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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05169034
Recruitment Status : Terminated (Goals as defined in the study protocol were not met after the first study period. Study with improved device will follow.)
First Posted : December 23, 2021
Last Update Posted : May 16, 2023
Sponsor:
Collaborator:
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Information provided by (Responsible Party):
Diamontech AG

Study Description
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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
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

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
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Study Type : Observational
Actual Enrollment : 25 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 : December 14, 2021
Actual Primary Completion Date : August 30, 2022
Actual Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. System Performance [ Time Frame: 1 week per subject ]
    Accuracy of glucose values determined with the device in comparison with values from a standard glucometer


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Up to 100 adults with type 1 or type 2 diabetes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05169034


Locations
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Germany
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
More Information
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Responsible Party: Diamontech AG
ClinicalTrials.gov Identifier: NCT05169034    
Other Study ID Numbers: IfDT-2012-DE
First Posted: December 23, 2021    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: February 2023

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases