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TerminatedNCT05169034Updated May 16, 2023

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

An observational study in Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, sponsored by Diamontech AG. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Diamontech AG · Observational

Why this study was terminated
Goals as defined in the study protocol were not met after the first study period. Study with improved device will follow.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1
  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 25 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Diamontech AG is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Up to 100 adults with type 1 or type 2 diabetes

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. System Performance

    Accuracy of glucose values determined with the device in comparison with values from a standard glucometer

    Time frame: 1 week per subject

07

Study locations

1 site
  • Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
    Ulm, Baden-Württemberg 89081, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05169034
Lead sponsor
Diamontech AG
Collaborators
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Responsible party
Sponsor
First posted
Dec 23, 2021
Start date
Dec 14, 2021
Primary completion
Aug 30, 2022
Completion
Aug 30, 2022
Last update
May 16, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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