임상 레이더 AI | ||
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임상시험 NCT04320069은(는) 제1형 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study 25
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 NCT04320069은(는) 제1형 당뇨병에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2020년 6월 9일에 시작되어 25명의 참여자와 함께 진행되었습니다. Insulet Corporation이(가) 진행한 이 연구는 2020년 9월 29일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2023년 11월 13일에 갱신되었습니다.
간단한 개요
Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.
상세한 설명
The study schedule consists of two outpatient phases:
- 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by;
- 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2)
Following subject screening, system training and enrollment, subjects will com...
더 보기공식 제목
Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes
질환명
제1형 당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- G200018
NCT 번호
실제 연구 시작일
2020-06-09
최신 업데이트 게시
2023-11-13
예상 연구 완료일
2020-09-29
계획된 등록 인원
25
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
T1D
Omnipod
Omnipod
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Omnipod Horizon™ Automated Glucose Control System All subjects using the Omnipod Horizon™ Automated Glucose Control System in Manual Mode without a connected CGM for 7 days and with a connected CGM for 7 days. | Omnipod Horizon™ Automated Glucose Control System Omnipod Horizon™ Automated Glucose Control System use in Manual Mode |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Percentage of Time <70 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
Percentage of Time >180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Mean Glucose | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
Percentage of Time <54 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
Percentage of Time ≥ 250 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
Percentage of Time ≥ 300 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
Percentage of Time in Range 70-180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1 (comparing the 4-hour post bolus period) |
Mean Glucose | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Percentage of Time <54 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Percentage of Time <70 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Percentage of Time >180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Percentage of Time ≥ 250 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Percentage of Time ≥ 300 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Percentage of Time in Range 70-180 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Percentage of Time in Range 70-140 mg/dL | Glucose metric from continuous glucose monitoring system (CGM) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Standard Deviation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
Coefficient of Variation | Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV) | Phase 2 compared to Phase 1, during the day (6AM up to 12AM), overnight (12AM up to 6AM), and overall |
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
2 Years
참여 가능한 성별
전체
- Age at time of consent/assent 2-70 years
- Subjects aged < 18 years must be living with parent/legal guardian
- Diagnosed with type 1 diabetes for at least 6 months. Diagnosis is based on investigator's clinical judgment
- Must be a current Omnipod user, or have used an Omnipod in the past
- Investigator has confidence that the subject, parent, or legal guardian, can successfully operate all study devices and can adhere to the protocol
- Willing to use only the following types of Insulin during the study: Humalog, Novolog, Admelog, or Apidra
- Must be willing to use the Omnipod Horizon™ in Manual Mode only and agree not to use Automated Mode functionality
- Must be willing to use the Omnipod Horizon™ bolus calculator without a connected CGM for the first 7-days of Manual Mode (Phase 1) while manually entering BG values to deliver boluses
- Must be willing to use the Omnipod Horizon™ bolus calculator with a connected CGM for the last 7-days of Manual Mode (Phase 2) using the CGM-informed bolus calculator to deliver boluses
- Willing to wear the system continuously throughout the study
- For subjects not currently enrolled in the Omnipod Horizon™ Pivotal Study (G190270), A1C <10%
- Must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (except for the Dexcom Follow App)
- Able to read and speak English fluently (if subject is a young child then Caregiver must meet the criteria)
- Willing and able to sign the Informed Consent Form (ICF) and/or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from subjects aged < 18 years per State requirements.
- For subjects aged 2-5.9 years of age, parents or trained caregivers agree to be physically present during the decision and delivery of insulin boluses for this age group, as well as agree to be available for glucose monitoring and treatment during the 4-hour post bolus period.
- A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk
- History of severe hypoglycemia in the past 6 months
- History of DKA in the past 6 months, unrelated to an intercurrent illness or infusion set failure
- Plans to receive blood transfusion over the course of the study
- Currently diagnosed with anorexia nervosa or bulimia
- Acute or chronic kidney disease or currently on hemodialysis
- History of adrenal insufficiency
- Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study
- Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
- Plans to use insulin other than U-100 insulin intended for use in the study device during the study
- Use of non-insulin anti-diabetic medication other than metformin (e.g. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide)
- Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12 months
- Clinical signs of hypothyroidism and hyperthyroidism
- Pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant)
- Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of the pivotal study after study pause.
- Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment
Insulet Corporation연락처 정보가 없습니다.
4 1개국에 임상시험 장소
California
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
Colorado
University of Colorado Denver, Denver, Colorado, 80045, United States
Georgia
Atlanta Diabetes, Atlanta, Georgia, 30318, United States
Virginia
University of Virginia, Charlottesville, Virginia, 22904, United States