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CompletedNCT06862778Updated Apr 28, 2026

Clinical Diagnosis of Diabetes Using Surface-enhanced Raman Spectroscopy Liquid Biopsy and Machine Learning

An interventional study of SERS in Diabetes, sponsored by University Hospital, Aachen. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.

Sponsored by University Hospital, Aachen · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Feb 2024, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This project aims to adapt the gold nanoparticle-based surface-enhanced Raman spectroscopy (SERS) technology to clinical application. In this exploratory study, a measurement protocol will be established to investigate whether SERS (combined with multivariate data analysis or machine learning algorithms) allows the diagnosis of patients with diabetes.

Read the detailed description

This study on the clinical application of surface-enhanced Raman spectroscopy (SERS) comprises two parts. First, a SERS measurement protocol will be developed to enhance the interactions between gold nanoparticles and the components of the patient's samples, maximizing Raman spectroscopical signatures. Given the complex composition of human blood, which encompasses numerous biological constituents, the study focuses on serum, a component obtained through centrifugation after removing cells and clotting factors. Fifteen spectra will be recorded per sample. The raw spectra will be post-processed, including removal of the substrate signal, baseline correction, vector normalization, and smoothing steps.

The SERS measurement protocol established in the first section will subsequently be applied to samples of healthy and diabetes patients. Two different approaches will be followed. First, multivariate data analysis will be performed to identify distinctive feature characteristics in the samples that correlate to their group (healthy and diabetes patients), allowing patient diagnosis. Second, different machine learning algorithms and data augmentation strategies will be explored for better patient diagnosis.

02

Conditions studied

  • Diabetes

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Keywords

  • Diabetes
  • Sensing
  • SERS
  • Gold nanoparticles
  • Diagnositcs
  • Surface-enhanced Raman Spectroscopy
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 52 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University Hospital, Aachen is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient at Nishtar Medical University
  • Patient age from 18 to 70 years
  • Confirmed disease (for diabetic group)

Exclusion criteria

Exclusion Criteria:

  • Patients with severe concurrent diseases
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Healthy

    The Raman spectra of healthy patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

    Diagnostic Test: SERS

  • Experimental
    Diabetes

    The Raman spectra of diabetic patient samples will be measured in the presence of gold nanoparticles, which will enhance the spectroscopic characteristics of serum components via near-field enhancements.

    Diagnostic Test: SERS

Interventions

  • Diagnostic testSERS

    Spectroscopic assessment of serum samples from healthy and diabetic patients to identify characteristics for diagnosis.

    Also known as: Surface-enhanced Raman Spectroscopy

06

What researchers measure

Primary outcomes

  1. SERS measurements to differentiate between healthy and diabetic patients

    SERS assessment of healthy and diabetic patient samples to identify unique spectroscopical characteristics to discriminate between healthy and diabetic patients

    Time frame: Through study competition, up to 1 year

07

Study locations

1 site
  • RWTH Aachen university hospital
    Aachen, 52074, Germany
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2024 to primary completion in Aug 2024, 6 months.

Of 1,583 non-industry interventional studies with no phase under Diabetes Mellitus, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 6 months is below that.

Counting every sponsor, half of 1,743 studies reached it within 21 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2025
First posted
Mar 6, 2025
StartActual
Feb 2, 2024
Primary completionActual
Aug 31, 2024
CompletionActual
Jul 31, 2025
Last update
Apr 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06862778
Lead sponsor
University Hospital, Aachen
Collaborators
University of Agriculture Faisalabad, Nishtar Medical University
Responsible party
Roger Molto Pallares (Group Leader, University Hospital, Aachen) — Principal investigator
First posted
Mar 6, 2025
Start date
Feb 2, 2024
Primary completion
Aug 31, 2024
Completion
Jul 31, 2025
Last update
Apr 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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