Diabetes Mellitus
Conditions
Keywords
Non-invasive glucose monitoring, Raman spectroscopy
Brief summary
This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.
Interventions
DEVICEPrototype 0.5
Investigational Medical Device collecting Raman data from tissue
Sponsors
RSP Systems A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female subjects minimum 18 years of age * Individuals diagnosed with any type of insulin-dependent diabetes mellitus ≥ 1 year * Willing to perform up to 12 finger-pricks during each day of out-patient measurements * Signed informed consent * For women of childbearing potential: Willing and able to practice FDA approved birth control during the duration of the investigation * Subject has a 2.4 GHz wireless internet connection at home (standard in normal routers) to be used in the study
Exclusion criteria
* For female subjects: Pregnancy or breastfeeding * Skin phototype VI categorized by Fitzpatrick scale measured on thenar * Subjects not able to understand and read local language * Cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the protocol * Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease) * Extensive skin changes, tattoos or diseases on right thenar (measurement site) * Reduced circulation in right hand evaluated by Allen's test * Known allergy to medical grade alcohol * Hemodialysis * Systemic or topical administration of glucocorticoids at the right hand for the past 7 days or during the study period expected * Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol * Severe diabetes-related complications such as advanced autonomic neuropathy, kidney disease, foot ulcers, legal blindness, or symptomatic cardiovascular disease as evidenced by a history of cardiovascular episode(s) * Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families) * Subjects currently participating in another study * Subjects who have participated in the study IDT-1904-RO/RSP-21 or RSP-19. * Incapacity for consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of number of calibration days | 2 years | The number of calibration days needed for reaching a well-performing glucose predictive calibration model will be determined. The clinical performance of the reduced calibration model will be based on the data from the validation part by studying linear regression, Inter Subject Unified Performance value and Consensus Error Grid. |
| Safety evaluation of the Investigational Medical Device by reporting of adverse events | 2 years | Safety of the IMD will be evaluated in a descriptive manner by the paucity of adverse events reported during the clinical investigation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device function | 2 years | Device function will be evaluated in regard to durability and reliability. This is evaluated by reported device deficiencies during the study in the terms of subject diaries |
Countries
Germany
Outcome results
None listed