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חזרה לחיפוש

DIAbetes TEam and Cgm in Managing Hospitalised Patients with Diabetes (DIATEC) 166

הושלם
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT05803473 (DIATEC) היה מחקר מסוג התערבותי עבור סוכרת סוג 2, שכעת הושלם. המחקר התחיל ב-11 באפריל 2023 ותוכנן לכלול 166 משתתפים. המחקר נוהל על ידי Peter Kristensen ותאריך הסיום היה 29 ביולי 2024. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-26 בפברואר 2025.
סיכום קצר
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.
תיאור מפורט
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 hosp...הצג עוד
כותרת רשמית

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

מצבים רפואיים
סוכרת סוג 2
פרסומים
מאמרים מדעיים וניירות מחקר שפורסמו על ניסוי קליני זה:
מזהי מחקר נוספים
  • DIATEC
  • 2301240
מספר NCT
NCT05803473
תחילת המחקר (בפועל)
2023-04-11
עדכון אחרון שפורסם
2025-02-26
סיום המחקר (מוערך)
2024-07-29
משתתפים (מתוכנן)
166
סוג המחקר
התערבותי
שלב
לא ישים
סטטוס
הושלם
מילות מפתח
Inpatient
Randomised controlled trial
Hyperglycemia
Hypoglycemia
Glycemic variabiity
Continuous glucose monitoring
CGM
In-hospital
Telemetric continuous glucose monitoring
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
אין (מחקר פתוח)
זרועות / התערבויות
קבוצת משתתפים/זרועהתערבות/טיפול
משווה פעילPOC-arm
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.
FreeStyle Precision Pro Glucometer for glucose POC testing
For the POC-arm subjects, glucose assessment is done by standard ward glucometer.
ניסיCGM-arm
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.
Dexcom 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".
מדדי תוצאה ראשיים
מדד תוצאהתיאור המדידהטווח זמן
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)
מדדי תוצאה משניים
מדד תוצאהתיאור המדידהטווח זמן
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)
קריטריוני זכאות

גילאים מוערכים למחקר
מבוגר, גיל שלישי
גיל מינימלי למחקר
18 Years
מגדרים מוערכים למחקר
הכל
  • 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).

  • 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.
Peter Kristensen logoPeter Kristensen
הגורם האחראי למחקר
Peter Kristensen, חוקר נותן החסות, Medical Doctor, PhD, Clinical Associate Professor, Nordsjaellands Hospital
אין נתוני קשר.
2 מיקומי המחקר ב-1 מדינות
Copenhagen University Hospital - Herlev-Gentofte (Steno Diabetes Center Copenhagen), Herlev, 2730, Denmark
Copenhagen University Hospital - North Zealand, Hillerød, 3400, Denmark