1. Summary of clinical investigation plan for The DIATEC trial: in-hospital diabetes management by a diabetes team and continuous glucose monitoring or point of care glucose testing - a randomised controlled trial.
- Author
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Olsen MT, Klarskov CK, Pedersen-Bjergaard U, Hansen KB, and Kristensen PL
- Subjects
- Adult, Female, Humans, Male, Middle Aged, Blood Glucose analysis, Hospitalization, Hypoglycemic Agents therapeutic use, Insulin therapeutic use, Insulin administration & dosage, Patient Care Team, Point-of-Care Testing, Prospective Studies, Randomized Controlled Trials as Topic, Multicenter Studies as Topic, Continuous Glucose Monitoring, Diabetes Mellitus, Type 2 diagnosis, Diabetes Mellitus, Type 2 blood
- Abstract
Background: Worldwide, up to 20 % of hospitalised patients have diabetes mellitus. In-hospital dysglycaemia increases patient mortality, morbidity, and length of hospital stay. Improved in-hospital diabetes management strategies are needed. The DIATEC trial investigates the effects of an in-hospital diabetes team and operational insulin titration algorithms based on either continuous glucose monitoring (CGM) data or standard point-of-care (POC) glucose testing., Methods: This is a two-armed, two-site, prospective randomised open-label blinded endpoint (PROBE) trial. We recruit non-critically ill hospitalised general medical and orthopaedic patients with type 2 diabetes treated with basal, prandial, and correctional insulin (N = 166). In both arms, patients are monitored by POC glucose testing and diabetes management is done by ward nurses guided by in-hospital diabetes teams. In one of the arms, patients are monitored in addition to POC glucose testing by telemetric CGM viewed by the in-hospital diabetes teams only. The in-hospital diabetes teams have operational algorithms to titrate insulin in both arms. Outcomes are in-hospital glycaemic and clinical outcomes., Discussion: The DIATEC trial will show the glycaemic and clinical effects of in-hospital CGM handled by in-hospital diabetes teams with access to operational insulin titration algorithms in non-critically ill patients with type 2 diabetes. The DIATEC trial seeks to identify which hospitalised patients will benefit from CGM and in-hospital diabetes teams compared to POC glucose testing. This is essential information to optimise the use of healthcare resources before broadly implementing in-hospital CGM and diabetes teams., Trial Registration: Prospectively registered at ClinicalTrials.gov with identification number NCT05803473 on March 27
th 2023., (© 2024. The Author(s).)- Published
- 2024
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