Performance and Safety Evaluation of a Novel Non-invasive Glucose Monitoring Device and Evaluation of the Instructions for Use

NCT04033042 | Completed

• 1 other identifier: RSP-21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to demonstrate the safety and performance of a novel non-invasive glucose monitoring device, to collect data and reference measurements for establishment of calibration models and to evaluate the instructions for use for the device. This study will be an explorative study with 10 study subjects.

Conditions

Diabetes Mellitus

Keywords

Non-invasive glucose monitoring; Raman spectroscopy

Outcome Measures

Primary Outcomes (2)

• Measurement accuracy

  Accuracy of measurements performed on the IMD will be evaluated by data from subjects. Data will be analyzed by Mean Absolute Relative Difference (MARD).

  4 months

• Risk/benefit analysis

  Risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects and the clinical performance safety profile.

  4 months

Secondary Outcomes (3)

• Review of IFU based on clinical performance.

  4 months

• Review of IFU based on number of safety events.

  4 months

• Number of encountered Device Deficiencies

  4 months

Study Arms (2)

Protocol 1

EXPERIMENTAL

RSP-21 Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 41 days.

Device: Prototype 0.5

Protocol 2

EXPERIMENTAL

RSP-21 Subjects will perform daily measurements on the IMD (Prototype 0.5) in addition to capillary reference measurements for 41 days. One group of subjects will receive training in the use of the device the other will not. Both groups will receive the instructions for use.

Device: Prototype 0.5

Interventions

Prototype 0.5 DEVICE

Subjects will perform daily measurements on the IMD (Prototype 0.5) for 41 days.

Protocol 1; Protocol 2

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects ≥18 years of age
• Individuals diagnosed with type 1 diabetes. Gestational diabetes excluded
• Skin phototype 1-4
• Willing to perform up to 12 finger sticks during each day of out-patient measurements and up to 40 finger sticks at the two in-clinic study days
• Wireless internet connection at home to be used in the study

You may not qualify if:

• For female subjects: Pregnancy or subject is attempting to conceive or not willing and able to practice NCA approved birth control during the study duration
• For female subjects: breastfeeding
• Subjects currently participating in another study
• Subjects not able to understand and read German
• 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 hand thenar (sensor application site)
• 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
• Medical history or any condition that may, in the opinion of the investigator compromise the subject's ability to participate
• Comorbidity or concomitant medical condition which, in the opinion of the Investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff
• 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)
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment

Sponsors & Collaborators

• RSP Systems A/S: lead
• Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm: collaborator

Study Sites (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungs-gesellschaft mbH an der Universität Ulm (IDT)

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Guido Freckman

  IfDT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: One group will receive the instructions for use and the other will not.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 25, 2019
• Study Start: September 18, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)