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임상시험 NCT05161793 (TELEMTRRDM)은(는) 제1형 당뇨병, 제2형 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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서던캘리포니아 대학교Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus (TELEMTRRDM) 200 관찰 연구 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 NCT05161793 (TELEMTRRDM)은(는) 제1형 당뇨병, 제2형 당뇨병에 대해 알아본 관찰연구입니다. 현재 상태는 완료입니다. 연구는 2022년 5월 1일에 시작되어 200명의 참여자와 함께 진행되었습니다. 서던캘리포니아 대학교이(가) 진행한 이 연구는 2025년 5월 31일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 7월 3일에 갱신되었습니다.
간단한 개요
The purpose of this single center observational study is to determine the effect of continuous remote continuous glucose monitor (CGM) reporting coupled with a telemedicine intervention (Tele-CGM program) on levels of HbA1C in adults with poorly controlled type 1 or type 2 diabetes. The investigators will follow 200 English and Spanish speaking adults (125 type 2 and 75 type 1 patients) who have an HbA1C >8% over 12...더 보기
상세한 설명
SUMMARY OF STUDY RATIONAL - Our project focuses on two populations; those with type 1 diabetes (T1D) and those with poorly controlled type 2 diabetes (T2D). Telemedicine Monitoring of Adults with Uncontrolled Diabetes Mellitus (Tele-MONITOR DM) is designed to reduce health care disparities in under resourced populations by enhancing existing telehealth visits for individuals with poorly controlled diabetes through co...더 보기
공식 제목
Telemedicine Continuous Remote Monitoring of Adults With Uncontrolled Diabetes Mellitus
질환명
제1형 당뇨병제2형 당뇨병기타 연구 식별자
- TELEMTRRDM
- TELE-MONITOR DM
NCT 번호
실제 연구 시작일
2022-05-01
최신 업데이트 게시
2025-07-03
예상 연구 완료일
2025-05-31
계획된 등록 인원
200
연구종류
관찰연구
상태
완료
키워드
Continuous Glucose Monitoring
Remote Monitoring
Remote Monitoring
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
CGM-Tele-monitoring Type 1 Tele-CGM-monitoring: Subjects are remotely monitored daily through a continuous glucose monitoring (CGM) system (Libre 2) that communicates via smart phone to a Libreview designed dashboard. Alerts set for: ≥4 hours without CGM signal, ≥2 hours 54-70 mg/dl, and 15 minutes \<54 mg/dl. Libreview dashboard automatically emails daily alerts to the Certified Diabetes Care and Education Specialist (CDCES). If alerts occurr...더 보기 | Tele-Monitor DM Remote monitoring of CGM data to identify, contact, and provide diabetes management for patients who are having episodes of hypoglycemia, hyperglycemia and/or difficulty using their CGM device. |
CGM-Tele-monitoring Type 2 Tele-CGM-monitoring: Subjects are remotely monitored daily through a continuous glucose monitoring (CGM) system (Libre 2) that communicates via smart phone to a Libreview designed dashboard. Alerts set for: ≥4 hours without CGM signal, ≥2 hours 54-70 mg/dl, and 15 minutes \<54 mg/dl. Libreview dashboard automatically emails daily alerts to the Certified Diabetes Care and Education Specialist (CDCES). If alerts occurr...더 보기 | Tele-Monitor DM Remote monitoring of CGM data to identify, contact, and provide diabetes management for patients who are having episodes of hypoglycemia, hyperglycemia and/or difficulty using their CGM device. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
CGM - Tele-monitoring effects on HbA1c | Number of patients with decreased HbA1c as measured by point of care HbA1c level from baseline to 12 months. | 12-months |
| 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 12 months | 12-months |
CGM-Tele-monitoring effects on glucose time in range (TIR) | Number of patients with weekly increased percent of time their glucose is in range (TIR; CGM glucose levels between 70-180) as assessed by CGM data download from baseline to 12 months | 12-months |
CGM-Tele-monitoring effects on depression | Number of patients with decreased depression as measured by PHQ 8 from baseline to 12 months. | 12 months |
CGM-Tele-monitoring effects on glucose monitoring satisfaction | Number of patients with increased glucose monitoring satisfaction as measured by GMSS from baseline to 12 months. | 12 months |
CGM-Tele-monitoring effects on diabetes treatment satisfaction | Number of patients with decreased depression as measured by DTSQ from baseline to 12 months. | 12 months |
CGM-Tele-monitoring effects on diabetes treatment satisfaction | Number of patients with increased diabetes treatment satisfaction as measured by DTSQ from baseline to 12 months. | 12 months |
CGM-Tele-monitoring effects on protocol driven enhancement of therapy with Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA) and sodium-glucose cotransporter -2 (SGLT-2) inhibitors | Number of patients with new prescriptions for GLP-1 RA and SGLT-2 inhibitors from baseline to 12 months. | 12 months |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Diagnosis of type 1 or type 2 diabetes for at least 6 months
- HbA1C >8% or any episode of level three hypoglycemia or diabetic ketoacidosis (DKA) in the past 6 months or at least once weekly episodes of level 1 or 2 hypoglycemia
- Age >18 years old
- On medication for treatment of diabetes-any oral or injectable agents on a stable dose of medication for at least 3 months.
- If on insulin performing blood glucose monitoring (BGM) at least 3 times per week
- Patients may be current continuous glucose monitor (CGM) users, prior CGM users or naïve to CGM.
- No serious illnesses where life expectancy is <1 year
- 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 or access to a computer that can connect to LibreView.
- Under the care of a Los Angeles County + University of Southern California provider who can prescribe diabetes medications and make dose adjustments/medication intensification as needed.
- Severe tape allergy
- Visual impairment such that CGM data cannot be viewed.
- On dialysis
- History of an adverse reaction to wearing CGM in the past (e.g., increased anxiety and/or an increase in acute diabetes complications such as DKA/severe hypoglycemia).
- Subject is currently pregnant or lactating or plan on becoming pregnant during the course of the study.
- Subject cannot follow instructions due to a medical condition or mental illness.
서던캘리포니아 대학교224개의 진행 중인 임상시험 탐색 가능연구 책임자
Anne Peters, 책임연구자, Professor, University of Southern California
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
California
University of Southern California Eastside Center for Diabetes, Los Angeles, California, 90022, United States