임상 레이더 AI | ||
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임상시험 NCT05121844은(는) 체중 감소, 대사 증후군, 당뇨 전 단계, 중심 비만, 포도당 불내성, 대사성 포도당 장애에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform 31,187 식이 요법 운동
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 NCT05121844은(는) 체중 감소, 대사 증후군, 당뇨 전 단계, 중심 비만, 포도당 불내성, 대사성 포도당 장애에 대해 알아보는 중재연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2021년 11월 2일에 시작되어 31,187명의 참여자를 모집하고 있습니다. Signos Inc이(가) 진행하며, 2027년 11월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 8월 24일에 갱신되었습니다.
간단한 개요
Metabolic syndrome and resulting downstream health effects remains a growing health concern. In published trials, the use of continuous glucose monitoring (CGM) assists behavioral changes efforts, leading to improved adherence and results from diet and exercise changes in individuals with obesity, pre-diabetes and diabetes. Mobile health (mHealth) platforms provide satisfactory, easy-to-use tools that help participan...더 보기
상세한 설명
The scope of this study is to enroll existing and new Signos users in a volunteer study that utilizes a continuous glucose monitor (CGM) and mobile health application \[Signos\] to optimize general wellness and body weight and composition. This is a no more than minimal risk study.
공식 제목
Use of Continuous Glucose Monitoring in Non-Diabetic Population to Compliment Signos Mobile Health Platform: Comprehensive Weight Optimization Program and Customized Lifestyle Modifications
질환명
체중 감소대사 증후군당뇨 전 단계중심 비만포도당 불내성대사성 포도당 장애출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- 195165
NCT 번호
실제 연구 시작일
2021-11-02
최신 업데이트 게시
2025-08-24
예상 연구 완료일
2027-11-01
계획된 등록 인원
31,187
연구종류
중재연구
단계/상
해당 없음
상태
진행중, 모집종료
키워드
health and wellness
excess adiposity
excess adiposity
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Signos digital health app and CGM For all consented participants, the Signos app will use CGM data to provide recommendations customized to users for promoting general health and wellness. | Continuous Glucose Monitor Device Continuous glucose monitoring automatically tracks blood glucose levels, also called blood sugar, throughout the day and night. You can see your glucose level anytime at a glance. You can also review how your glucose changes over a few hours or days to see trends. Seeing glucose levels in real time can help you make more informed decisions throughout the day about how to balance your food and physical activity. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Average fasting glucose | Daily fasting glucose, averaged periodically | During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. |
Change in weight | Change in number of pounds | During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Body composition | User input data including percentage of body fat or other measurements of body composition | During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. |
Time in range | percentage of time spent "in range" glucose level less than 140 or as determined by other parameters | During enrollment in the trial for a maximum of 5 years, including a 1 year follow up period, for a maximum of 6 years. |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
- 18 years and above
- Own a smartphone and be willing to install the Signos App to use the app, receive messages or notifications, and input weight and other data.
- Willingness to complete questionaries or other surveys
- Able to speak and read English
- Medical diagnosis of Type 1 Diabetes
- Medical diagnosis of Type 2 Diabetes
- Current medical diagnosis of an eating disorder (anorexia or bulimia) or previously struggled with disordered eating behaviors with current BMI less than 24
- Medical conditions (e.g., such as seizure disorder) requiring a specific medical diet.
- Inborn errors of metabolism such as phenylketonuria (PKU), glycogen storage disease, fructose intolerance, Maple Sugar Urine Disease (MSUD).
- Chronic or severe disease (e.g, chronic obstructive pulmonary disease \[COPD\], coronary artery disease, cerebrovascular accident \[CVA\], or cardiac arrhythmia) that would preclude a subject from safely participating in dietary recommendations and/or physical activity
- History of Gastric bypass or other bariatric surgery
- History of 10 or more soft tissue skin infections (such as cellulitis or abscesses)
- Intolerable skin reaction from adhesive
- Currently taking any of the following medications: Hydroxyurea, insulin, sulfonylureas, or medications prescribed specifically for the treatment of diagnosed diabetes
- Vulnerable populations such as minors, prisoners, or pregnant women will not be enrolled in this study. Women who become pregnant will be excluded at that time.
- Inability or unwillingness of subject to give informed consent
Signos Inc연구 책임자
Stephanie Kim, M.D., MPH, 책임연구자, Principal Investigator, Signos Inc
연락처 정보가 없습니다.
1 1개국에 임상시험 장소
California
Signos, Palo Alto, California, 94306, United States