search
Back to results

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

Primary Purpose

Type1diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
WM3.4NR
P0.1
Sponsored by
RSP Systems A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Type1diabetes focused on measuring Non-invasive glucose monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Steno Diabetes Center Odense

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RSP-14

Arm Description

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.

Outcomes

Primary Outcome Measures

Generation and validation of prediction models
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.
Performance evaluation
Validated calibration models will be compared with MARD, ISUP and Consensus Error Grid endpoint measures.

Secondary Outcome Measures

Safety by paucity of adverse events
To evaluate safety of devices in a descriptive manner by the paucity of adverse events. Adverse events will be recorded during study.

Full Information

First Posted
April 11, 2018
Last Updated
December 18, 2018
Sponsor
RSP Systems A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT03530644
Brief Title
Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device
Official Title
Comparative Study Between Two Models of a Non-invasive Glucose Monitoring Device
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
December 14, 2018 (Actual)
Study Completion Date
December 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RSP Systems A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
Non-invasive glucose monitoring

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RSP-14
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
WM3.4NR
Intervention Description
The investigational medical device will collect spectral Raman data from tissue.
Intervention Type
Device
Intervention Name(s)
P0.1
Intervention Description
The investigational medical device will collect spectral Raman data from tissue.
Primary Outcome Measure Information:
Title
Generation and validation of prediction models
Description
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.
Time Frame
4 months
Title
Performance evaluation
Description
Validated calibration models will be compared with MARD, ISUP and Consensus Error Grid endpoint measures.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Safety by paucity of adverse events
Description
To evaluate safety of devices in a descriptive manner by the paucity of adverse events. Adverse events will be recorded during study.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Erik Henriksen, MD, PhD
Organizational Affiliation
Steno Diabetes Center Odense, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vibe Vestergaard, Nurse
Organizational Affiliation
Steno Diabetes Center Odense, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center Odense
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs