Comparing Home Self-Collected and Clinic Venous Blood Tests for Diabetes Monitoring Including HbA1c, Cholesterol, and Thyroid Function

What this Trial Is About

Diabetes mellitus requires regular monitoring of blood sugar control to reduce the risk of complications. This research aims to compare the standard venous blood draw done in clinics with a home-based self-collection method for measuring HbA1c, cholesterol lipids, and thyroid function. The goal is to assess the accuracy, patient acceptance, and economic impact of collecting blood samples at home using capillary blood sampling. Participants will first visit the clinic where a venous blood sample will be taken by a nurse. They will then be randomly assigned to collect a capillary blood sample either by finger prick or an upper arm device while at the clinic. After training, participants will perform the same type of blood collection at home within two days of their clinic visit and mail the sample to a central laboratory. Questionnaires will be completed after each blood collection to evaluate ease of use and patient preferences. During the study, researchers will track sample collection success, temperature during shipping, and any issues with self-collection. Participants will be monitored for 12 months, with outcomes focusing on HbA1c, lipids, thyroid function, patient acceptance, and health economics. Participants will also receive compensation for travel and inconvenience. Confidentiality and data protection will be maintained according to regulations throughout the study.

Convenient Home Access for Routine Monitoring in Diabetes (Charm-D Study)