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Completed

NCT Number: NCT05803473

DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA)

Device

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".

FreeStyle Precision Pro Glucometer for glucose POC testing

Device

For the POC-arm subjects, glucose assessment is done by standard ward glucometer.

Primary outcomes

  1. Time in range

    Time frame: 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 outcomes

  1. Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL)

    Time frame: During hospitalization (up to 30 days)

    Percentage of time in range assessed each day of inclusion; amount of time (hours and minutes).

  2. Time above range (TAR) >10.0 mmol/L (>180 mg/dL)

    Time frame: During hospitalization (up to 30 days)

    Percentage of time above range; amount of time (hours and minutes).

  3. Time above range (TAR) >13.9 mmol/L (>250 mg/dL)

    Time frame: During hospitalization (up to 30 days)

    Percentage of time above range; amount of time (hours and minutes).

  4. Time below range (TBR) <3.9 mmol/L (<70 mg/dL)

    Time frame: During hospitalization (up to 30 days)

    Percentage of time below range; amount of time (hours and minutes)

  5. Time below range (TBR) <3.0 (<54 mg/dL)

    Time frame: During hospitalization (up to 30 days)

    Percentage of time below range; amount of time (hours and minutes)

  6. Standard deviation (SD) of all CGM glucose levels

    Time frame: During hospitalization (up to 30 days)

    mmol/L (mg/dL)

  7. Coefficient of variation (CV)

    Time frame: During hospitalization (up to 30 days)

    SD divided by mean glucose level

  8. Mean glucose levels

    Time frame: During hospitalization (up to 30 days)

    mmol/L (mg/dL)

  9. Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)

    Time frame: During hospitalization (up to 30 days)

    mmol/L (mg/dL), duration ≥15 consecutive min.

  10. Hypoglycemia (level 1) 3.0-3.8 mmol/L (54-69 mg/dL)

    Time frame: During hospitalization (up to 30 days)

    mmol/L (mg/dL), duration ≥15 consecutive min.

  11. Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)

    Time frame: During hospitalization (up to 30 days)

    mmol/L (mg/dL), duration ≥15 consecutive min.

  12. Recurrent hypoglycemic events

    Time frame: During hospitalization (up to 30 days)

    Number; Reoccurring hypoglycemic events after the first episode of hypoglycemia.

Other outcomes

  1. Length of hospital stay

    Time frame: During hospitalization (up to 30 days)

    The length of hospital stay from inclusion to discharge.

  2. Number of In-hospital complications

    Time frame: 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.).

  3. Number of times insulin is administered

    Time frame: 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.

  4. Insulin doses

    Time frame: During hospitalization (up to 30 days)

    Basal, prandial, and correctional insulin doses in total.

  5. Readmissions and mortality

    Time frame: 30-day after discharge from hospital

    Assesment of 30-day numbers of readmissions and mortality.

  6. Questionnaires

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peter Kristensen

Other

Registry information

Official study title

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

Acronym: DIATEC

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 7, 2023
Registry last updated
Feb 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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