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CGM - Reimagine Primary Care 4상 101

완료
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임상시험 NCT04413578은(는) 치료을(를) 알아보기 위한 연구였습니다. 이 연구는 제2형 당뇨병에 대한 것이었으며, 완료 된 4상 중재연구이었습니다. 연구는 2018년 12월 1일에 시작되어 101명의 참여자와 함께 진행되었습니다. 인터마운틴 헬스이(가) 진행한 이 연구는 2019년 12월 31일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2020년 6월 4일에 갱신되었습니다.
간단한 개요
To assess the impact of continuous glucose monitoring versus standard of care (e.g. a finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and cost in patients with type I or II diabetes treated within the Reimagine Primary Care clinics.
상세한 설명
This is a parallel randomized controlled trial. Eligible patients who consent will be randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for CGM, or (2) the control group who will follow their current standard finger-prick protocol via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and Clarity mobile apps for data capture, whereas the standard ...더 보기
공식 제목

Assessing the Feasibility of Continuous Glucose Monitoring in Reimagine Primary Care Clinics

질환명
제2형 당뇨병
출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.
기타 연구 식별자
  • 1050955
NCT 번호
NCT04413578
실제 연구 시작일
2018-12-01
최신 업데이트 게시
2020-06-04
예상 연구 완료일
2019-12-31
계획된 등록 인원
101
연구종류
중재연구
단계/상
4상
상태
완료
키워드
Continuous Glucose Monitor (CGM)
Dexcom G6
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Dexcom G6 (Intervention Group)
• Intervention group: CGM using a Dexcom G6 to measure glycosylated hemoglobin levels every five minutes. Patients will be asked to download the Dexcom G6 and Clarity applications (to have access to their real-time data) and be given a link to complete an exit survey in REDCap near the end of their study participation. Data will be sent via Bluetooth and then exported by the Intermountain research team into a Tableau...더 보기
Dexcom G6
Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.
위약 대조군Contour NextOne (Standard of Care) Glucometer
• Control group: A standard finger-prick protocol that will require patients to continue with their daily fingerprick regimen established by their physician. This group will be given a Contour Next One meter to ensure that each patient is receiving the same level of accuracy by the same device. A review by Ekhlaspour et al of 17 glucose meters demonstrated wide variability, with only two devices achieving the 2013 IS...더 보기
Contour NextOne
A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.
주요결과변수
결과변수측정값 설명시간 범위
HbA1c Variation
Coefficient of variation in HbA1c levels before, during and end of study completion.
6 months
HbA1c Range
Variation of range in HbA1c levels before, during and end of study completion.
6 months
이차결과변수
결과변수측정값 설명시간 범위
Current Diabetes Standards
Current HEDIS performance on diabetes and behavioral health measures.
6 months
Behavioral Changes
Subjects will complete a self reported survey related to behavioral changes at end of study to assess self empowered behavioral changes after using the devices (e.g. feeling more empowered to self-manage care, engaged with changing healthcare behaviors, and patient perceptions of the technology).
6 months
Hypoglycemic Events
Frequency of hypoglycemic events during the study.
6 months
Healthcare Utilization
Healthcare utilization per count of inpatient/outpatient visits.
6 months
Glycemic Variability
Glycemic variability per mean amplitude of glycemic excursion (MAGE)
6 months
Emergency Room Visits
Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to.
6 months
Healthcare Cost
Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc.
6 months
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
  • Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5%
  • Patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be prescribed one by their healthcare provider)
  • Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood Family Medicine, Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal Medicine). • Patients 18-80 years of age

  • Patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor by their physician)
  • Patients that are not treated within the four Reimagine Primary Care clinics
  • Patients less than 18 years of age, and 81 years of age and older
  • Patients with a diagnosis of dementia
  • If the patient is currently using a Continuous Glucose Monitor
  • Patients with previous hospitalization for hypoglycemia within the last 18 months
  • No access to a mobile phone to download the Dexcom or Contour Next applications
  • Patients who are pregnant or planning to become pregnant over the course of their six-month participation
Intermountain Health Care, Inc. logo인터마운틴 헬스27개의 진행 중인 임상시험 탐색 가능
연락처 정보가 없습니다.
4 1개국에 임상시험 장소

Utah

Holladay Internal Medicine, Holladay, Utah, 84121, United States
Intermountain Cottonwood Family Practice, Murray, Utah, 84107, United States
Intermountain Senior Clinic, Murray, Utah, 84107, United States
Avenues Internal Medicine, Salt Lake City, Utah, 84103, United States