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

Terminated

• Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

• Registration Number: NCT05169034
• Lead Sponsor: Diamontech AG

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.

Study Timeline

• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study Start: 2021-12-14
• Study First Posted: 2021-12-23
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-05-15
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
System Performance	1 week per subject	Accuracy of glucose values determined with the device in comparison with values from a standard glucometer

Trial Locations

Locations (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm; 🇩🇪 Ulm, Baden-Württemberg, Germany