DiabetesRaman GlucoseNCT07311421
Raman Spectroscopy-Based Non-Invasive Blood Glucose Detection
An observational study of Diabetes, run by Beijing Shijitan Hospital, Capital Medical University at 2 sites in China.
Trial summary
Diabetes is a chronic metabolic disease that is widely prevalent globally, with its incidence rate continuously increasing, posing significant challenges to patient health and public health systems. In China, the number of diabetes patients ranks first in the world, with an adult prevalence rate as high as 12.8%. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Raman spectroscopy for blood glucose measurement
- How many people
- 49 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2026to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals aged 18-75 years, either healthy or with diabetes, including both males and females, who have signed the informed consent form. There are no requirements regarding race, education level, or economic status.
Who may be able to join
- Age range: 18-75 years old. Gender: unlimited. Health status: patients with diagnosed diabetes or healthy volunteers. Nail health status: no obvious infection, discoloration, peeling and other lesions of the nail, so as to ensure the accuracy of Raman spectroscopy measurement.
- Willing to participate in the study and sign the informed consent.
Who cannot join
- Nail diseases: such as fungal infections, psoriasis, trauma resulting in nail damage or deformity.
- The presence of factors that influenced the measurement results: Participants who used nail polish, fake nails, or nail products. Recent use of drugs containing heavy metals (which may affect nail composition) and skin conditions are not appropriate for such tests.
- Pregnant or lactating women. People with serious chronic diseases (such as terminal cancer, end-stage renal disease) or mental illness.
- Non-cooperation or inability to complete the entire research process, such as refusal or inability to complete Raman spectrum acquisition.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100080
Yuanyuan Miao, +86 18815015576, miaoyuanyuan1001@163.com
- Recruiting
Beijing Shijitan Hospital
Haidian, Beijing Municipality, 100080
Yuanyuan Miao, +86 18815015576, miaoyuanyuan1001@163.com
About this study
Official title: Clinical Study of Non-invasive Blood Glucose Detection Technology Based on Raman Spectroscopy
Diabetes is a chronic metabolic disease that is widely prevalent globally, with its incidence rate continuously increasing, posing significant challenges to patient health and public health systems. In China, the number of diabetes patients ranks first in the world, with an adult prevalence rate as high as 12.8%. The core of diabetes management is blood glucose control. However, traditional finger-prick blood testing methods are inconvenient and have low patient compliance. In recent years, non-invasive blood glucose detection technologies have become a research hotspot. Among them, optical methods, especially spectroscopy techniques, are considered to have the most application potential due to their non-invasive, convenient, and stable characteristics.
Raman spectroscopy, as an important branch of spectroscopy, has advantages such as non-invasiveness and high specificity, and has been successfully applied to blood glucose detection in laboratory settings. However, its clinical application is still in the exploratory stage. Foreign research has validated its feasibility, and domestic research has also made certain progress, but overall, it is still in its infancy. This study aims to compare the consistency and accuracy of Raman spectroscopy non-invasive blood glucose detection with traditional finger-prick blood glucose detection by comparing the blood glucose values measured by the two methods at the same time point. Additionally, the study will assess the participants' satisfaction and acceptance of the two methods through questionnaires. The results of this study will provide a scientific basis for the clinical application of Raman spectroscopy technology and offer references for the promotion of non-invasive blood glucose detection technologies. This will help advance the development of non-invasive blood glucose detection technologies and improve the treatment compliance and quality of life of diabetes patients.
- Conditions
- Diabetes
- Being tested
- Raman spectroscopy for blood glucose measurement
- Keywords
- Diabetes Management, Raman Spectroscopy, Non-invasive Blood Glucose Detection, Clinical Application
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raman spectroscopy for blood glucose measurementDiagnostic test
Raman spectroscopy non-invasive blood glucose measurement group
| Study group | Role | What they receive |
|---|---|---|
| Control group | Fingertip blood to measure blood sugar | |
| Raman spectroscopy non-invasive blood glucose measurement group | Blood glucose was measured using Raman spectroscopy noninvasive blood glucose measurement Receives: Diagnostic Test: Raman spectroscopy for blood glucose measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose value
Blood glucose value was assessed as a primary outcome measure in this study. It reflects the concentration of glucose in the blood and serves as a critical indicator for evaluating the metabolic status, particularly in the context of diabetes management.
