Diabetes Mellitus, Type 2
Conditions
Keywords
Inpatient, Randomised controlled trial, Hyperglycemia, Hypoglycemia, Glycemic variabiity, Continuous glucose monitoring, CGM, In-hospital, Telemetric continuous glucose monitoring
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
Interventions
DEVICEDexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)
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.
DEVICEFreeStyle Precision Pro Glucometer for glucose POC testing
For the POC-arm subjects, glucose assessment is done by standard ward glucometer.
Sponsors
Peter Kristensen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an investigator-initiated, two-site, prospective randomised open-label blinded endpoint (PROBE) trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Coefficient of variation (CV) | During hospitalization (up to 30 days) | SD divided by mean glucose level |
| Mean glucose levels | During hospitalization (up to 30 days) | mmol/L (mg/dL) |
| Hypoglycemia < 3.9 mmol/L (< 70 mg/dL) | During hospitalization (up to 30 days) | mmol/L (mg/dL), duration ≥15 consecutive min. |
| 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. |
| 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). |
| 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). |
| 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) <3.0 (<54 mg/dL) | During hospitalization (up to 30 days) | Percentage of time below range; amount of time (hours and minutes) |
| Standard deviation (SD) of all CGM glucose levels | During hospitalization (up to 30 days) | mmol/L (mg/dL) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of times insulin is administered | During hospitalization (up to 30 days) | The number of times basal, prandial, and correctional insulin is used in total and correctly used according to clinical investigation plan specifications. |
| Insulin doses | During hospitalization (up to 30 days) | Basal, prandial, and correctional insulin doses in total. |
| Readmissions and mortality | 30-day after discharge from hospital | Assesment of 30-day numbers of readmissions and mortality. |
| Questionnaires | During hospitalization (up to 30 days) | Subject and in-hospital diabetes team user satisfaction levels with in-hospital telemetric CGM are assessed by validated questionnaires. |
| Number of In-hospital complications | During hospitalization (up to 30 days) | Any in-hospital related complications occurring at least one day after randomisation (e.g. acute kidney injury, death during hospitalisation, transfer to intensive care unit etc.). |
| Length of hospital stay | During hospitalization (up to 30 days) | The length of hospital stay from inclusion to discharge. |
Countries
Denmark
Outcome results
None listed