DIAbetes TEam and Cgm in Managing Hospitalised Patients With Diabetes

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)
* Device: FreeStyle Precision Pro Glucometer for glucose POC testing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is an investigator-initiated, two-site, prospective randomised open-label blinded endpoint (PROBE) trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: POC-arm<br>Subjects are monitored by point-of-care (POC) glucose testing. Diabetes management is done by usual ward nurses and guided by an in-hospital diabetes team. A blinded CGM is mounted in the POC-arm for outcome analysis. | Device: FreeStyle Precision Pro Glucometer for glucose POC testing<br>* For the POC-arm subjects, glucose assessment is done by standard ward glucometer.<br>|
| Experimental: CGM-arm<br>CGM-arm subjects are monitored by CGM viewed by the in-hospital diabetes team in addition to POC glucose testing performed by usual ward nurses. Diabetes management is done by usual ward nurses by POC glucose testing and guided by an in-hospital diabetes team with acces to CGM data. | Device: Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)<br>* For CGM-arm subjects, glucose data are obtained by the CGM Dexcom G6 which via an iPhone SE 3 transmits data to the in-hospital diabetes team stations to be displayed on an iPad 9 10.2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in range | 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. | During hospitalization (up to 30 days) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM, Inpatient, Randomised controlled trial, Hyperglycemia, Hypoglycemia, Glycemic variabiity, Continuous glucose monitoring, In-hospital, Telemetric continuous glucose monitoring