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임상시험 NCT03566693 (MOBILE)은(는) 제2형 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE) 176 원격 참여
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 NCT03566693 (MOBILE)은(는) 제2형 당뇨병에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2018년 7월 30일에 시작되어 176명의 참여자와 함께 진행되었습니다. DexCom, Inc.이(가) 진행한 이 연구는 2021년 1월 4일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2021년 4월 21일에 갱신되었습니다.
간단한 개요
A study to compare the glycemic and quality of life benefits of diabetes management using Dexcom G6 continuous glucose monitoring (CGM) or self-monitored blood glucose (SMBG) made by study participants and their primary care physicians. Decisions will be based on insights from real-time use and retrospective insights, determined during remote visits.
Participants will have type 2 diabetes and be using basal insulin ...
더 보기상세한 설명
The study is referred to as the "Continuous Glucose MOnitoring in T2D Basal InsuLin UsErs, also known as The MOBILE Study" and will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus traditional Blood Glucose Monitoring (BGM) in people with Type 2 Diabetes using basal insulin with or without oral medications and who have an elevated HbA1c between 7.8 -11.5%. In this study, the investigator'...더 보기
공식 제목
Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)
질환명
제2형 당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- MOBILE
- PTL-902822
NCT 번호
실제 연구 시작일
2018-07-30
최신 업데이트 게시
2021-04-21
예상 연구 완료일
2021-01-04
계획된 등록 인원
176
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 |
|---|---|
실험적Continous Glucose Monitor | Dexcom G6 CGM System continuous glucose monitor |
활성 대조군Self Monitoring Blood Glucose | Blood glucose meter Blue-tooth enabled blood glucose meter |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 1: Change in HbA1c | Phase 1: Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to Month 8 | Baseline to Month 8 |
Phase 2: Change in CGM time in target range | Between group differences for the Phase 1 CGM Group re-randomized to Discontinue CGM (use SMBG only) or to Continue CGM for the change in time in target range (70-180 mg/dL) from Month 8 to Month 14 | Month 8 to Month 14 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 1: Change in CGM time in target range | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time in target range 70-180 mg/dL | Baseline to Month 8 |
Phase 1: Change in CGM time-hyperglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as \>250 mg/dL | Baseline to Month 8 |
Phase 1: Change in mean glucose from CGM | Between group differences (CGM and SMBG) from baseline to Month 8 of change in mean glucose from CGM | Baseline to Month 8 |
Phase 1: Percent decreasing HbA1c by ≥0.5% | Between group differences (CGM and SMBG) from baseline to Month 8 of percent decreasing HbA1c by ≥0.5% (absolute) | Baseline to Month 8 |
Phase 1: Proportion increasing CGM time in target range by ≥10% and ≥15% | Between group differences (CGM and SMBG) from baseline to Month 8 of proportion increasing CGM time in target range by ≥10% and ≥15% (absolute) | Baseline to Month 8 |
Phase 1: Percent adding or removing diabetes medications | Between group differences (CGM and SMBG) from baseline to Month 8 of percent adding or removing diabetes medications (starting or stopping medications) | Baseline to Month 8 |
Phase 1: Change in HbA1c based on their baseline HbA1c | Between group differences (CGM and SMBG) from baseline to Month 8 of change in HbA1c based on their baseline HbA1c (restricted to participants with baseline HbA1c ≥8.5%,≥9.0%, ≥9.5%, ≥10.0%) | Baseline to Month 8 |
Phase 1: Change in CGM glucose variability | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM glucose variability measured by the coefficient of variation | Baseline to Month 8 |
Phase 1: Change in CGM time-hypoglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hypoglycemic, defined as \<70mg/dL | Baseline to Month 8 |
Phase 2: Change in HbA1c | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in HbA1c (central lab) | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Change in CGM time-hyperglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as \>250 mg/dL | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Percent decreasing HbA1c by ≥0.5% | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of percent decreasing HbA1c by ≥0.5% (absolute) | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Proportion increasing CGM time in target range by ≥10% and ≥15% | Month 8 to Month 14 \& Baseline to Month 14 | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of proportion increasing |
Phase 2: Percent adding or removing diabetes medications | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of percent adding or removing diabetes medications (starting or stopping medication) | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Change in CGM glucose variability | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in CGM glucose variability measured by the coefficient of variation | Month 8 to Month 14 & Baseline to Month 14 |
Phase 2: Change in CGM time-hypoglycemic | Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in CGM time-hypoglycemic, defined as \<70mg/dL | Month 8 to Month 14 & Baseline to Month 14 |
적격성 기준
연령대
성인, 노인
최소 연령
30 Years
참여 가능한 성별
전체
- Age 30 or older
- Diagnosis of Type 2 diabetes
- HbA1c between 7.8-11.5%
- Use of basal insulin, with or without concomitant use of oral agents or GLP-1 agonist
- Pregnancy
- Renal disease
- Conditions that impact the stability of a HbA1c measurement
- Use of prandial insulin
DexCom, Inc.Jaeb Center for Health Research연락처 정보가 없습니다.
15 1개국에 임상시험 장소
California
Keck School of Medicine @ USC, Los Angeles, California, 90022, United States
Scripps Whittier Diabetes Institute, San Diego, California, 92121, United States
Georgia
Emory University, Atlanta, Georgia, 30303, United States
Illinois
Northwestern Memorial, Chicago, Illinois, 60611, United States
Iowa
Iowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, 50265, United States
Michigan
University of Michigan Internal Medicine, Ann Arbor, Michigan, 48105, United States
Henry Ford Medical Center, Detroit, Michigan, 48202, United States
Minnesota
Park Nicollet International Diabetes Center, Minneapolis, Minnesota, 55416, United States
Missouri
Washington University Barnes Jewish Hospital, St Louis, Missouri, 63130, United States
Nevada
Las Vegas Endocrinology, Henderson, Nevada, 89052, United States
North Carolina
University of North Carolina, Chapel Hill, North Carolina, 27517, United States
Carteret Medical Group, Morehead City, North Carolina, 28557, United States
Lucas Research / Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States
Tennessee
Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37212, United States
Texas
Amarillo Medical Specialists, LLP, Amarillo, Texas, 79106, United States