رادار التجارب AI | ||
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حالة التجربة السريرية NCT03445377 (MILLENNIALS) لـ داء السكري النوع 1 هي مكتمل. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Comparison of Real-tiMe ContInuous gLucosE moNitoriNg With Self-monitorIng of Blood Glucose in Young AduLts With Type 1 diabeteS (MILLENNIALS) ٣٢
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 NCT03445377 (MILLENNIALS) كانت دراسة تدخُّلية لـداء السكري النوع 1 وهي الآن مكتمل. بدأت في ٣ ذو القعدة ١٤٣٩ هـ مع خطة لتجنيد ٣٢ مشاركًا. بقيادة Manchester University NHS Foundation Trust، وكان من المتوقع اكتمالها في ٧ ذو القعدة ١٤٤١ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٣ شعبان ١٤٤٢ هـ.
الملخص
The main objective of this study is to determine whether real-time continuous glucose monitoring (CGM) for 8 weeks is more efficacious compared to self-monitoring of blood glucose (SMBG) in young adults with type 1 diabetes.
وصف مفصل
This is an open-label, multi-centre, randomised, crossover design study, involving a 2-week run-in period with blinded CGM, followed by two 8 weeks study periods during which subjects will monitor daily glucose levels either with real-time CGM or SMBG in random order. Subjects will wear a blinded CGM for a 3-week period during the Control phase. A total of up to 40 subjects (aiming for 30 completed subjects) aged 16 ...عرض المزيد
العنوان الرسمي
An Open-label, Single-centre, Randomised, Cross-over Design Feasibility Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Comparison With Self-monitoring of Blood Glucose in Young Adults and Adolescents With Type 1 Diabetes
الحالات الطبية
داء السكري النوع 1المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- MILLENNIALS
- R04778
NCT معرّف
تاريخ البدء (فعلي)
2018-07-16
آخر تحديث مُنشور
2021-03-16
تاريخ الاكتمال (المقدر)
2020-06-28
عدد المشاركين المخطط لهم
٣٢
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
مكتمل
الغرض الأساسي
أخرى
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
تصميم متقاطع
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
مقارن نشطReal-time continuous glucose monitoring Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. Training on the use of DEXCOM G5 or similar will be provided by the research team. Competency on the use of the system will be evaluated. Participants will be advised to use real-time CGM continuously for the next 8 weeks. At the end of the first intervention, a blood sample for the measurement of HbA1c will be taken. Validated q...عرض المزيد | Real-time continuous glucose monitoring Subjects randomised to Real-time continuous glucose monitoring will be given a Dexcom G5 or similar, training on its use, and HbA1c measurements taken at the start and end of the study. They will also be given validated questionnaires to complete. |
مقارن بالدواء الوهميSelf-monitoring of blood glucose Subjects will be reviewed and a blood sample will be taken for the measurement of HbA1c. During the Control Period, masked CGM will be applied for one week, during Week 1, 4 and 8. At the end of this, a blood sample for the measurement of HbA1c will be taken. Validated questionnaires evaluating diabetes-related distress, management and user acceptance will be completed. | Self-monitoring of blood glucose Subjects randomised to self monitoring of blood glucose will be given a masked CGM which will be applied for one week, during Week 1, 4 and 8. HbA1c measurements will be taken at the start and end of the study. They will also be given validated questionnaires to complete. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Sensor Glucose readings within target range | Time spent in the target range of 3.9 to 10mmol/l based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Sensor Glucose readings below target range | Time spent with glucose levels below 3.9 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks |
Sensor Glucose readings above target range | Time spent with glucose levels above 10.0 mmol/L based on sensor glucose levels, throughout the duration of the study periods based on continuous glucose monitoring (CGM). | 8 weeks |
HbA1c at 8 weeks | HbA1c at 8 weeks (midway point) | 8 weeks |
Average variation of glucose levels | Average variation of glucose levels | 8 weeks |
Standard deviation variation of glucose levels | Standard deviation variation of glucose levels | 8 weeks |
Coefficient variation of glucose levels | Coefficient variation of glucose levels | 8 weeks |
The time with sensor glucose levels < 3.5 mmol/l , 3.0 and <2.8 mmol/l | The time with sensor glucose levels \< 3.5 mmol/l , 3.0 and \<2.8 mmol/l | 8 weeks |
The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) | The time with glucose levels in the significant hyperglycaemia (glucose levels \> 16.7 mmol/l) | 8 weeks |
AUC of glucose below 3.5mmol/l | AUC (Area under the Curve) of glucose below 3.5mmol/l | 8 weeks |
Total daily insulin dose | Total, basal and bolus insulin dose | 8 weeks |
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل, بالغ
العمر الأدنى للدراسة
16 Years
الجنس المؤهل
الكل
- Age between 16 - 24 years old (inclusive)
- Type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
- HbA1c 7.5 - 14.0% based on analysis from local laboratory or equivalent within 1 months of enrolment
- Treated with insulin pump or MDI
- Has a Smart phone compatible with Dexcom G5 or similar
- Willingness to wear study devices
- Willing to follow study specific instructions
- Literate in English
- Non-type 1 diabetes mellitus including those secondary to chronic disease
- Any other physical or psychological disease likely to interfere with the normal conduct of the study
- Untreated celiac disease or hypothyroidism
- Current or planned users of real-time or flash (Libre) glucose monitoring sensors
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers and MAO inhibitors etc.
- Regular use of acetaminophen
- Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
- Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which could potentially be used for localisation of the glucose sensor)
- Lack of reliable telephone facility for contact
- Known or suspected allergy against insulin
- Severe visual impairment
- Severe hearing impairment
- Subject not proficient in English
Manchester University NHS Foundation TrustDexCom, Inc.لا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
Manchester Diabetes Centre, Manchester University NHS Foundation Trust, Manchester, M13 9WL, United Kingdom