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Completed

NCT Number: NCT03782649

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Working Model 3.4NR

Device

Investigational Medical Device collecting spectral Raman data from tissue

Primary outcomes

  1. Generation and validation of prediction models - MARD

    Time frame: One year

    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.

  2. Generation and validation of prediction models - ISUP

    Time frame: One year

    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.

  3. Generation and validation of prediction models - Consensus Error Grid

    Time frame: One year

    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

Secondary outcomes

  1. Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels

    Time frame: One year

    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.

  2. Safety evaluation: paucity of adverse events

    Time frame: One year

    Safety will be evaluated in a descriptive manner by the paucity of adverse events

Sponsors and collaborators

Lead sponsor

RSP Systems A/S

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2018
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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