Feasibility Study of Blood Glucose Monitoring With the Non-invasive Medical Device D-Base

Sponsor
Diamontech AG (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05169034
Collaborator
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (Other)
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Study Details

Study Description

Brief Summary

This study aims to evaluate the feasibility of monitoring the blood glucose values by measuring the glucose in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The investigation is designed as an open, monocentric, non-randomized, single-arm, explorative study in adult subjects with type 1 or 2 diabetes mellitus (any therapy form).

    The clinical investigation will be performed in an outpatient setting on up to two study days with up to 100 subjects. A nearly equal number of subjects with diabetes type 1 and 2 shall participate in the study.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Feasibility of Predicting Blood Glucose Values by Measuring in the Interstitial Fluid of the Skin on the Wrist With the Non-invasive Medical Device D-Base
    Actual Study Start Date :
    Dec 14, 2021
    Anticipated Primary Completion Date :
    May 1, 2022
    Anticipated Study Completion Date :
    May 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. System Performance [1 week per subject]

      Accuracy of glucose values determined with the device in comparison with values from a standard glucometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Clinical diagnosis of type 1 or type 2 diabetes

    • HbA1c <10%

    • 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) 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. severe 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

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm Ulm Baden-Württemberg Germany 89081

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Diamontech AG
    ClinicalTrials.gov Identifier:
    NCT05169034
    Other Study ID Numbers:
    • IfDT-2012-DE
    First Posted:
    Dec 23, 2021
    Last Update Posted:
    Jan 12, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 12, 2022