Effect of heating of the arm (arterialization of venous blood) on venous blood glucose concentratio

Completed

• Conditions: E14; Unspecified diabetes mellitus

• Registration Number: DRKS00031197
• Lead Sponsor: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-31
• Study Completion: 2023-02-03
• Results First Posted: 2023-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Co-primary endpoints:<br>Difference between venous and arterialized-venous glucose concentrations<br>- for deproteinized whole blood measured with Cobas 6000 c501<br>- for plasma measured with Cobas 6000 c501<br> - for plasma measured with YSI 2300 STAT Plus

Secondary Outcome Measures

Name	Time	Method
- Difference between capillary and venous and arterialized-venous glucose concentrations measured with BGMS<br>- Difference between arterialized-venous and venous glucose concentrations stratified by type of glucose challenge<br>- Difference between glucose concentrations in the dominant and in the non-dominant arm, for each method separately<br>- Difference between CGM values and venous and arterialized-venous glucose concentrations measured with the other devices.<br>- Difference between CGM values on the two arms, both without and with arterialization, to assess the impact of arterialization on the CGM values