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Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03530644
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
RSP Systems A/S

Study Description
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Brief Summary:
This clinical study has been launched to compare the performances of two models of a non-invasive glucose monitoring device.

Condition or disease Intervention/treatment Phase
Type1diabetes Device: WM3.4NR Device: P0.1 Not Applicable

Detailed Description:

Subjects will be optical screened at baseline visit. Study comprises two in-clinic visits. Subjects will arrive in a fasting state and and oral glucose bolus will be administered.

Subjects will during each of two study days be subjected to optical readings on two different device prototypes. During each of the study days, FGM readings, capillary blood samples and arterialized venous blood samples will be collected.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device
Actual Study Start Date : August 28, 2018
Actual Primary Completion Date : December 14, 2018
Actual Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: RSP-14

Comparative study of two Investigational Medical Devices (WM3.4NR and P0.1)

Optical data will be obtained from T1D over a dynamic glycemic range. Data will be paired with references.

 Device: WM3.4NR
The investigational medical device will collect spectral Raman data from tissue.

Device: P0.1
The investigational medical device will collect spectral Raman data from tissue.


Outcome Measures
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Primary Outcome Measures :
  1. Generation and validation of prediction models [ Time Frame: 4 months ]

    Two in-clinic visits each of a duration of 7-8 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM readings. In parallel, optical glucose data from two different prototypes of the investigational medical device will be collected.

    Optical glucose readings will be masked to the subjects.

    Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models from the two devices will be validated on independent data sets using MARD, ISUP and Consensus Error Grid endpoint measures.


  2. Performance evaluation [ Time Frame: 4 months ]
    Validated calibration models will be compared with MARD, ISUP and Consensus Error Grid endpoint measures.


Secondary Outcome Measures :
  1. Safety by paucity of adverse events [ Time Frame: 4 months ]
    To evaluate safety of devices in a descriptive manner by the paucity of adverse events. Adverse events will be recorded during study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female subjects 18 years of age or older
  • Diabetic type 1 patients
  • Insulin pump users
  • Skin phototype 1-4

Exclusion Criteria:

  • For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration
  • For female participants: Breastfeeding
  • Subjects not able to understand and read Danish
  • In Investigator's opinion, subject is not able to follow instructions as specified in the protocol
  • Rejection by optical screenings
  • Subjects not able to hold hand/arm steadily (including tremors and Parkinson's Disease)
  • Diagnosed with reduced circulation
  • Extensive skin changes, tattoos or diseases on probe application site
  • Known allergy to medical grade alcohol
  • Known allergy to adhesives
  • Systemic or topical administration of glucocorticoids for the past 7 days
  • Subjects undergoing dialysis treatment
  • Medical history or any condition that may, in the opinion of the Investigator, compromise the subject's ability to participate
  • Concomitant medical condition which could present a risk to the safety or welfare of the subject or study staff
  • Subjects currently enrolled in another study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03530644


Locations
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Denmark
Steno Diabetes Center Odense
Odense, Denmark, 5000
Sponsors and Collaborators
RSP Systems A/S
Investigators
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Principal Investigator: Jan Erik Henriksen, MD, PhD Steno Diabetes Center Odense, Denmark
Principal Investigator: Vibe Vestergaard, Nurse Steno Diabetes Center Odense, Denmark
More Information
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Responsible Party: RSP Systems A/S
ClinicalTrials.gov Identifier: NCT03530644    
Other Study ID Numbers: RSP-14
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RSP Systems A/S:
Non-invasive glucose monitoring
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases