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NCT06088615Completed

Feasibility of Non-invasive Glucose Monitoring by Using Photothermal Deflectometry

Source: ClinicalTrials.gov · Last updated 28 Aug 2024

Brief summary (registry, in English)

This study aims to evaluate the feasibility of non-invasive glucose monitoring by using photothermal deflectometry in the interstitial fluid of the skin on the wrist of subjects with diabetes mellitus type 1 and 2.

Status (registry)
Completed
Study type
Observational
Enrollment
36 (actual)
First submitted
19 Sept 2023
Start date
8 Nov 2023
Primary completion date
29 Apr 2024
Lead sponsor
Diamontech AG
NCT number
NCT06088615

What you commit to

  • Study type: Observational
  • Participants enrolled: 36
  • From 8 Nov 2023 to the primary completion date, 29 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment

Other illness

  • 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. 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
  • Known severe tape reactions or allergies
  • 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

Lab values

  • Have extensive skin changes/diseases at the proposed measurement site (wrist and upper arm for FreeStyle Libre 3) that could interfere with the accuracy of glucose measurements.

Other

  • Hypoglycemia unawareness
  • Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy)
  • Not able to understand, write or read German
  • Dependency from the sponsor or the clinical investigator

Who the study is looking for

  • Clinical diagnosis of type 1 OR type 2 diabetes OR no diabetes
  • For subjects with diabetes: glycated haemoglobin (HbA1c) \<10%
  • Age ≥ 18 years
  • Male or female or diverse
  • An understanding of and willingness to follow the protocol
  • Signed informed consent

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Coordinator of this site? Confirm its status
UlmGermanyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.