- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05163054
Cohort Study of Patients With Type 1 Diabetes Registered With Mobile Application in China (COOPERATIONS)
2022년 5월 31일 업데이트: Peking University Third Hospital
For last decade, the innovation of mobile health platform has brought new opportunities for disease management.
Previous studies have shown that health management programs based on mobile platforms for patients with diabetes can improve patients' glucose control, self-management ability and quality of life.
Type 1 diabetes mellitus (T1DM) due to its characteristics needs long-term linkage care throughout the lifespan cycle of patients.
Therefore, this study intends to construct a prospective and open T1DM cohort based on mobile application and platform, to deliver home-community-hospital joint management for patients, and to provide follow-up online or offline every 3 months lasting for 10 years.
Mainly, the objective of this study is to observe the blood glucose control outcome of T1DM patients.
Secondly, the control of comprehensive metabolic indicators such as blood pressure and blood lipid, occurrence and progression of acute and chronic complications, and psychosocial status were included as well, expecting to provide scientific evidence for continuously improving the quality of T1DM management.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
관찰
등록 (예상)
500
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kun Yang, MD
- 전화번호: 86-13651315864
- 이메일: yangkun@bjmu.edu.cn
연구 연락처 백업
- 이름: Jin Yang, PhD
- 전화번호: 86-15810298367
- 이메일: yangjin@bjmu.edu.cn
연구 장소
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Beijing, 중국, 100191
- Peking University Third Hospital
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연락하다:
- Kun Yang, MD
- 전화번호: 86-13651315864
- 이메일: yangkun@bjmu.edu.cn
-
연락하다:
- Jin Yang, PhD
- 전화번호: 86-15810298367
- 이메일: yangjin@bjmu.edu.cn
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Patients with type 1 diabetes from in-patient and out-patient.
설명
Inclusion Criteria:
- At least 12 years old;
- Diagnosed as type 1 diabetes according to World Health Organization (WHO) criteria in 1999;
- Be able to use smart mobile phones;
- Informed consent and voluntary participation.
Exclusion Criteria:
- Secondary diabetes;
- Complicated with malignant diseases, such as cancer, hepatic and renal failure;
- Complicated with cognitive impairment or mental illness;
- Be pregnant or lactating at the time of enrollment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
HbA1c
기간: Outcome evaluation at 10 years.
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HbA1c is one of the indicators that reflects the level of blood glucose control overall.
Blood sample will be required and tested.
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Outcome evaluation at 10 years.
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Time in range (TIR)
기간: Outcome evaluation at 10 years.
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TIR is one of the indicators that reflects the level of blood glucose control from the point of view of target time.
Continuous glucose monitoring (CGM) devices will be used.
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Outcome evaluation at 10 years.
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Incidence of hypoglycemia
기간: Outcome evaluation at 10 years.
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Incidence of hypoglycemia is one of the indicators that reflects the level of blood glucose control.
Hypoglycemia is defined as blood glucose lower than 3.9mmol/L with or without symptoms.
Incidence of hypoglycemia is occurence times per month according to patients self-reported.
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Outcome evaluation at 10 years.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Comprehensive metabolic control
기간: Outcome evaluation at 10 years.
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Blood pressure is one of the control level comprehensive metabolic indicators, including systolic blood pressure (SBP) and diastolic blood pressure (DBP).
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Outcome evaluation at 10 years.
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Comprehensive metabolic control
기간: Outcome evaluation at 10 years.
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Blood lipid is one of the control level of comprehensive metabolic indicators, including total cholesterol (TC), total triglyceride (TG), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C).
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Outcome evaluation at 10 years.
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Occurrence of Diabetes-related complications.
기간: Outcome evaluation at 10 years.
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To observe and analyze occurrence of diabetes-related acute and chronic complications.
Acute complications of diabetes include diabetic ketoacidosis (DKA), hypoglycemia and Hyperglycemic Hyperosmolar Syndrome (HHS).
Chronic complications of diabetes including retinopathy, neuropathy nephropathy and lower extremity amputations (LEA).
Other diabetes-related complications include cardiovascular disease, heart failure, stroke and death.
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Outcome evaluation at 10 years.
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Progression of Diabetes-related complications.
기간: Outcome evaluation at 10 years.
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To observe and analyze progression of diabetes-related acute and chronic complications.
Acute complications of diabetes include diabetic ketoacidosis (DKA), hypoglycemia and Hyperglycemic Hyperosmolar Syndrome (HHS).
Chronic complications of diabetes including retinopathy, neuropathy nephropathy and lower extremity amputations (LEA).
Other diabetes-related complications include cardiovascular disease, heart failure, stroke and death.
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Outcome evaluation at 10 years.
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Anxiety condition.
기간: Outcome evaluation at 10 years.
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Anxiety condition is one of the psychosocial status indicators, and Self-Rating Anxiety Scale (SAS) will be used to assess anxiety level.
The score ranges from 20 to 100, and higher score indicates more prone to anxiety.
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Outcome evaluation at 10 years.
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Anxiety condition.
기간: Outcome evaluation at 10 years.
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Anxiety condition is one of the psychosocial status indicators.
Generalized Anxiety Disorder 7-Item Scale (GAD-7 scale) will be used to assess anxiety symptoms.
The score ranges from 0 to 7, and higher score indicates more anxiety symptoms.
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Outcome evaluation at 10 years.
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Depression condition.
기간: Outcome evaluation at 10 years.
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Depression condition is one of the psychosocial status indicators, and Self-Rating Depression Scale (SDS) will be used to assess depression level.
The level of depression is measured by depression severity index.
The index ranges from 0.25 to 1.0, with higher scores associated with greater depression.
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Outcome evaluation at 10 years.
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Depression condition.
기간: Outcome evaluation at 10 years.
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Depression condition is one of the psychosocial status indicators, and Patient Health Questionnaire-9 (PHQ-9) will be used to assess depression level.
The score ranges from 0 to 27.
A higher score indicates a higher degree of depression.
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Outcome evaluation at 10 years.
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Depression condition.
기간: Outcome evaluation at 10 years.
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Depression condition is one of the psychosocial status indicators, and Problem Areas in Diabetes-Short form (PAID-5) will be used to evaluate the diabetes related emotional distress, which is strongly association with depression.
A score ≥40 indicates high diabetes-related distress.
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Outcome evaluation at 10 years.
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Life quality.
기간: Outcome evaluation at 10 years.
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Life quality is one of the psychosocial status indicators, and specific scales as World Health Organization-5 well-being index (WHO-5) will be used to assess this factor.
A score <50 indicates poor psychological well-being.
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Outcome evaluation at 10 years.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Jin Yang, PhD, Peking University Third Hospital
- 수석 연구원: Kun Yang, MD, Peking University Third Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (예상)
2022년 6월 1일
기본 완료 (예상)
2032년 1월 1일
연구 완료 (예상)
2032년 1월 1일
연구 등록 날짜
최초 제출
2021년 11월 9일
QC 기준을 충족하는 최초 제출
2021년 12월 6일
처음 게시됨 (실제)
2021년 12월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 6월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 5월 31일
마지막으로 확인됨
2021년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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