Status:
COMPLETED
Non-invasive Glucose Measurement With Raman Technology in Patients With Type 1 and Type 2 Diabetes
Lead Sponsor:
RSP Systems A/S
Conditions:
Diabete Mellitus
Medical Device
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study was established to collect data and reference measurements in order to establish calibration models for the Prototype 0.3
Detailed Description
Subjects are recruited at two different sites. Site 1: In group 1 subjects will on their regular stay in the clinic perform four measurement sessions a day. A measurement session consist of a referen...
Eligibility Criteria
Inclusion
- At least 18 years of age
- Have a diagnosis of type 1 or type 2 diabetes mellitus (for RSP-09-02, only patients with type 1 diabetes)
- Skin phototype 1-4
- Be willing to perform a minimum of 6 / 12 (31 during excursion days) finger sticks per day during the study
- Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol
- Be willing to provide written signed and dated informed consent
Exclusion
- Inability to comply with the study procedures as described by the study protocol, according to the opinion of the investigator, due to e.g. known psychiatric diagnoses, lack of cognitive ability, alcohol dependency, drug use, psychosocial overload
- Have known severe allergy to medical grade adhesive or isopropyl alcohol used to clean the skin
- Be breastfeeding, pregnant, attempting to conceive or not willing and able to practice birth control during the study execution (applicable to female subjects only)
- Unable to hold hand/arm steadily (including tremors and Parkinson's Disease)
- 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)
- Systemic or topical administration of glucocorticoids for the past 7 days
- Undergoing dialysis treatment
- Have extensive skin changes/diseases at the proposed measurement site (thenar) that could interfere with the accuracy of interstitial glucose measurements
- Have a concomitant medical condition which could interfere with the study devices (study arm 1: intake of acetaminophen study arm 2: intake of salicylic acid or higher doses of ascorbic acid)
- Unsuitable for participation due to any other cause as determined by the Investigator. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation e.g. with required documentation
- Dependency from the sponsor or the clinical investigator (e.g. co-workers of the sponsor, the study site, and/ or their families)
- Additional exclusion criteria for study arm 2:
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Hypoglycemia unawareness
Key Trial Info
Start Date :
November 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03781232
Start Date
November 22 2018
End Date
August 5 2019
Last Update
December 4 2019
Active Locations (2)
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1
m&i-Fachklinik Bad Heilbrunn - Zentrum für Diabetes und Stoffwechselerkrankungen
Bad Heilbrunn, Germany, 83670
2
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Germany, 89081