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

NCT03530644 | Completed

• 1 other identifier: RSP-14
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type1diabetes

Keywords

Non-invasive glucose monitoring

Outcome Measures

Primary Outcomes (2)

• 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.

  4 months

• Performance evaluation

  Validated calibration models will be compared with MARD, ISUP and Consensus Error Grid endpoint measures.

  4 months

Secondary Outcomes (1)

• Safety by paucity of adverse events

  4 months

Study Arms (1)

RSP-14

EXPERIMENTAL

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; Device: P0.1

Interventions

WM3.4NR DEVICE

The investigational medical device will collect spectral Raman data from tissue.

RSP-14

P0.1 DEVICE

The investigational medical device will collect spectral Raman data from tissue.

RSP-14

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RSP Systems A/S: lead

Study Sites (1)

Steno Diabetes Center Odense

Odense, 5000, Denmark

Location

Study Officials

• Jan Erik Henriksen, MD, PhD

  Steno Diabetes Center Odense, Denmark

  PRINCIPAL INVESTIGATOR

• Vibe Vestergaard, Nurse

  Steno Diabetes Center Odense, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 21, 2018
• Study Start: August 28, 2018
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)