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임상시험 NCT01614262은(는) DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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노스캐롤라이나 대학교 채플힐Examining The Role of CGM in T2DM 35
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 NCT01614262은(는) DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2012년 6월 1일에 시작되어 35명의 참여자와 함께 진행되었습니다. 노스캐롤라이나 대학교 채플힐이(가) 진행한 이 연구는 2014년 9월 1일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2017년 4월 19일에 갱신되었습니다.
간단한 개요
Continuous glucose monitoring (CGM) technology has advanced the treatment of people with diabetes, however to date this technology had been primarily limited to use in patients treated with insulin. CGM is a powerful tool that has the potential to enhance the care of patients treated with agents other than insulin; however this has not been tested. The purpose of this study is to determine whether improved glycemic c...더 보기
상세한 설명
The study will enroll and follow 90 participants for 187 days at two sites. Participants will be randomized (1:1 allocation ratio) to the CGM based intervention (Group 1) or the Self-Monitoring Blood Glucose (SMBG) based intervention (Group 2). Group 1 will receive care based upon the results of their CGM data while group 2 will receive care based upon traditional SMBG values. The clinical management algorithm will b...더 보기
공식 제목
Examining the Role of Continuous Glucose Monitoring (CGM) in Non-Insulin Treated Type 2 Diabetes
질환명
DIABETES MELLITUS, NONINSULIN-DEPENDENT, 2 (Disorder)기타 연구 식별자
- 12-0899
NCT 번호
실제 연구 시작일
2012-06
최신 업데이트 게시
2017-04-19
예상 연구 완료일
2014-09
계획된 등록 인원
35
연구종류
중재연구
단계/상
해당 없음
상태
완료
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Continuous Glucose Monitoring The Continuous Glucose Monitoring (CGM) arm will receive care based upon results from there CGM data; treatment decisions are based on algorithm and CGM data | Continuous Glucose Monitoring with treatment algorithm those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM. |
활성 대조군Self Monitoring Blood Glucose Subjects in the Self Monitoring Blood Glucose group will have treatment decisions based on self monitored blood glucose values and not CGM values, per current standard of care. | Continuous Glucose Monitoring with treatment algorithm those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
change in glycosylated hemoglobin using intensive periodic CGM monitoring vs traditional monitoring | baseline and day 187 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
change in fasting plasma glucose between two groups | baseline and day 187 | |
comparison of change of the area under the curve for CGM results for both treatment arms | baseline and day 187 | |
quality of life data evaluation | Provide preliminary data on the effect of CGM monitoring on subjects' quality of life. | baseline and day 187 |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
A subject is eligible for the study if all of the following criteria are met:
- Provide written informed consent prior to enrollment
- Is male or female between 18-70 years old
- Has been treated by the Principal Investigator or referring physician in the same practice.
- Has Type 2 Diabetes Mellitus for greater than 12 months on 1-3 antihyperglycemic medications, on a stable dose for 90 days prior to screening.
- Has a HbA1c between 7.5-9.0% in the 90 days prior to screening.
- Currently performs self-monitoring blood glucose checks at least 3 times per week.
- Ability to adhere to protocol requirements.
1. Has Type 1 Diabetes or Gestational Diabetes
2.Is pregnant or planning to become pregnant during the course of the study.
3.Current use of any insulin or history of insulin use in the last 6 months.
4.An acute coronary or cerebrovascular event in the previous 3 months.
5.Any planned surgery during the course of the study.
6.Current continuous renal replacement therapy.
7.BMI ≥ 45 kg/m^2
8.Current oral or injectable steroid use.
9.Any previous history Continuous Glucose Monitoring use by any device or manufacturer.
10.Has a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
노스캐롤라이나 대학교 채플힐241개의 진행 중인 임상시험 탐색 가능- 🏛️Medtronic
연락처 정보가 없습니다.
2 1개국에 임상시험 장소
Georgia
Atlanta Diabetes Assoicates, Atlanta, Georgia, 30309, United States
North Carolina
University of North Carolina, Chapel Hill, North Carolina, 27599, United States