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

BMC Endocr Disord. 2024 May 6;24(1):60. doi: 10.1186/s12902-024-01595-4.

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 27th 2023.

Keywords: Continuous glucose monitoring; Diabetes; In-hospital; Inpatient; RCT.

Publication types

  • Randomized Controlled Trial
  • Clinical Trial Protocol
  • Multicenter Study

MeSH terms

  • Adult
  • Blood Glucose Self-Monitoring* / methods
  • Blood Glucose* / analysis
  • Continuous Glucose Monitoring
  • Diabetes Mellitus, Type 2* / blood
  • Diabetes Mellitus, Type 2* / diagnosis
  • Female
  • Hospitalization
  • Humans
  • Hypoglycemic Agents / therapeutic use
  • Insulin / administration & dosage
  • Insulin / therapeutic use
  • Male
  • Middle Aged
  • Patient Care Team
  • Point-of-Care Testing
  • Prospective Studies

Substances

  • Blood Glucose
  • Insulin
  • Hypoglycemic Agents

Associated data

  • ClinicalTrials.gov/NCT05803473