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Fast-Acting Insulin Aspart and Insulin Pump Settings المرحلة الرابعة ٤٠

غير معروف
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT04620967 مصممة لدراسة علاج لـداء السكري من النوع 1. إنها دراسة تدخُّلية من المرحلة الرابعة وهي غير معروف. بدأت في ١٩ جمادى الآخرة ١٤٤٢ هـ مع خطة لتجنيد ٤٠ مشاركًا. تقودها Kirsten Nørgaard، ومن المتوقع اكتمالها بحلول ١ ذو الحجة ١٤٤٣ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٤ رجب ١٤٤٢ هـ.
الملخص

To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed.

The aim of this study is twofold:

  1. to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy.
  2. to determine differences in insulin pu...
عرض المزيد
العنوان الرسمي

Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY

الحالات الطبية
داء السكري من النوع 1
معرّفات دراسة أخرى
  • 2020-001158-23
  • H-20022359 (معرف آخر) (Scientific Ethical Committee of the Capital Region of Denmark)
NCT معرّف
NCT04620967
تاريخ البدء (فعلي)
2021-02-01
آخر تحديث مُنشور
2021-02-16
تاريخ الاكتمال (المقدر)
2022-06-30
عدد المشاركين المخطط لهم
٤٠
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الرابعة
الحالة
غير معروف
الكلمات الرئيسية
Insulin pump
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
تصميم متقاطع
التعمية
ثلاثي
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
تجريبيةIasp-Fiasp
First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp
Insulin aspart
Insulin aspart (Iasp) in insulin pump
Fast-acting insulin aspart
Fast-acting insulin aspart (Fiasp) in insulin pump
تجريبيةFiasp-Iasp
First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp
Insulin aspart
Insulin aspart (Iasp) in insulin pump
Fast-acting insulin aspart
Fast-acting insulin aspart (Fiasp) in insulin pump
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Time in range
Difference in time spent with glucose values in the range 3.9-10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Last two weeks of the 16-week interventions
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Mean glucose
Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Last two weeks of the 16-week interventions
Coefficient of variation
Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Last two weeks of the 16-week interventions
Time below range level 1
Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Last two weeks of the 16-week interventions
Time below range level 2
Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Last two weeks of the 16-week interventions
Time above range level 1
Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Last two weeks of the 16-week interventions
Time above range level 2
Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring
Last two weeks of the 16-week interventions
Fructosamine
Difference in change in fructosamine between Fiasp and Iasp treatment
16 weeks
Total daily insulin dose
Difference between Fiasp and Iasp treatment in total daily insulin dose
Last two weeks of the 16-week interventions
Total daily basal insulin dose
Difference between Fiasp and Iasp treatment in total daily basal insulin dose
Last two weeks of the 16-week interventions
Total daily bolus insulin dose
Difference between Fiasp and Iasp treatment in total daily bolus insulin dose
Last two weeks of the 16-week interventions
Severe hypoglycemia
Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events
16 weeks
Ketoacidosis
Difference between Fiasp and Iasp treatment in number of ketoacidosis events
16 weeks
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
  • Type 1 diabetes for ≥ 5 years
  • HbA1c 53-75 mmol/mol (7.0-9.0%)
  • Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)
  • CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)
  • Carbohydrate counting for all snacks and meals
  • Use of the insulin pump bolus calculator for all meals and snacks

  • Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods
  • Gastroparesis (clinical assessment)
  • Shift work
  • Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns
  • Use of a hybrid closed-loop system
  • Use of flash glucose monitoring
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
  • Chronic paracetamol use
  • Alcohol or drug abuse
  • Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol
  • Impaired renal function (eGFR< 60 ml/min/1.73 m2)
  • History of local skin reactions to Fiasp and/or Iasp
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
  • Lack of compliance with key study procedures at the discretion of the investigator
  • Unacceptable adverse events at the discretion of the investigator
  • Less than 40 weeks guarantee remaining on insulin pump
Kirsten Nørgaard logoKirsten Nørgaard
الجهة المسؤولة عن الدراسة
Kirsten Nørgaard, الراعي-المحقق, Senior Consultant, Steno Diabetes Center Copenhagen
جهة اتصال مركزية للدراسة
جهة اتصال: Signe Schmidt, MD PhD, +45 51174785, [email protected]
1 مواقع الدراسة في 1 بلدان
Steno Diabetes Center Copenhagen, Gentofte Municipality, 2820, Denmark
Signe Schmidt, MD PhD, جهة اتصال, +45 51174785, [email protected]
Ajenthen Ranjan, MD PhD, محقق فرعي
Hanne-Charlotte Andersen, RN, محقق فرعي
Signe Schmidt, MD PhD, محقق فرعي
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