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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126759
• Other study ID #: RSP-17
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2020
• Source: RSP Systems A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• P0.3
Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen (SDCC)	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
RSP Systems A/S	Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Risk/benefit analysis	Support of a favorable risk/benefit analysis based on reported Adverse Device Effects and Serious Adverse Device Effects.	12 months
Secondary	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