このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年5月28日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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

研究の種類

介入

入学 (推定)

200

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90022
        • まだ募集していません
        • University of Southern California
        • コンタクト：
        • 主任研究者：
          • Anne Peters
      • Santa Barbara、California、アメリカ、93105
        • 募集
        • Sansum Diabetes Research Institute
        • 主任研究者：
          • Kristin Castorino
        • コンタクト：
    • Colorado
      • Aurora、Colorado、アメリカ、80045
        • まだ募集していません
        • University of Colorado
        • 主任研究者：
          • Gregory Forlenza
        • コンタクト：
    • Connecticut
      • New Haven、Connecticut、アメリカ、06511
        • まだ募集していません
        • Yale
        • コンタクト：
        • 主任研究者：
          • Amy Steffen
    • Florida
      • Tampa、Florida、アメリカ、33612
        • まだ募集していません
        • University of South Florida
        • コンタクト：
        • 主任研究者：
          • Dorothy Shulman
    • Georgia
      • Atlanta、Georgia、アメリカ、30308
        • まだ募集していません
        • Emory University
        • コンタクト：
          • Sabeena Usman
        • 主任研究者：
          • Georgia Davis
    • Illinois
      • Chicago、Illinois、アメリカ、60611
        • まだ募集していません
        • Northwestern University
        • 主任研究者：
          • Grazia Aleppo
        • コンタクト：
    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
        • まだ募集していません
        • Indiana University
        • 主任研究者：
          • Viral Shah
        • コンタクト：
          • Kathy Bohanan
          • 電話番号：317-278-0651
          • メール：kkremer@iu.edu
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02215
    • Michigan
      • Detroit、Michigan、アメリカ、48202
        • 募集
        • Henry Ford Health Systems
        • 主任研究者：
          • Davida Kruger
        • コンタクト：
    • