Status:
COMPLETED
Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry
Lead Sponsor:
Diamontech AG
Collaborating Sponsors:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Conditions:
Diabetes Mellitus Type 2
Diabetes Mellitus Type 1
Eligibility:
All Genders
18+ years
Brief Summary
This study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus...
Detailed Description
The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects without diabetes and with type 1 or 2 diabetes mellitus (any therapy form). The ...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 OR type 2 diabetes OR no diabetes
- For subjects with diabetes: glycated haemoglobin (HbA1c) \<10%
- Age ≥ 18 years
- Male or female or diverse
- An understanding of and willingness to follow the protocol
- Signed informed consent
Exclusion
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
- Hypoglycemia unawareness
- Have extensive skin changes/diseases at the proposed measurement site (wrist and upper arm for FreeStyle Libre 3) that could interfere with the accuracy of glucose measurements.
- Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
- Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
- Severe diabetes related complications (i.e. macro angiopathy, severe micro angiopathy, severe neuro-, retino- or nephropathy) when unstable (defined by event or increasing symptoms in the last 6 months) or with insufficient therapy
- Known severe tape reactions or allergies
- Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, tremor, language barriers, alcohol or drug misuse
- Not able to understand, write or read German
- Dependency from the sponsor or the clinical investigator
Key Trial Info
Start Date :
November 8 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 29 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06088615
Start Date
November 8 2023
End Date
April 29 2024
Last Update
August 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, Germany, 89081