Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References

Diabetes Mellitus Clinical Trial

Official title:

Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782649
• Other study ID #: RSP-08
• Status: Completed
• Phase: N/A
• Start date: November 29, 2018
• Est. completion date: June 19, 2019

Study information

• Verified date: December 2019
• 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 on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.

Description:

Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male and female subjects 18-70 years old

• Patients diagnosed with type 1 or type 2 diabetes (T1D or T2D) (insulin requiring T2D patients)

• Diabetes management strategy: lifestyle regimen + insulin ± oral hypoglycemic agents

• Skin phototype 1-4

Exclusion Criteria:

• For female participants: Pregnancy or subject is attempting to conceive or not willing and able to practice birth control during the study duration

• > 10 cigarettes pr. day

• Participants not able to understand and read Swedish

• In investigator's opinion, participant is not able to follow instructions as specified in the protocol

• Participants 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

• Rejection by screening optical measurements

• Known allergy to medical grade alcohol

• Known allergy to adhesives

• Systemic or topical administration of glucocorticoids for the past 7 days

• Participants undergoing dialysis treatment

• Anti-coagulation or anti-platelet therapy

• Use of beta-blockers

• Medical conditions causing bleeding tendency

• 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. Such conditions include but are not limited to HIV and Hepatitis B or C.

• Participants currently enrolled in another study

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Working Model 3.4NR
Investigational Medical Device collecting spectral Raman data from tissue

Locations

Country	Name	City	State
Sweden	Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
RSP Systems A/S

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generation and validation of prediction models - MARD	Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure.	One year
Primary	Generation and validation of prediction models - ISUP	Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure.	One year
Primary	Generation and validation of prediction models - Consensus Error Grid	Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from 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 will be validated on independent data sets using Consensus Error Grid Analysis	One year
Secondary	Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels	Two in-clinic visits each of a duration of 5-6 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 and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected.; Optical glucose readings will be masked to the subjects.; A modeling-based evaluation of the dynamics between blood glucose and tissue glucose will be conducted and serve as a secondary endpoint of the study.	One year
Secondary	Safety evaluation: paucity of adverse events	Safety will be evaluated in a descriptive manner by the paucity of adverse events	One year