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임상시험 NCT04328896 (TELE-MONITOR)은(는) 제1형 당뇨병, 저혈당증에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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서던캘리포니아 대학교Telemedicine Monitoring of Nocturnal Incidents (TELE-MONITOR) 10 원격 참여
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 NCT04328896 (TELE-MONITOR)은(는) 제1형 당뇨병, 저혈당증에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2018년 6월 15일에 시작되어 10명의 참여자와 함께 진행되었습니다. 서던캘리포니아 대학교이(가) 진행한 이 연구는 2018년 11월 30일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2020년 4월 1일에 갱신되었습니다.
간단한 개요
Reducing hypoglycemia is an important aspect of management of type 1 diabetes (T1D) in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. Continuous Glucose Monitoring (CGM) offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve QOL including reducing hypoglycemic fear and diabetes distress. The po...더 보기
상세한 설명
SUMMARY OF STUDY RATIONAL - Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve QOL including reducing hypoglycemic fear and diabetes distress. Despite these potential bene...더 보기
공식 제목
Telemedicine Monitoring of Nocturnal Incidents of Treatment-Requiring Hypoglycemia in Older Adults With Type 1 Diabetes Miletus - A Feasibility Study
질환명
제1형 당뇨병저혈당증기타 연구 식별자
- TELE-MONITOR
NCT 번호
실제 연구 시작일
2018-06-15
최신 업데이트 게시
2020-04-01
예상 연구 완료일
2018-11-30
계획된 등록 인원
10
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
Remote Daily Monitoring
Continuous Glucose Monitoring
Tele-Medicine
Continuous Glucose Monitoring
Tele-Medicine
주요 목적
기타
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Intervention Tele-CGM-monitoring: Subjects are remotely monitored daily through a continuous glucose monitoring (CGM) system (Dexcom G5/6) that communicates via smart phone to a Tidepool designed dashboard. Alerts set for: ≥4 hours without CGM signal, ≥2 hours 54-70 mg/dl, and 15 minutes \<54 mg/dl. Tidepool dashboard automatically emails daily alerts to the Certified Diabetes Educator (CDE). If alerts occurred, the CDE performed...더 보기 | CGM-Tele-monitoring Baseline Visit-Visit 0
1. Obtain informed consent
2. Administer questionnaires
3. Measure A1C
4. Start study Dexcom CGM device (those already on CGM will change to the study device).
5. The patient will be signed into Tidepool using a research code name and email.
Visit 1-2 weeks
1. 14 days worth of data will be downloaded from the patient's CGM device.
2. Systems will be checked to be sure they are functioning
3....더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
CGM-Tele-monitoring effects on hypoglycemia | Number of patients with lower incidents of hypoglycemia as assessed by CGM data and self report from baseline to 14 weeks. | 14 weeks |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
CGM-Tele-monitoring effects on CGM adherence | Number of patients with increased CGM use as assessed by number of days CGM data is available for download from baseline to 14 weeks. | 14 weeks |
CGM-Tele-monitoring effects on hypoglycemic fear | Number of patients with decreased hypoglycemic fear as measured by reduction in the hypoglycemic fear scale from baseline data to 14 weeks | 14 weeks |
CGM-Tele-monitoring effects on diabetes distress | Number of patients with decreased diabetes distress as measured by reduction in the diabetes distress scale from baseline data to 14 weeks. | 14 weeks |
CGM - Tele-monitoring effects on diabetes knowledge | Number of patients with increased diabetes knowledge as measured by an increase on the simplified diabetes knowledge test from baseline to 14 weeks. | 14 weeks |
CGM - Tele-monitoring effects on diabetic ketoacidosis | Number of patients with decreased incidents of diabetic ketoacidosis as measured by self-report from baseline to 14 weeks. | 14 weeks |
CGM - Tele-monitoring effects on HbA1c | Number of patients with decreased HbA1c as measured by point of care HbA1c level from baseline to 14 weeks. | 14 weeks |
적격성 기준
연령대
노인
최소 연령
65 Years
참여 가능한 성별
전체
- Diagnosis of type 1 diabetes
- Age >65 years old
- Insulin regimen involves either use of an insulin pump or multiple daily injections of insulin.
- Understand the study requirements and agree to comply with all study visits and procedures, including the use of the study CGM.
- Fluent in English or Spanish
- Must have a smart phone
1) No serious illnesses where life expectancy is <1 year
-
서던캘리포니아 대학교224개의 진행 중인 임상시험 탐색 가능연구 책임자
Anne Peters, 책임연구자, Professor of Clinical Medicine, University of Southern California
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
California
USC Westside Center for Diabetes, Los Angeles, California, 90211, United States