NCT05169034

Terminated

Feasibility Study of Blood Glucose Monitoring With the Non-i...

Diamontech AG Source

Diamontech AG

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

IfDT-2012-DE

Study Type

observational

Actual enrollment (reported)

25

Locations

1 country

Sites

1

Timeline

Study Start

December 14, 2021

Actual (reported)

Primary Completion

August 30, 2022

Actual (reported)

Study Completion

August 30, 2022

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: terminated
Actual enrollment (reported): 25 participants
Study completion date: August 30, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 9, 2021
Actual (reported)
Study Start
December 14, 2021
Actual (reported)
First Posted
December 23, 2021
Actual (reported)
Primary Completion
August 30, 2022
Actual (reported)
Study Completion
August 30, 2022
Actual (reported)

Last Updated: May 16, 2023
Status Verified: February 2023
Last Update Submitted: May 15, 2023

Conditions

Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Up to 100 adults with type 1 or type 2 diabetes

You may qualify if:

Clinical diagnosis of type 1 or type 2 diabetes

Sponsors & Collaborators

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

Study Sites (1)

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

Ulm, Baden-Wurttemberg, 89081, Germany

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: CASE ONLY
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 23, 2021

Study Start

December 14, 2021

Actual (reported)

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Unknown

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Withdrawn

NCT05229445

A Continuous Glucose Monitor Based Insulin Bolus Calculator

Not ApplicableCompleted

NCT04217369

Impacts of Glucose Forecasting

Not ApplicableUnknown

NCT04698018

A Research Study to Look at How Faster Aspart Works in Chinese People With Type 1 Diabetes or Type 2 Diabetes

Phase 1Completed

NCT05644730

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Not ApplicableCompleted

HbA1c \<10%

An understanding of and willingness to follow the protocol

Signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

August 30, 2022

Actual (reported)

Study Completion

August 30, 2022

Actual (reported)

Last Updated

May 16, 2023

Record last verified: 2023-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05169034
Data provider: ClinicalTrials.gov
Source updated: 2023-05-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:36:55 UTC

Locations

DE(1)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations