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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: P0.3


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocol 1<br>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<br>* Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-invasive glucose monitoring, Raman spectroscopy