Clinical trial NCT05803473: DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes
Official title: In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Inpatient
Randomised controlled trial
Hyperglycemia
Hypoglycemia
Glycemic variabiity
Continuous glucose monitoring
CGM
In-hospital
Telemetric continuous glucose monitoring
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an investigator-initiated, two-site, prospective randomised open-label blinded endpoint (PROBE) trial.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Time in range
timeFrame: During hospitalization (up to 30 days)
Secondary outcomes:
measure: Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL)
timeFrame: During hospitalization (up to 30 days)
measure: Time above range (TAR) >10.0 mmol/L (>180 mg/dL)
timeFrame: During hospitalization (up to 30 days)
measure: Time above range (TAR) >13.9 mmol/L (>250 mg/dL)
timeFrame: During hospitalization (up to 30 days)
measure: Time below range (TBR) <3.9 mmol/L (<70 mg/dL)
timeFrame: During hospitalization (up to 30 days)
measure: Time below range (TBR) <3.0 (<54 mg/dL)
timeFrame: During hospitalization (up to 30 days)
measure: Standard deviation (SD) of all CGM glucose levels
timeFrame: During hospitalization (up to 30 days)
measure: Coefficient of variation (CV)
timeFrame: During hospitalization (up to 30 days)
measure: Mean glucose levels
timeFrame: During hospitalization (up to 30 days)
measure: Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)
timeFrame: During hospitalization (up to 30 days)
measure: Hypoglycemia (level 1) 3.0-3.8 mmol/L (54-69 mg/dL)
timeFrame: During hospitalization (up to 30 days)
measure: Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)
timeFrame: During hospitalization (up to 30 days)
measure: Recurrent hypoglycemic events
timeFrame: During hospitalization (up to 30 days)
Other outcomes:
measure: Length of hospital stay
timeFrame: During hospitalization (up to 30 days)
measure: Number of In-hospital complications
timeFrame: During hospitalization (up to 30 days)
measure: Number of times insulin is administered
timeFrame: During hospitalization (up to 30 days)
measure: Insulin doses
timeFrame: During hospitalization (up to 30 days)
measure: Readmissions and mortality
timeFrame: 30-day after discharge from hospital
measure: Questionnaires
timeFrame: During hospitalization (up to 30 days)
Locations:
city: Herlev
country: Denmark
facility: Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen)
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital - North Zealand
Study officials:
affiliation: Copenhagen University Hospital - North Zealand, Department of Endocrinology and Nephrology, Denmark
name: Peter Lommer Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital - Herlev-Gentofte, Steno Diabetes Center Copenhagen, Denmark
name: Katrine Bagge Hansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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