Oral Glucose Tolerance Test(Raman)NCT03276949
Non-invasive Glucose Measurement Using Laser Technology
An observational study of Oral Glucose Tolerance Test, run by University of Missouri-Columbia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Glucose Tolerance Test
- What is being tested?
- Blood glucose measurement
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 22 Apr 2016to 13 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All races and ethnicity
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Non-Invasive Glucose Measurement Using Raman Spectroscopy During Oral Glucose Tolerance Test
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.
Read the 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.
- Conditions
- Oral Glucose Tolerance Test
- Being tested
- Blood glucose measurement
- Keywords
- Blood glucose, non-invasive, Raman spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose measurementDevice
Also called Raman Spectroscopy BLOOD GLUCOSE LEVEL MEASUREMENT
Device used to measure blood glucose levels
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Blood glucose measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-Invasive Random Glucose Measurement using Raman Spectroscopy during Oral Glucose Tolerance Test
Blood glucose measurement using Raman spectroscopy
Measured: Two weeks
Secondary outcomes (1)
Non-Invasive Random Glucose Measurement using Raman Spectroscopy
Correlation with Serum and capillary blood glucose measurement
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start22 Apr 2016
- Primary completion29 Apr 2016
- Study completion13 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Glucose Tolerance TestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Uzma Z Khan, University of Missouri-Columbia
- Investigators
- Uzma Khan, MD, Principal investigator, University of Missouri-ColumbiaAnandhi Upendran, Study director, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276949
- Sponsor's protocol ID
- 2002948
- Acronym
- (Raman)
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with MIT for analysis
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Glucose Measurement Using Raman Spectroscopy During Oral Glucose Tolerance Test
- ClinicalTrials.gov ID
- NCT03276949
- Acronym / sponsor ID
- (Raman) / 2002948
- Conditions
- Oral Glucose Tolerance Test
- Keywords
- Blood glucose, non-invasive, Raman spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 29 Apr 2016 (actual)
- Study completion
- 13 Mar 2017 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Blood glucose measurementNon-diabetic healthy men/women in between age group 18-80 years (all races and ethnicity) will be included for blood glucose measurements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All races and ethnicity
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood glucose measurementAlso: Raman Spectroscopy BLOOD GLUCOSE LEVEL MEASUREMENTDevice used to measure blood glucose levels | Device | Healthy volunteers |
Primary outcome
Non-Invasive Random Glucose Measurement using Raman Spectroscopy during Oral Glucose Tolerance Test
Time frame: Two weeks
Blood glucose measurement using Raman spectroscopy
1 secondary outcome
Non-Invasive Random Glucose Measurement using Raman Spectroscopy
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2017.
- Individual participant dataSharing planned: Yes. Data will be shared with MIT for analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uzma Khan, MD principal investigator
University of Missouri-Columbia
Anandhi Upendran study director
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Glucose Tolerance Test, run by University of Missouri-Columbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-Invasive Random Glucose Measurement using Raman Spectroscopy during Oral Glucose Tolerance Test (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2017.