이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System (STRIVE 2)

2026년 5월 28일 업데이트: Insulet Corporation

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5.

After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses

연구 유형

중재적

등록 (추정된)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • California
      • Los Angeles, California, 미국, 90022
        • 아직 모집하지 않음
        • University of Southern California
        • 연락하다:
        • 수석 연구원:
          • Anne Peters
      • Santa Barbara, California, 미국, 93105
        • 모병
        • Sansum Diabetes Research Institute
        • 수석 연구원:
          • Kristin Castorino
        • 연락하다:
    • Colorado
      • Aurora, Colorado, 미국, 80045
        • 아직 모집하지 않음
        • University of Colorado
        • 수석 연구원:
          • Gregory Forlenza
        • 연락하다:
    • Connecticut
      • New Haven, Connecticut, 미국, 06511
        • 아직 모집하지 않음
        • Yale
        • 연락하다:
        • 수석 연구원:
          • Amy Steffen
    • Florida
      • Tampa, Florida, 미국, 33612
        • 아직 모집하지 않음
        • University of South Florida
        • 연락하다:
        • 수석 연구원:
          • Dorothy Shulman
    • Georgia
      • Atlanta, Georgia, 미국, 30308
        • 아직 모집하지 않음
        • Emory University
        • 연락하다:
          • Sabeena Usman
        • 수석 연구원:
          • Georgia Davis
    • Illinois
      • Chicago, Illinois, 미국, 60611
        • 아직 모집하지 않음
        • Northwestern University
        • 수석 연구원:
          • Grazia Aleppo
        • 연락하다:
    • Indiana
      • Indianapolis, Indiana, 미국, 46202
        • 아직 모집하지 않음
        • Indiana University
        • 수석 연구원:
          • Viral Shah
        • 연락하다:
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
    • Michigan
      • Detroit, Michigan, 미국, 48202
        • 모병
        • Henry Ford Health Systems
        • 수석 연구원:
          • Davida Kruger
        • 연락하다:
    • Minnesota
      • Minneapolis, Minnesota, 미국, 55416
        • 모병
        • Health Partners
        • 연락하다:
        • 수석 연구원:
          • Amy Criego
    • Texas
      • Houston, Texas, 미국, 77030
        • 아직 모집하지 않음
        • Baylor College of Medicine
        • 연락하다:
        • 수석 연구원:
          • Daniel DeSalvo

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Age at time of consent 14-75 years (inclusive)
  • Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
  • Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
  • HbA1c ≥ 7.5%
  • Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user
  • Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user
  • Currently using a continuous glucose monitor
  • Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.
  • Participant agrees to provide their own insulin for the duration of the study
  • Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
  • Willing to wear the system continuously throughout the study
  • Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged < 18 years per local regulatory requirements
  • Able to read and understand English and operate the study device in English
  • If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

  • Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
  • Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, 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 12 months prior to screening
  • Any planned surgery during the study which could be considered major in the judgment of the investigator
  • History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
  • History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
  • Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
  • Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
  • Use of hydroxyurea
  • Plans to receive blood transfusion over the course of the study
  • Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
  • Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.
  • Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening
  • Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).
  • Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period
  • 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
  • Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Omnipod 5 System
장치: Omnipod 5 System
The Omnipod 5 System with the study CGM
실험적: Omnipod 6 System
장치: Omnipod 6 System
The Omnipod 6 System with the study CGM

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Time in Range 70-180 mg/dL
기간: 13 weeks
Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <54 mg/dL
기간: 13 weeks
Change in CGM percent time <54 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <70 mg/dL
기간: 13 weeks
Change in CGM percent time <70 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >180 mg/dL
기간: 13 weeks
Change in CGM percent time >180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time in Range 70-140 mg/dL
기간: 13 weeks
Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
HbA1c
기간: 13 weeks
Change in HbA1c (%) between Omnipod 6 and Omnipod 5
13 weeks
Mean sensor glucose
기간: 13 weeks
Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >250 mg/dL
기간: 13 weeks
Change in CGM percent time >250 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Total boluses per day
기간: 13 weeks
Total blues per day will be compared between Omnipod 6 and Omnipod 5
13 weeks
Total daily insulin per kg and total insulin delivered via automation
기간: 13 weeks
Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage of time in automated mode
기간: 13 weeks
Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with HbA1c <7.0% and <7.5%
기간: 13 weeks
Percentage with HbA1c <7.0% and <7.5% will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with >= 70% time in range
기간: 13 weeks
Percentage with >= 70% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with >= 50% time in range
기간: 13 weeks
Percentage with >= 50% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Diabetes treatment satisfaction
기간: 13 weeks
Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6
13 weeks
System Usability
기간: 13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
System Opinion
기간: 13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
Health Related Quality of Life (HR-QOL)
기간: 13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Hypoglycemia confidence
기간: 13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Missed Meal - Peak glucose
기간: 13 weeks
Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - AUC
기간: 13 weeks
AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Time in Range
기간: 13 weeks
Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time > 180 mg/dL
기간: 13 weeks
Percentage of Time > 180 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time > 250 mg/dL
기간: 13 weeks
Percentage of Time > 250 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time <54 mg/dL
기간: 13 weeks
Percentage of Time <54 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time <70 mg/dL
기간: 13 weeks
Percentage of Time <70 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Number of severe hypoglycemic events
기간: 13 weeks
13 weeks
Number of DKA or HHS events
기간: 13 weeks
13 weeks
Other related serious adverse events
기간: 13 weeks
13 weeks
Unanticipated adverse device effects
기간: 13 weeks
13 weeks
Reportable device-related adverse events
기간: 13 weeks
13 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Insulet Corporation

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 13일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2026년 4월 30일

QC 기준을 충족하는 최초 제출

2026년 5월 6일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 28일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STRIVE 2

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

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. .

제2형 당뇨병에 대한 임상 시험

Omnipod 5 System에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Senegal

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다