- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04904718
Real World Evaluation of Advisor Pro in Clinical Practice
To assess the integration of the DreaMed Advisor Pro tool into a real-world clinical practice using both in person and virtual visits to assess benefits in glycemia, as measured by the glucose management indicator and other glucose metrics.
To determine acceptability of the DreaMed Advisor Pro tool both from a person with diabetes as well as a health care provider perspective.
To quantify the potential reimbursement potential that could be generated with use of the DreaMed Advisor Pro.
연구 개요
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Participant with Type 1 diabetes
- Age ≥ 6 years to <30 years
Using Insulin infusion pump (CSII) therapy including those with low glucose suspend and predictive low glucose suspend features
- Insulin pump must not use automated insulin delivery (closed loop, artificial pancreas)
- Total daily dose of insulin must be greater than 0.5 units/kg/day
- Participants / parents are required to have minimum computer skills and access to a computer in order to upload their personal devices (Pump, BG meter etc) to Tidepool.
- Participants using Dexcom sensors will allow access to their account for the study duration
- Participants not using CGM must agree to test BG at least 4 times a day at appropriate intervals
- Participants / parents will have to have a smartphone (Apple or Android and Windows)
Exclusion Criteria:
- An episode of diabetic ketoacidosis within the month prior to study entry
- Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety,
- Current participation in any other interventional study
- Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
- Severe hypoglycemia within six months prior to enrollment as defined by the ADA and Endocrine Society
- Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)
- Participants suffers from an eating disorder
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: DreaMed Advisor Pro tool used for insulin optimization
|
Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data consisting of glucose levels, insulin delivery history and meal consumption reported
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in glucose control with the use of DreaMed
기간: 6 months
|
Glucose mangement indicator (GMI) will be used to determine glucose control.
The GMI indicates the average A1C level that would be expected based on mean glucose measured in a large number of individuals with diabetes.
Mean glucose ideally is derived from at least 14 days of CGM data
|
6 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
DreaMed Advisor Pro에 대한 임상 시험
-
Rabin Medical CenterThe Leona M. and Harry B. Helmsley Charitable Trust; DreaMed Diabetes모병
-
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RANDNorthwestern University; University of Pittsburgh Medical Center완전한
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