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

NCT ID: NCT03782649

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2019-06-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Keywords

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Non-invasive glucose monitoring Raman spectroscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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RSP-08

All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection.

Group Type EXPERIMENTAL

Working Model 3.4NR

Intervention Type DEVICE

Investigational Medical Device collecting spectral Raman data from tissue

Interventions

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Working Model 3.4NR

Investigational Medical Device collecting spectral Raman data from tissue

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RSP Systems A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per-Anders Jansson, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska Universitetssjukhuset, Gothenburg

Locations

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Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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RSP-08

Identifier Type: -

Identifier Source: org_study_id