CClinicalTrials.gg
Sign In
CompletedNCT04518813Updated Nov 18, 2023

A Study of a Non-invasive Glucose Measuring Device in Out-patient Settings

An interventional study of Prototype 0.5 in Diabetes Mellitus, sponsored by RSP Systems A/S. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.

Sponsored by RSP Systems A/S · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
173
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes Mellitus

Keywords

  • Non-invasive glucose monitoring
  • Raman spectroscopy
03

In context

Lead sponsor

RSP Systems A/S is the lead sponsor of 14 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female subjects minimum 18 years of age
  • Individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year
  • Willing to perform up to 12 finger-pricks during each day of out-patient measurements
  • Signed informed consent
  • For women of childbearing potential: Willing and able to practice FDA approved birth control during the duration of the investigation
  • Subject has a 2.4 GHz wireless internet connection at home (standard in normal routers) to be used in the study

Exclusion criteria

Exclusion Criteria:

  • For female subjects: Pregnancy or breastfeeding
  • Skin phototype VI categorized by Fitzpatrick scale measured on thenar
  • 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 protocol
  • Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease)
  • Extensive 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
  • Hemodialysis
  • Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected
  • Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol
  • Severe diabetes-related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s)
  • 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
  • Subjects who have participated in the study IDT-1904-RO/RSP-21 or RSP-19.
  • Incapacity for consent
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
173 participants (actual)

Study arms

  • Experimental
    RSP-24

    Subjects will perform calibrations on the IMD (Prototype 0.5) for 41 days over a 60 day period.

    Device: Prototype 0.5

Interventions

  • DevicePrototype 0.5

    Investigational Medical Device collecting Raman data from tissue

06

What researchers measure

Primary outcomes

  1. Determination of number of calibration days

    The number of calibration days needed for reaching a well-performing glucose predictive calibration model will be determined. The clinical performance of the reduced calibration model will be based on the data from the validation part by studying linear regression, Inter Subject Unified Performance value and Consensus Error Grid.

    Time frame: 2 years

  2. Safety evaluation of the Investigational Medical Device by reporting of adverse events

    Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical investigation

    Time frame: 2 years

Secondary outcomes

  1. Device function

    Device function will be evaluated in regard to durability and reliability. This is evaluated by reported device deficiencies during the study in the terms of subject diaries

    Time frame: 2 years

07

Study locations

1 site
  • Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
    Ulm, 89081, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04518813
Lead sponsor
RSP Systems A/S
Responsible party
Sponsor
First posted
Aug 19, 2020
Start date
Sep 24, 2020
Primary completion
Apr 23, 2022
Completion
Apr 23, 2022
Last update
Nov 18, 2023

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 Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

RSP Systems A/S

Start the discussion