DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT05803473
• Lead Sponsor: Peter Kristensen

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-07
• Study Start: 2023-04-11
• Status Verified: 2024-03
• Primary Completion: 2024-03-29
• Study Completion: 2024-07-29
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time in range	During hospitalization (up to 30 days)	Time in range (TIR) is defined as the percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.

Secondary Outcome Measures

Name	Time	Method
Time below range (TBR) <3.0 (<54 mg/dL)	During hospitalization (up to 30 days)	Percentage of time below range; amount of time (hours and minutes)
Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)	During hospitalization (up to 30 days)	mmol/L (mg/dL), duration ≥15 consecutive min.
Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL)	During hospitalization (up to 30 days)	Percentage of time in range assessed each day of inclusion; amount of time (hours and minutes).
Standard deviation (SD) of all CGM glucose levels	During hospitalization (up to 30 days)	mmol/L (mg/dL)
Mean glucose levels	During hospitalization (up to 30 days)	mmol/L (mg/dL)
Time above range (TAR) >10.0 mmol/L (>180 mg/dL)	During hospitalization (up to 30 days)	Percentage of time above range; amount of time (hours and minutes).
Coefficient of variation (CV)	During hospitalization (up to 30 days)	SD divided by mean glucose level
Time above range (TAR) >13.9 mmol/L (>250 mg/dL)	During hospitalization (up to 30 days)	Percentage of time above range; amount of time (hours and minutes).
Time below range (TBR) <3.9 mmol/L (<70 mg/dL)	During hospitalization (up to 30 days)	Percentage of time below range; amount of time (hours and minutes)
Hypoglycemia (level 1) 3.0-3.8 mmol/L (54-69 mg/dL)	During hospitalization (up to 30 days)	mmol/L (mg/dL), duration ≥15 consecutive min.
Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)	During hospitalization (up to 30 days)	mmol/L (mg/dL), duration ≥15 consecutive min.
Recurrent hypoglycemic events	During hospitalization (up to 30 days)	Number; Reoccurring hypoglycemic events after the first episode of hypoglycemia.

Trial Locations

Locations (2)

Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen); 🇩🇰 Herlev, Denmark

Copenhagen University Hospital - North Zealand; 🇩🇰 Hillerød, Denmark