• Prior fasting blood glucose (FBG) values less than or equal to 125 mg/dL
• All races and ethnicity
• Smokers and nonsmokers

You may not qualify if:

• Subjects with a known diabetic condition
• With FBG greater than 125 mg/dl or random blood sugar above 200 mg/dL since the study requires observing normal glucose level changes during oral glucose tolerance test.
• Subjects with prior indication of skin irritation or with visible skin rashes
• Any phobia for mechanical device or needle
• Pregnant women will be excluded from the study due to the required blood drawing.
• Children will be excluded as they may not tolerate IV line placement or comply with finger-pricking
• Subjects should not have given blood prior to 8 weeks of the study

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Massachusetts Institute of Technology: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

Study Officials

• Uzma Khan, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

• Anandhi Upendran

  University of Missouri-Columbia

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: September 8, 2017
• Study Start: April 22, 2016
• Primary Completion: April 29, 2016
• Study Completion: March 13, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: One year after publication