임상 레이더 AI | ||
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임상시험 NCT06453434 (DIASELF)은(는) 제1형 당뇨병에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Diabetes Self-management With Continuous Glucose Monitoring (DIASELF) 500 관찰 연구
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06453434 (DIASELF)은(는) 제1형 당뇨병에 대해 알아보는 관찰연구입니다. 현재 상태는 대상자모집전이며, 2024년 7월 1일부터 참여 신청이 가능합니다. 500명의 참여자를 모집할 예정입니다. Nordsjaellands Hospital이(가) 진행하는 이 연구는 2026년 8월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 6월 11일에 갱신되었습니다.
간단한 개요
The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (CGM) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics.
Participants will:
- Visit the clinic twice with a 14-day interval
- Fill out a survey before the first and at the last visit
- Use CGM as u...
상세한 설명
A two-centre observational study conducted in Denmark, including adults with type 1 diabetes (n=500) on multiple daily injections already using FreeStyle Libre 2.
Upon recruitment, participants will complete a survey of 11 validated questionnaires, including T1-DDS-28. For 14 days, participants will continue regular CGM use, smart insulin pens will record real-time insulin dosage, and an activity sensor will monitor...
더 보기공식 제목
The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes
질환명
제1형 당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- DIASELF
- U1111-1306-6133
NCT 번호
실제 연구 시작일
2024-07-01
최신 업데이트 게시
2024-06-11
예상 연구 완료일
2026-08
계획된 등록 인원
500
연구종류
관찰연구
상태
대상자모집전
키워드
Continuous Glucose Monitoring
Self-management
Diabetes Technology
Type 1 Diabetes
Diabetes Distress
Patient-reported Outcomes
Self-management
Diabetes Technology
Type 1 Diabetes
Diabetes Distress
Patient-reported Outcomes
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Diabetes Distress | Type 1 Diabetes Distress Scale (T1-DDS-28)) Score. Likert scale. Score from 1 to 5. Higher scores indicate higher grade of diabetes distress. | At baseline and after 14 days. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time in range (TIR) | Time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL) | 14 days |
Time in tight range (TIR) | The percentage of time the sensor glucose is 3.9-7.8 mmol/L (70-140 mg/dL) | 14 days |
Time below range level 1 (TBR1) | The percentage of time the sensor glucose is 3.0-3.9 mmol/L (54-70 mg/dL) | 14 days |
Time below range level 2 (TBR2) | The percentage of time the sensor glucose is \<3.0 mmol/L (\<54 mg/dL) | 14 days |
TBR1 night | TBR 3.0-3.9 from 0000h to 0559h, level 1 night | 14 days |
TBR1 day | TBR 3.0-3.9 from 0600h to 2359h, level 1 day | 14 days |
TBR2 night | TBR \<3.0 from 0000h to 0559h, level 2 night | 14 days |
TBR2 day | TBR \<3.0 from 0600h to 2359h, level 2 day | 14 days |
Time above range level 1 (TAR1) | The percentage of time the sensor glucose is 10.1-13.9 mmol/L (181-250 mg/dL) | 14 days |
Time above range level 2 (TAR2) | The percentage of time the sensor glucose is 13.9 mmol/L (\>250 mg/dL) | 14 days |
TAR1 night | TAR1 10.1-13.9 from 0000h to 0559h, level 1 night | 14 days |
TAR1 day | TAR1 10.1-13.9 from 0600h to 2359h, level 1 day | 14 days |
TAR2 night | TAR2 \>13.9 from 0000h to 0559h, level 1 night | 14 days |
TAR2 day | TAR2 \>13.9 from 0600h to 2359h, level 1 day | 14 days |
Coefficient of variation (CV) | Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose) | 14 days |
Mean sensor glucose | Mean sensor glucose (mmol/L and mg/dL) | 14 days |
Standard deviation of mean glucose (SD) | Standard deviation of mean glucose (SD) (mmol/L and mg/dL) | 14 days |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Age between 18 and 85 years.
- Diagnosed with T1D over one year ago.
- Actively using FreeStyle Libre 2 (>80% sensor activity).
- Used FreeStyle Libre 2 for over three months.
- Uses multiple daily insulin injections.
- Capable of providing written informed consent.
- Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.
- History of allergic reactions to materials or adhesives used in CGM devices.
- Presence of severe cognitive or psychiatric conditions that could hinder the effective use of CGM or smart caps or pens - at the investigator's discretion.
- Current use of steroids unless part of a chronic therapy plan.
- Daily consumption of vitamin C ≥ 500 mg.
Nordsjaellands HospitalSteno Diabetes Center Copenhagen연구 대표 연락처
연락처: Mette J Nitschke, PhD Student, +45 41 24 72 16, [email protected]
연락처: Ulrik Pedersen-Bjergaard, Professor, [email protected]
2 1개국에 임상시험 장소
Capital Region
Steno Diabetes Center Copenhagen, Herlev, Capital Region, 2730, Denmark
Kirsten Nørgaard, Professor, 연락처, +45 27 13 10 11, [email protected]
Kirsten Nørgaard, Professor, 책임연구자
Copenhagen University Hospital, North Zealand - Hilleroed, Hillerød, Capital Region, 3400, Denmark
Mette J Nitschke, PhD student, 연락처, +45 41 24 72 16, [email protected]
Mette J Nitschke, PhD student, 공동연구자
Ulrik Pedersen-Bjergaard, Professor, 책임연구자