Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry

August 27, 2024 updated by: Diamontech AG
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.

Study Overview

Status

Completed

Conditions

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)

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of non-invasive glucose measurement in comparison to invasive glucose measurement
Time Frame: 3-13 days per subject

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diamontech AG

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2023

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

April 29, 2024

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IfDT-2325-DE
  • CIV-23-08-043757 (Other Identifier: EUDAMED)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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