Study Stopped
Goals as defined in the study protocol were not met after the first study period. Study with improved device will follow.
Feasibility Study of Blood Glucose Monitoring With the Non-invasive Medical Device D-Base
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
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2021
CompletedStudy Start
First participant enrolled
December 14, 2021
CompletedFirst Posted
Study publicly available on registry
December 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedMay 16, 2023
February 1, 2023
9 months
December 9, 2021
May 15, 2023
Conditions
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
Up to 100 adults with type 1 or type 2 diabetes
You may qualify if:
- Clinical diagnosis of type 1 or type 2 diabetes
- 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.
Sponsors & Collaborators
Study Sites (1)
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, 89081, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
Primary Completion
August 30, 2022
Study Completion
August 30, 2022
Last Updated
May 16, 2023
Record last verified: 2023-02