E14
Conditions
Interventions
Group 1: single-arm: Persons with Diabetes mellitus Type 1 will come to the study site on 3 days. On all 3 days, one arm will be heated with a heating pad to “arterialize” the venous blood. Study pro
Sponsors
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of type 1 diabetes for at least 6 months - 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 - Clinically relevant anemia - Known severe skin reactions or allergies to medical adhesives - History of frequent catheter abscesses associated with pump therapy - Infection with hepatitis B, C or HIV - 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 - Intake of anticoagulant medication (with the exception of ASS 100) - Known coagulation disease - 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, language barriers, alcohol or drug misuse - Dependency from the sponsor or the clinical investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the study is to investigate in an exploratory manner the effect of arterializing venous blood using a heating method on glucose concentrations in comparison to venous and capillary samples. The hypothesis is that arterialized-venous glucose concentrations are similar to capillary glucose concentrations and, thus, substantially higher than native venous glucose concentrations. Co-primary endpoints: Difference between venous and arterialized-venous glucose concentrations - for deproteinized whole blood measured with Cobas 6000 c501 - for plasma measured with Cobas 6000 c501 - for plasma measured with YSI 2300 STAT Plus | — |
Secondary
| Measure | Time frame |
|---|---|
| - Difference between capillary and venous and arterialized-venous glucose concentrations measured with BGMS - Difference between arterialized-venous and venous glucose concentrations stratified by type of glucose challenge - Difference between glucose concentrations in the dominant and in the non-dominant arm, for each method separately - Difference between CGM values and venous and arterialized-venous glucose concentrations measured with the other devices. - Difference between CGM values on the two arms, both without and with arterialization, to assess the impact of arterialization on the CGM values | — |
Countries
Germany
Contacts
Public ContactManuela Link
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)
Outcome results
None listed