Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry

NCT06088615•Diamontech AG

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 type 1 and 2.

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 clinical investigation will be performed in an outpatient setting on up to three study days with up to 36 subjects. At least 6 subjects shall be included in each of the three subgroups (type 1 diabetes, type 2 diabetes, no diabetes)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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 Criteria

•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

Locations (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, Baden-Wurttemberg, Germany

Key Dates

Start Date

November 8, 2023

Primary Completion Date

April 29, 2024

Completion Date

April 29, 2024

Last Updated

August 28, 2024

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus Type 2Diabetes Mellitus Type 1Healthy

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry

Inclusion Criteria

Exclusion Criteria

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