Non-invasive Glucose Measurement Using Laser Technology

Completed

• Conditions: Oral Glucose Tolerance Test
• Interventions: Device: Blood glucose measurement

• Registration Number: NCT03276949
• Lead Sponsor: University of Missouri-Columbia

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.

Detailed Description

Diabetes mellitus (DM), caused by impairment in the glucose metabolism is a worldwide epidemic. It is projected that by the year 2035 there will be approximately 592 million diabetic patients. Blood glucose (BG) levels are finely regulated by insulin secretion and any defects in the secretion or function can lead to DM. As no well-established medical intervention for DM has been known till date, continuous monitoring of BG is the only way to avoid secondary metabolic complications such as strokes, heart attacks, high blood pressure, blindness and coma. Diagnosis and therapeutic monitoring of diabetes requires direct measurement of plasma (or blood) glucose. Measurement of the fasting glucose level is the preferred test for diagnosis of diabetes in children and non-pregnant adults, while the oral glucose tolerance test (OGTT) is the preferred method of diagnosis for gestational diabetes. In addition, patients with an established diagnosis of insulin-dependent diabetes (all type-I and many type-II) require frequent glucose measurements for therapeutic monitoring. Emergence of hand-held glucose sensors have enabled patients with the ability to self-monitor the BG level. The frequent monitoring requires small blood sample (\<1 µL) obtained by a "finger-pricking" and electrochemical sensing using a portable 'glucometer'. However the procedure is inconvenient, results in poor patient compliance and lacks in providing real time information about concentration changes. Regardless of the clinical test performed, withdrawal of blood or interstitial fluid is currently required for measurement of BG levels.

The proposed study is based on preliminary research supported by the MIT Laser Biomedical Research Center (LBRC), and promising results obtained with spectroscopic measurement of blood glucose in the laboratory, in an experimental animal model, and in a small cohort of human subject volunteers. In order to make non-invasive glucose measurement a viable clinical technology, however, a methodological implementation and validation from bench to bedside is required. In the application, we propose to accomplish this goal by means of a carefully-designed translational research study employing specifically-designed instrumentation and methods for pre-clinical validation and early clinical studies in human subjects. These studies will incrementally increase in data complexity, culminating in a clinical study in human subjects, as well as a non-invasive, spectroscopic glucose tolerance test as an alternative to OGTT.

Study Timeline

• Study Start: 2016-04-22
• Primary Completion: 2016-04-29
• Study Completion: 2017-03-13
• Status Verified: 2017-09
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-07
• Last Update Submitted: 2017-09-07
• Study First Posted: 2017-09-08
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Blood glucose measurement	Non-diabetic healthy men/women in between age group 18-80 years (all races and ethnicity) will be included for blood glucose measurements

Primary Outcome Measures

Name	Time	Method
Non-Invasive Random Glucose Measurement using Raman Spectroscopy during Oral Glucose Tolerance Test	Two weeks	Blood glucose measurement using Raman spectroscopy

Secondary Outcome Measures

Name	Time	Method
Non-Invasive Random Glucose Measurement using Raman Spectroscopy	Two weeks	Correlation with Serum and capillary blood glucose measurement