Study of a Non-invasive Glucose Measuring Device

August 10, 2023 updated by: RSP Systems A/S

An Explorative, Non-randomized, Open-label, In-clinic Study, Investigating the Performance of a Novel Non-invasive Glucose Monitoring Device Using a New Guided Calibration Model

This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subject ≥18 years.
  2. Subject with type 2 diabetes.
  3. Signed informed consent form (ICF).

Exclusion Criteria:

  1. Individual treated with intensified insulin treatment.
  2. Sodium, Potassium. Creatinine, eGFR, and ALAT (more than three times the upper limit of normal range).
  3. Clinically relevant anaemia or thrombocytopenia.
  4. Infection with hepatitis B, C or HIV (if subject participates in subprotocol 1).
  5. Intake of anticoagulant medication (with the exception of acetylsalicylic acid, ASS 100).
  6. For female subjects: Pregnancy or breastfeeding or lack of a negative pregnancy test (except in case of menopause, sterilization, or hysterectomy).
  7. Subjects not able to understand and read local language.
  8. Cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the clinical investigation plan (CIP).
  9. Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease).
  10. Skin changes, tattoos, or diseases on right thenar (measurement site).
  11. Reduced circulation in right hand evaluated by Allen's test.
  12. Known allergy to medical grade alcohol.
  13. Haemodialysis.
  14. Topical administration of glucocorticoids at the right hand for the past 7 days or during the study period.
  15. Any disorder, which in the investigator's opinion, might jeopardise subject's safety or compliance with the CIP.
  16. Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental, or visual incapacity, language barriers, alcohol or drug abuse.
  17. Dependency from the sponsor or the clinical investigator (e.g., co-workers of the sponsor, the study site, and/ or their families).
  18. Subjects currently participating in another study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RSP-26-01
Device: Prototype 0.5
Investigational Medical Device collecting Raman data from tissue
Experimental: RSP-26-02
Device: Prototype 0.5
Investigational Medical Device collecting Raman data from tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance
Time Frame: 2 days
Repeated measurements of blood sugar, to cover the diurnal variation, with the non-invasive examination device, and compare the result with blood drawn capillary and venous
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 4 days
Frequency of adverse reactions related and non-related to the investigational device
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RSP Systems A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2023

Primary Completion (Actual)

July 27, 2023

Study Completion (Actual)

July 27, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RSP-26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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