임상 레이더 AI | ||
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임상시험 NCT05849428은(는) 제1형 당뇨병, 제2형 당뇨병에 대해 미상 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Blood Glucose Differences Using CGMs Between the Left and Right Arm in Patients With Diabetes 10
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 NCT05849428은(는) 제1형 당뇨병, 제2형 당뇨병에 대해 알아보는 중재연구입니다. 현재 상태는 미상이며, 연구는 2023년 5월 1일에 시작되어 10명의 참여자를 모집하고 있습니다. University of the Pacific이(가) 진행하며, 2024년 3월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2023년 5월 8일에 갱신되었습니다.
간단한 개요
There are multiple CGMs that are FDA approved. However, there are few studies looking at the variability of measurements between the left and right arm, and none looking at this effect in diabetic patients. This study may identify if glucose differences exist in the left and right arm in patients with Type 1 or Type 2 Diabetes. Furthermore, it may point to future directions for research to standardize methods of gluc...더 보기
상세한 설명
The goal of this clinical trial is to determine the time-matched difference in glucose levels between the left arm and right arm in patients with Type 1 or Type 2 diabetes. The main objective aims to answer:
• Is there a difference in time-matched controlled glucose monitoring (CGM) - derived blood glucose between left and right arm in patients with Type 1 or Type 2 diabetes in target range (<70 mg/dL; 70-180 mg/dL...
더 보기공식 제목
Blood Glucose Differences Between Left Arm and Right Arm in Patients With Type 1 or Type 2 Diabetes Using a Continuous Glucose Monitor
질환명
제1형 당뇨병제2형 당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- IRB2023-25
NCT 번호
실제 연구 시작일
2023-05
최신 업데이트 게시
2023-05-08
예상 연구 완료일
2024-03
계획된 등록 인원
10
연구종류
중재연구
단계/상
해당 없음
상태
미상
주요 목적
기타
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
기타Measuring Arm Participants will wear 2 Freestyle Libre 3 sensors on each arm, 1 on the left and 1 on the right for 2 consecutive weeks (total of 14 days). | Freestyle Libre 3 Freestyle Libre 3 consists of a sensor that is applied to the back of the upper arm. The sensor is a penny-sized flexible filament placed beneath the skin surface to measure interstitial fluid. This sensor is applied utilizing a sensor applicator provided in the packaging. The sensor will continuously read interstitial glucose readings every minute and syncs with the Freestyle View app. At the completion of the study...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients with Type 1 or Type 2 Diabetes below target range (<70 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis below the target range (\<70 mg/dL). | 14 days |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients in target range (70-180 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (70-180 mg/dL). | 14 days |
Time-matched CGM-derived blood glucose differences between left arm and right arm in patients above target range (>180 mg/dL). | Data gathered from the CGM device will be sync'd with the Freestyle View app and made available to the study team for analysis at the target range (\>180180 mg/dL). | 14 days |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Adults 18-65 years of age
- Diagnosed with Type 1 or Type 2 Diabetes
- Willing to wear CGMs for 2 weeks on both arms
- Willing to attend 3 virtual calls meetings over the course of the trial
- Have active health insurance
- Willing to refrain from any heat therapy for the duration of the study
- Willing to refrain from consuming ascorbic acid and salicylic acid for the duration of the study due to known interaction with CGMs
- Have access to 2 compatible mobile devices for the Freestyle Libre 3 CGMs
- Not currently using any Freestyle Libre CGM
- Willing to provide HbA1c readings within 3 months of the trial
- Have a baseline HbA1c equal or above 6.5
- Any active dermatologic condition on the upper arms
- Implanted medical devices including another continuous glucose monitoring device (i.e.
pacemaker)
- Critically ill or dialysis patients
- Planned magnetic resonance imaging screening, computed tomography scan, X-ray imaging or high-frequency electrical heat treatment during study period
- Current systemic infections
- Subjects who are unable to fully understand the study or consent process will not be included in the study due to the lack of a qualified medical translator
- Refusal to sign the informed consent document
- Pregnant, planned pregnancy during study period, or currently breast-feeding
- Fear of needles to the point where patients cannot self-administer the sensors
- History of allergic reactions or hypersensitivity from adhesives
University of the Pacific연구 책임자
Sachin Shah, 책임연구자, Professor of Pharmacy, University of the Pacific
연구 대표 연락처
연락처: Sarika Mujumdar, PharmD, 209-946-7754, [email protected]
연락처: Allen Lat, PharmD, 209-946-7754, [email protected]
1 1개국에 임상시험 장소
California
University of the Pacific, Stockton, California, 95211, United States
Sachin Shah, 연락처, [email protected]
모집중