رادار التجارب AI | ||
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حالة التجربة السريرية NCT05944718 (ACCEDE) لـ داء السكري من 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
Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa (ACCEDE) ٢٤٦
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 NCT05944718 (ACCEDE) كانت دراسة تدخُّلية لـداء السكري من النوع 1 وهي الآن مكتمل. بدأت في ٢٦ صفر ١٤٤٥ هـ مع خطة لتجنيد ٢٤٦ مشاركًا. بقيادة Foundation for Innovative New Diagnostics, Switzerland، وكان من المتوقع اكتمالها في ٦ صفر ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٨ صفر ١٤٤٧ هـ.
الملخص
Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monit...عرض المزيد
وصف مفصل
3 Study Design As this study is a PrCT the study aspects will be embedded in the normal clinical care delivery of diabetes care in the selected clinics (see section 3.2, Scientific Rational for Selection of Study Design). Introducing only 1 additional clinic visit and 1 additional qualitative visit for study related procedures. The primary outcome measure, HbA1c, will be assessed through the HbA1c testing that is alr...عرض المزيد
العنوان الرسمي
Three-arm Pragmatic Randomized Study on the Effectiveness, Feasibility, Acceptability, and Cost of the Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa
الحالات الطبية
داء السكري من النوع 1المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:معرّفات دراسة أخرى
- ACCEDE
- NC008
NCT معرّف
تاريخ البدء (فعلي)
2023-09-11
آخر تحديث مُنشور
2025-08-12
تاريخ الاكتمال (المقدر)
2025-07-31
عدد المشاركين المخطط لهم
٢٤٦
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
مكتمل
الكلمات الرئيسية
continuous glucose monitoring
الغرض الأساسي
تشخيصي
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
لا شيء (تجربة مفتوحة)
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةArm 1 Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months. | مراقبة الجلوكوز المستمرة Continuous Glucose Monitoring (CGM) is a technology used to measure glucose levels in people with diabetes. Unlike traditional finger prick self-monitoring of blood glucose (SMBG), CGM devices provide continuous and real-time glucose readings throughout the day and night.
CGM systems consist of a small sensor that is inserted under the skin to measure glucose levels in the interstitial fluid, a transmitter that send...عرض المزيد |
تجريبيةArm 2 Arm 2 is those participants randomized to intermittent use of CGM; CGM use for 4 time points consisting of 2 weeks of CGM use each, for the duration of 9 months. | مراقبة الجلوكوز المستمرة Continuous Glucose Monitoring (CGM) is a technology used to measure glucose levels in people with diabetes. Unlike traditional finger prick self-monitoring of blood glucose (SMBG), CGM devices provide continuous and real-time glucose readings throughout the day and night.
CGM systems consist of a small sensor that is inserted under the skin to measure glucose levels in the interstitial fluid, a transmitter that send...عرض المزيد |
بدون تدخلArm 3 Arm 3 is those participants randomized to standard of care; regular use of self-monitoring of blood glucose (SMBG) for the duration of 9 months. | غ/م |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Impact of continuous and intermittent CGM use on blood glucose levels in comparison to standard of care in people living with type 1 diabetes | Comparison of the magnitude of change in HbA1c levels before and after treatment in standard of care, continuous, and intermittent CGM arms | 15 months |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
1a. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. | Estimates of coefficient of variation (CV) for glucose concentrations with 95% confidence intervals, for participants who received the CGM treatments. | 15 months |
1b. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. | Estimates Time in Range (TIR) with 95% confidence intervals for participants who received the CGM treatments. | 15 months |
1c.Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. | Estimates Time Below Range (TBR) with 95% confidence intervals for participants who received the CGM treatments. | 15 months |
1d. Impact of continuous and intermittent CGM use on the variability of blood glucose concentrations related to diabetes. | Estimates Time Above Range (TAR) with 95% confidence intervals for participants who received the CGM treatments. | 15 months |
2. Impact of continuous and intermittent CGM use on unplanned visits to outpatient clinics and/or hospital related to diabetes complications. | Number of hospitalizations related to diabetes complications per each group, represented by means and standard deviations. | 15 months |
3a. Impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable) | Mixed methods QoL A: survey results including EQ-5D-Y/EQ-5D and Diabetes distress scores at baseline, midpoint, end point of intervention and endpoint of study. | 15 months |
3b. Impact of continuous and intermittent CGM use on quality of life of recipients of diabetes care and their caregivers (where applicable) | Mixed methods : Qualitative methods FGD among recipients of care and their caregivers | 15 months |
4a. Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. | Mixed methods: Feasibility will be assessed based on Arm 1 and Arm 2 adherence to protocol in terms of CGM use. | 15 months |
4b.Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. | survey from baseline, midline, and endline among recipients of care and their caregivers. | 15 months |
4c. Acceptability and feasibility of continuous and intermittent CGM use from a healthcare provider, recipients of care and care givers perspective. | Mixed methods: Qualitative methods: SSI among health care providers involved in clinical care at the study sites. | 15 months |
5. Cost of continuous and intermittent CGM use from a user and provider perspective | Costing surveys which capture direct and indirect costs at each follow-up visit among recipients of care, their caregivers and healthcare provider, and at end point of study, modelling over time horizon may be explored. | 15 months |
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل, بالغ, كبار السن
العمر الأدنى للدراسة
4 Years
الجنس المؤهل
الكل
يقبل المتطوعين الأصحاء
نعم
- Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply:
People living with T1 diabetes with HbA1c current levels ≥10% within the last 3 months (and at least 2 HbA1c ≥10% within the last 18 months prior to study enrolment) who are attending for diabetes care at the 3 study clinics.
Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study only if all the following inclusion criteria apply:
• The child/adolescent that the person is a care giver to is enrolled in the study.
Healthcare providers are eligible to be included in the study only if all the following inclusion criteria apply:
- Healthcare provider at the study sties engaged in diabetes care provision related to the study.
Participants are excluded from the Study if any of the following exclusion criteria apply:
- People living with T1 diabetes under 4 years old as this the minimum age for use of CGM as per the CGMs used in this study manufacturer instructions.
- People diagnosed with T1 diabetes within the last 2 years.
- People who have used a CGM in the last 6 months prior to enrollment.
- People who anticipate that they would have access to a CGM through means outside this study during the duration of the study (15 months).
- People living with Type 2 diabetes.
- Known pregnancy at the time of study enrolment.
- People who are not willing to agree to Freestyle Libre T&Cs
Foundation for Innovative New Diagnostics, Switzerlandلا توجد بيانات اتصال.
3 مواقع الدراسة في 1 بلدان
Gauteng
Steve Biko Academic Hospital, Pretoria, Gauteng, 0007, South Africa
Western Cape
Groote Schuur Hospital - Diabetes Centre, Cape Town, Western Cape, South Africa
Red Cross Hospital, Cape Town, Western Cape, South Africa