Diabetes Mellitus, Type 1NCT05169034
Feasibility Study of Blood Glucose Monitoring With the Non-invasive Medical Device D-Base
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Diamontech AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 14 Dec 2021to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 100 adults with type 1 or type 2 diabetes
Who may be able to join
- Clinical diagnosis of type 1 or type 2 diabetes
- HbA1c <10%
- An understanding of and willingness to follow the protocol
- Signed informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Ulm, Baden-Wurttemberg, 89081
About this study
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
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.
Read the 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.
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
System Performance
Accuracy of glucose values determined with the device in comparison with values from a standard glucometer
Measured: 1 week per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start14 Dec 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
Why it stopped: Goals as defined in the study protocol were not met after the first study period. Study with improved device will follow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diamontech AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169034
- Sponsor's protocol ID
- IfDT-2012-DE
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2021
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05169034
- Acronym / sponsor ID
- IfDT-2012-DE
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Goals as defined in the study protocol were not met after the first study period. Study with improved device will follow.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Diamontech AGIndustry (pharma, biotech, devices)
- Collaborators
- Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 adults with type 1 or type 2 diabetes
Key inclusion criteria (4 listed)
- Clinical diagnosis of type 1 or type 2 diabetes
- HbA1c <10%
- An understanding of and willingness to follow the protocol
- Signed informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
System Performance
Time frame: 1 week per subject
Accuracy of glucose values determined with the device in comparison with values from a standard glucometer
Results and safety
The study was stopped early (reason given: Goals as defined in the study protocol were not met after the first study period. Study with improved device will follow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Diamontech AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Goals as defined in the study protocol were not met after the first study period. Study with improved device will follow.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Performance (time frame: 1 week per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.