DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes

In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial

This trial investigates the effects of continuous glucose monitoring (CGM) and an in-hospital diabetes team on in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard glucose point-of-care (POC) testing and an in-hospital diabetes team.

In Denmark and worldwide, 15-20 % of hospitalised patients have diabetes mellitus. For most patients, diabetes is not the primary cause of admission. The patients are therefore under the care of non-diabetes specialists. Consequently, diabetes management can be inadequate resulting in hypoglycemia, hyperglycemia, and increased glycemic variability, which might increase patient mortality, morbidity, and length of hospital stay. Despite these challenges, a recent review concludes that in-hospital diabetes management is under-researched. Therefore, new in-hospital diabetes management strategies are greatly needed.

Continuous glucose monitoring (CGM) might accommodate this need by providing 288 glucose readings per day compared to usual glucose point-of-care (POC) testing from finger-prick blood 3-5 times per day during admission. CGM glucose levels can be transmitted from the patient's room to a monitoring screen at the nursing stations. This setup is called telemetric CGM. Outstanding results on glycemic and clinical outcomes in an out-hospital setting exist, however, In-hospital CGM has been associated only with a clinically insignificant reduction of mean daily glucose levels and a small increased detection rate of hypoglycemia of glucose levels <3 mmol/L (<54 mg/dL) compared to POC. Reasons for this might be that an in-hospital diabetes team (i.e., educated diabetes nurses with CGM competencies) is imperative in achieving optimal use of telemetric CGM.

This trial investigates if telemetric CGM and an in-hospital diabetes team improve patients' in-hospital glycemic and clinical outcomes compared to POC glucose testing and an in-hospital diabetes team

Inclusion Criteria:

• A documented history of T2DM prior to inclusion
• Age ≥ 18 years old
• Willingness and ability to comply with the clinical investigation plan
• Ability to communicate in Danish with the trial personnel
• An expected length of hospital stay for at least two days after enrolment
• If subject with childbearing potential (subject < 50 years old); willing to have a urine pregnancy test performed and/or to use a highly effective method of contraception (i.e., birth control implant, intrauterine device, birth control shot, or sterilisation).

Exclusion Criteria:

• Patients on out-hospital basal insulin with duration of action > 24 hours (Toujeo or Tresiba)
• Treated with hydroxyurea/hydroxycarbamid
• Nutritional therapy (continuous enteral or parenteral feeding)
• Clinically relevant pancreatic disease
• Systemic glucocorticoid treatment with prednisone equivalent dose >5 mg/day
• Expected to require admission to the intensive-care unit
• Anasarca (severe and general edema)
• Dialysis
• Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2
• Known hypersensitivity to the band-aid of the CGM Dexcom G6 sensor.