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OpenTrials
Completed

NCT Number: NCT05851469

Study of a Non-invasive Glucose Measuring Device

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ulm, 89081, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Prototype 0.5

Device

Investigational Medical Device collecting Raman data from tissue

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse events

    Time frame: 4 days

    Frequency of adverse reactions related and non-related to the investigational device

Sponsors and collaborators

Lead sponsor

RSP Systems A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 9, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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