NCT04518813

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 24, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2022

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

August 13, 2020

Last Update Submit

November 17, 2023

Conditions

Diabetes Mellitus

Keywords

Non-invasive glucose monitoringRaman spectroscopy

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 years

  • 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

    2 years

Secondary Outcomes (1)

  • Device function

    2 years

Study Arms (1)

RSP-24

EXPERIMENTAL

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

Device: Prototype 0.5

Interventions

Prototype 0.5DEVICE

Investigational Medical Device collecting Raman data from tissue

RSP-24

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 19, 2020

Study Start

September 24, 2020

Primary Completion

April 23, 2022

Study Completion

April 23, 2022

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

DE(1)