Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry

NCT06088615 | Completed

• 2 other identifiers: IfDT-2325-DECIV-23-08-043757
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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 type 1 and 2.

Conditions

Diabetes Mellitus Type 2; Diabetes Mellitus Type 1; Healthy

Keywords

non-invasive glucose monitoring; photothermal deflectometry

Outcome Measures

Primary Outcomes (1)

• Accuracy of non-invasive glucose measurement in comparison to invasive glucose measurement

  The accuracy of glucose values determined by D-Base 2.0 Prototype B in comparison with Contour Next (CNXT) values (non-invasive vs invasive glucose measurement) is determined by the following specific analysis: * Number and percentage of D-Base 2.0 Prototype B results within ±15 mg/dl or ±15% as well as ±20 mg/dl or ±20% and ±30 mg/dl or ±30% of mean CNXT results for mean CNXT results \<100 mg/dl or ≥100 mg/dl, respectively

  3-13 days per subject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 36 adults with type 1 or 2 diabetes or without diabetes

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diamontech AG: lead
• Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm: collaborator

Study Sites (1)

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

Ulm, Baden-Wurttemberg, 89081, Germany

Location

Related Publications (1)

• Kaluza M, Janik S, Lubinski T, Saita M, Lachmann P, Canini L, Lepro V, Mantele W. Clinical validation of noninvasive blood glucose measurements by midinfrared spectroscopy. Commun Med (Lond). 2025 Nov 15;5(1):509. doi: 10.1038/s43856-025-01241-7.

  PMID: 41258444 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 18, 2023
• Study Start: November 8, 2023
• Primary Completion: April 29, 2024
• Study Completion: April 29, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

DE (1)