Background: Sensor augmented pump therapy (SAPT) comprising an insulin pump associated with a real time-continuous glucose monitor (RT-CGM) represents the most advanced technology currently available for managing glycaemia in people with Type 1 diabetes. However, the patient still needs to calculate mealtime carbohydrates and program the pump to deliver insulin after reviewing CGM information. A Closed Loop (CL) system automatically links insulin delivery and the glucose sensing components of SAPT using a computerised algorithm. The JDRF sponsored Australian at Home Overnight Closed Loop Study currently underway is evaluating an overnight CL system (Android System; Medtronic) in comparison with SAPT in both hospital and home environments.
Aim: This presentation describes the role of a Diabetes Nurse Educator (DNE) working as a research coordinator in a CL study and the challenges faced within that role.
Observations: The research coordinator requires advanced skills in both research coordination and diabetes education, including extensive experience in Continuous Subcutaneous Insulin infusion (CSII) and CGM management. Protocol development, ethics submissions, patient management, study team coordination and sample collection/ processing are integral to this role.
Challenges:
• Understanding of governance and legislation surrounding research with regard to ethics submission.
• Technical knowledge – understanding the use of and trouble shooting CL system and android devices used for remote monitoring and uploading of data from these devices.
• Laboratory skills – blood collection, serum aliquot preparation, YSI glucose analyser operation and trouble-shooting.
• Coordinating study participants and team members at multiple sites and material resources.
Conclusion: The DNE working as a CL research coordinator requires unique skills. With expertise underpinned by extensive knowledge of CSII and CGM and diligent preparation, the DNE is pivotal to the success of CL clinical research.