Calibration of a Non-invasive Glucose Measurement Device and Assessment of Its Performance in the Hypoglycemic Range in Patients With Type 1 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: P0.3

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Gentofte, Denmark, 2820
    • Steno Diabetes Center Copenhagen (SDCC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Protocol 1; 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; Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk/benefit analysis	Support of a favorable risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects.	12 months
Number of encountered Device Deficiencies	Evaluation of Device Deficiencies with respect to identity, quality, durability or reliability, including malfunctions, use errors and inadequate labeling.	12 months

Collaborators and Investigators

• Sponsor: RSP Systems A/S
• Collaborators: Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: Kirsten Nørgaard, Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Non-invasive glucose monitoring; Raman spectroscopy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: RSP-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No