Measured: At the single baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion10 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Institute of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311421
- Sponsor's protocol ID
- IIT2025-029-002
- Acronym
- Raman Glucose
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Non-invasive Blood Glucose Detection Technology Based on Raman Spectroscopy
- ClinicalTrials.gov ID
- NCT07311421
- Acronym / sponsor ID
- Raman Glucose / IIT2025-029-002
- Conditions
- Diabetes
- Keywords
- Diabetes Management, Raman Spectroscopy, Non-invasive Blood Glucose Detection, Clinical Application
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Beijing Shijitan Hospital, Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Institute of Technology
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 10 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 31 Dec 2025 (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.
Diabetes is a chronic metabolic disease that is widely prevalent globally, with its incidence rate continuously increasing, posing significant challenges to patient health and public health systems. In China, the number of diabetes patients ranks first in the world, with an adult prevalence rate as high as 12.8%. The core of diabetes management is blood glucose control. However, traditional finger-prick blood testing methods are inconvenient and have low patient compliance. In recent years, non-invasive blood glucose detection technologies have become a research hotspot. Among them, optical methods, especially spectroscopy techniques, are considered to have the most application potential due to their non-invasive, convenient, and stable characteristics.
Raman spectroscopy, as an important branch of spectroscopy, has advantages such as non-invasiveness and high specificity, and has been successfully applied to blood glucose detection in laboratory settings. However, its clinical application is still in the exploratory stage. Foreign research has validated its feasibility, and domestic research has also made certain progress, but overall, it is still in its infancy. This study aims to compare the consistency and accuracy of Raman spectroscopy non-invasive blood glucose detection with traditional finger-prick blood glucose detection by comparing the blood glucose values measured by the two methods at the same time point. Additionally, the study will assess the participants' satisfaction and acceptance of the two methods through questionnaires. The results of this study will provide a scientific basis for the clinical application of Raman spectroscopy technology and offer references for the promotion of non-invasive blood glucose detection technologies. This will help advance the development of non-invasive blood glucose detection technologies and improve the treatment compliance and quality of life of diabetes patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Fingertip blood to measure blood sugar |
| Raman spectroscopy non-invasive blood glucose measurement group | – | Diagnostic Test: Raman spectroscopy for blood glucose measurementBlood glucose was measured using Raman spectroscopy noninvasive blood glucose measurement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals aged 18-75 years, either healthy or with diabetes, including both males and females, who have signed the informed consent form. There are no requirements regarding race, education level, or economic status.
Key inclusion criteria (2 listed)
- Age range: 18-75 years old. Gender: unlimited. Health status: patients with diagnosed diabetes or healthy volunteers. Nail health status: no obvious infection, discoloration, peeling and other lesions of the nail, so as to ensure the accuracy of Raman spectroscopy measurement.
- Willing to participate in the study and sign the informed consent.
Key exclusion criteria (4 listed)
- Nail diseases: such as fungal infections, psoriasis, trauma resulting in nail damage or deformity.
- The presence of factors that influenced the measurement results: Participants who used nail polish, fake nails, or nail products. Recent use of drugs containing heavy metals (which may affect nail composition) and skin conditions are not appropriate for such tests.
- Pregnant or lactating women. People with serious chronic diseases (such as terminal cancer, end-stage renal disease) or mental illness.
- Non-cooperation or inability to complete the entire research process, such as refusal or inability to complete Raman spectrum acquisition.
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 |
|---|---|---|
| Raman spectroscopy for blood glucose measurementRaman spectroscopy non-invasive blood glucose measurement group | Diagnostic test | Raman spectroscopy non-invasive blood glucose measurement group |
Primary outcome
Blood glucose value
Time frame: At the single baseline
Blood glucose value was assessed as a primary outcome measure in this study. It reflects the concentration of glucose in the blood and serves as a critical indicator for evaluating the metabolic status, particularly in the context of diabetes management.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Beijing Shijitan Hospital, Capital Medical University at 2 sites in China.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Miao (+86 18815015576, miaoyuanyuan1001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose value (time frame: At the single baseline). 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 31 Dec 2025.