임상 레이더 AI | ||
|---|---|---|
임상시험 NCT06089070 (FREE CGM)은(는) 제2형 당뇨병에 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
검색으로 돌아가기
캘리포니아 대학교 샌프란시스코Continuous Glucose Monitoring System Feasibility in Youth With T2D (FREE CGM) 20
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 NCT06089070 (FREE CGM)은(는) 제2형 당뇨병에 대해 알아보는 중재연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2024년 1월 3일에 시작되어 20명의 참여자를 모집하고 있습니다. 캘리포니아 대학교 샌프란시스코이(가) 진행하며, 2027년 12월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 8일에 갱신되었습니다.
간단한 개요
The primary scientific question of this proposal is to investigate whether youth with T2D will wear and interact with a continuous glucose monitor (CGM) system and whether this will influence behavior and management decisions. There will be 30 participants enrolled in the study. 20 in the treatment arm and 10 in the control. The length of study participation will be 6 months for each participant.
상세한 설명
At the beginning of the study, participants will be asked to complete surveys where demographic, clinical and behavioral data will be collected. We will ask participants to wear a glucose sensor that is "blinded" for 14-days so that we can gather baseline data about blood sugar levels.
Participants must wear the CGM sensor for at least 10 days out of the 14 days of the blinding period to move on to the next part of ...
더 보기공식 제목
Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)
질환명
제2형 당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- FREE CGM
- 22-38272
NCT 번호
실제 연구 시작일
2024-01-03
최신 업데이트 게시
2025-09-08
예상 연구 완료일
2027-12-01
계획된 등록 인원
20
연구종류
중재연구
단계/상
해당 없음
상태
진행중, 모집종료
키워드
freestyle libre
continuous glucose monitor
type 2 diabetes
T2D
pediatric
continuous glucose monitor
type 2 diabetes
T2D
pediatric
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
비개입Control Participants will not have access to view the data from the CGM sensor during the screening period, nor during the main part of the study. | 해당 없음 |
실험적Intervention Participants will wear the CGM sensor and have access to the data during the main part of the study. | FreeStyle Libre Continuous Glucose Monitor System Continuous Glucose Monitor System for people with Type 2 Diabetes |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Ability to use CGM | Use of CGM measured by number of hours participants in the intervention arm wear the CGM device and view data on the mobile application. | Measured at 6 months |
Acceptability of CGM use measured with Acceptability of Intervention Measure (AIM) | The perception that CGM use is agreeable or satisfactory measured with the 4-item Acceptability of Intervention Measure (AIM). Greater the score, higher the acceptability | Measured at 6 months |
Appropriateness of CGM use measured with Intervention Appropriateness Measure | The perceived fit of the CGM to improve diabetes related metrics measured with the 4-item Intervention Appropriateness Measure (IAM). Greater the score, higher the appropriateness of CGM use | Measured at 6 months |
Feasibility of CGM use measured with Feasibility of Intervention Measure. | The extent to which a CGM study can be successfully carried out measured with 4-item Feasibility of Intervention Measure (FIM). The higher the score, the greater the feasibility of CGM use | Measured at 6 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Glycemic change | Change in HbA1C at 6 months adjusted for the baseline value youth with T2D. | Baseline (0) to 6 months |
Time in target glucose range | Time spent in target glucose range of 70 to 180 mg/dL | Baseline (0) to 6 months |
Time above high glucose range | percent of readings and time \>250 mg/dL | Baseline (0) to 6 months |
Time above glucose range | percent of readings and time 181-250 mg/dL | Baseline (0) to 6 months |
Time below glucose range | percent of readings and time 54-69 mg/dL | Baseline (0) to 6 months |
Time below low glucose range | percent of readings and time \<54 mg/dl | Baseline (0) to 6 months |
Glucose management indicator | CGM metric that indicates average blood glucose | Baseline (0) to 6 months |
Co-efficient of variation of glucose | CGM metric that measures variability in CGM values | Baseline (0) to 6 months |
Change in BMI | Change in BMI SDS over the course of the study | Baseline (0) to 6 months |
Frequency of taking diabetes medications | Self-reported medication adherence in the past week before visit | Baseline (0) to 6 months |
Starting or stopping medications | Percentage of subjects with addition or removal of diabetes medications | Baseline (0) to 6 months |
Titration of insulin dosing by provider | Percentage of subjects who receive insulin dose titration | Baseline (0) to 6 months |
Dietary measures | Change in score on SEARCH for Diabetes in Youth food frequency questionnaire. This is a 85 question survey ( Mayer-Davis EJ, Nichols M, Liese AD et al. (2006) Dietary intake among youth with diabetes: the SEARCH for Diabetes in Youth Study. J Am Diet Assoc.2006) | Baseline (0) to 6 months |
Physical activity measures | Number of minutes of physical activity in the past week before visit. The greater the value the better the score. | Baseline (0) to 6 months |
Quality of Life score on survey | Pediatric Quality of Life Inventory Diabetes Module score. 33 item score. The greater the value the better the score. | Baseline (0) to 6 months |
Problem Areas in Diabetes | Problem Areas In Diabetes (PAID) Scale. 20 question survey. Higher the score, the worse the outcome | Baseline (0) to 6 months |
참여 도우미
적격성 기준
연령대
어린이, 성인
최소 연령
8 Years
참여 가능한 성별
전체
- Age 8- 20 years at the time of consent.
- Clinical diagnosis of type 2 diabetes.
- Duration of type 2 diabetes at least 4 weeks.
- HbA1C ≥ 6.5% .
- Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment).
- No use of CGM 90 days before screening visit.
- English or Spanish speakers.
- Willing to abide by recommendations and study procedures.
- Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
- Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, Zn-T8).
- Plan for undergoing bariatric surgery during the study period.
- Known history of significant mental illness or developmental delay impacting the ability to complete study activities independently.
- Known history of adrenal insufficiency, or ongoing renal or hepatic disease.
- Pregnancy or lactation.
- Currently undergoing cancer treatment or systemic treatment with steroids.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
캘리포니아 대학교 샌프란시스코701개의 진행 중인 임상시험 탐색 가능연락처 정보가 없습니다.
1 1개국에 임상시험 장소
California
University of California San Francisco (UCSF), San Francisco, California, 94158, United States