NCT04126759

Brief Summary

This clinical study has been launched to collect spectral Raman data and reference measurements to establish and validate a calibration model for the device during daily glycemic fluctuations and evaluate analytical performance of device in the hypoglycemic range. The study is a combined home-based and in-clinic study where subjects will attend the clinic two times.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable diabetes-mellitus

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

July 15, 2019

Last Update Submit

October 6, 2020

Conditions

Diabetes Mellitus

Keywords

Non-invasive glucose monitoringRaman spectroscopy

Outcome Measures

Primary Outcomes (2)

  • Generation of predictive algorithms for determining blood glucose levels

    Collected spectral raman data will found the development of predictive algorithms for glucose determination.

    12 months

  • Validation of predictive algorithms for determining blood glucose levels

    Performance of predictive models will be evaluated using the consensus error grid.Unified Performance (ISUP), Mean Absolute Relative Difference (MARD) and Consensus Error Grid (CEG) distribution.

    12 months

Secondary Outcomes (2)

  • Risk/benefit analysis

    12 months

  • Number of encountered Device Deficiencies

    12 months

Study Arms (1)

Protocol 1

EXPERIMENTAL

The subjects enrolled in this protocol will dedicate 33 days of home-based measurement and two days for in-clinic measurements. For reference measurements, subjects will be equipped with a BG-meter (Contour Next One, Ascenia). Optical measurements are collected with the IMD. Each day of measurements consists of four sessions each comprising two capillary blood glucose measurement with a BG-meter and two IMD measurements. IMD measurements will be performed using the thenar of the right hand of the subject.

Device: P0.3

Interventions

P0.3DEVICE

Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.

Protocol 1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female subjects between 18 and 40 years of age.
  • Diagnosed with type 1 diabetes mellitus.
  • Uses an insulin pen or pump.
  • Hb1Ac \> 55 mmol/mol at baseline visit.
  • Skin phototype 1-4 according to Fitzpatrick skin tone scale.
  • Willing to perform a minimum of 8 finger sticks per day during the study for the home-based study and approximately 16 finger sticks for the in-clinic study days.
  • Willing to have a peripheral venous catheter inserted.
  • Willing to provide written signed and dated informed consent.

You may not qualify if:

  • Breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control according to approved contraceptives from NCA during the study execution (applicable to female subjects only).
  • Subjects not able to understand and read Danish.
  • Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator.
  • Subject is not able to hold hand/arm steadily (including tremors and Parkinson's Disease).
  • Reduced circulation in hand. "Allen's test" is used for assessing hand circulation to evaluate occurrence of reduced blood.
  • Extensive skin changes, tattoos or diseases on probe application site (thenar) that could interfere with the accuracy of the interstitial glucose measurements.
  • Known allergy to medical grade alcohol.
  • Having active cancer treatment and/or use tetracyclines and other medication / topical agents known to increase photosensitivity in skin.
  • 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.
  • Diagnosed with cardiovascular diseases.
  • Subjects currently enrolled in another study.
  • Radiotherapy for the past six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Copenhagen (SDCC)

Gentofte Municipality, 2820, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kirsten Nørgaard

    Steno Diabetes Center Copenhagen

    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

July 15, 2019

First Posted

October 15, 2019

Study Start

July 1, 2019

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)