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رادار التجارب AI
دراسة واحدة تطابق معايير الفلتر
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Hypoglycaemia (Low Blood Sugar) in Adults With Diabetes and Adrenal Failure (HYPO-DIAD) ٣٢ جهاز قابل للارتداء نظام غذائي

مكتمل
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 NCT05806190 (HYPO-DIAD) كانت دراسة رصدية لـداء السكري النوع 1، قصور الغدة الكظرية، Diabetes Mellitus Type 2 - Insulin-Treated وهي الآن مكتمل. بدأت في ٢٦ رمضان ١٤٤٤ هـ مع خطة لتجنيد ٣٢ مشاركًا. بقيادة Imperial College Healthcare NHS Trust، وكان من المتوقع اكتمالها في ٣٠ صفر ١٤٤٥ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٣ ربيع الأول ١٤٤٥ هـ.
الملخص
The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone.

Low blood sugar (hypoglycemia) is a very common side effect o...

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وصف مفصل
PURPOSE OF THE STUDY

The purpose of this study is to measure how often hypoglycaemia occurs in people who take steroid tablets for adrenal insufficiency and insulin for diabetes compared to individuals with adrenal insufficiency on steroid tablets without diabetes. To do this, participants will be given a continuous glucose monitoring (CGM) system, which is an effective and accurate way of measuring blood sugars thr...

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العنوان الرسمي

Frequency of Nocturnal Hypoglycaemia in Adults With Insulin-treated Diabetes and Adrenal Failure Using Prednisolone or Hydrocortisone: a Pilot Study

الحالات الطبية
داء السكري النوع 1قصور الغدة الكظريةDiabetes Mellitus Type 2 - Insulin-Treated
المنشورات
مقالات علمية وأوراق بحثية منشورة حول هذه التجربة السريرية:
معرّفات دراسة أخرى
  • HYPO-DIAD
  • 22SM8022
NCT معرّف
NCT05806190
تاريخ البدء (فعلي)
2023-04-17
آخر تحديث مُنشور
2023-09-28
تاريخ الاكتمال (المقدر)
2023-09-15
عدد المشاركين المخطط لهم
٣٢
نوع الدراسة
رصدية
الحالة
مكتمل
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
Study group
Participants who live with insulin- treated diabetes and adrenal insufficiency.
مراقبة الجلوكوز المستمرة
Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device
Control group
Participants who live with adrenal insufficiency and NOT with insulin-treated diabetes.
مراقبة الجلوكوز المستمرة
Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
Time spent in hypoglycaemia
Percentage time spent in hypoglycaemia (glucose levels \< 3.0mmol/L, 55mg/dL). Glucose levels will be measured by a continuous glucose monitoring device (CGM).
30 days
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
Time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)
Percentage time spent in hypoglycaemia (glucose levels \< 3.9mmol/L, 70mg/dL)
30 days
Time spent in target glucose levels
Percentage time spent in target (glucose levels 3.9-10mmol/L, 70-180mg/dL)
30 days
Time spent in hyperglycaemia
Percentage time spent in hyperglycaemia (glucose levels \>10mmol/L, 180mg/dL)
30 days
Hypoglycaemic excursions
Number of hyperglycaemic excursions. This will comprise the number of times glucose sugar levels are recorded as below 3.9mmol/L, 70mg/dL
30 days
Gold questionnaire score
The Gold questionnaire asks individuals to report their experience in detecting hypoglycemic events with scores ranging from minimum score of 1 (always aware) to a maximum score of 7 (never aware). The minimum score refers to the individual never being aware of hypoglycaemia, and an increasing score refers to greater awareness of hypoglycaemia.
Baseline
Hypoglycaemia Fear Survey-II (HFS-II) score
This 33-item questionnaire assesses fear of hypoglycaemia. The minimum score is 0 and the maximum score is 132. A higher score indicated greater fear of hypoglycaemia.
Baseline
Hospital Anxiety and Depression (HADS) Score
A questionnaire assessing levels of anxiety and depression. The questionnaire consists of 14 questions: 7 questions assess for anxiety and 7 questions assess for depression. Each question can score between 0 and 3. Two scores are calculated separately for anxiety and depression. The minimum score is 0 and maximum score is 21 for both anxiety and depression. A greater score denotes greater severity of anxiety or depression.
Baseline
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل

for test group:

  • Confirmed diagnoses of adrenal insufficiency and insulin-treated diabetes for more than one year.
  • Adults aged above 18 years

for matched control group:

  • Diabetes mellitus excluded on baseline blood review
  • Adults aged above 18 years

  • Measured eGFR ≤ 30
  • Acute illness
  • Abnormal thyroid function
  • Admission to hospital
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials, except at the discretion of the chief investigator
  • Have active malignancy or under investigation for malignancy
  • Severe visual impairment
  • Reduced manual dexterity
  • Unable to participate due to other factors, as assessed by the Chief Investigators
Imperial College Healthcare NHS Trust logoImperial College Healthcare NHS Trust
لا توجد بيانات اتصال.
1 مواقع الدراسة في 1 بلدان
Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, w6 8rf, United Kingdom