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

NCT ID: NCT05169034

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2022-08-30

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.

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.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: collaborator

Diamontech AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Ulm, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

IfDT-2012-DE

Identifier Type: -

Identifier Source: org_study_id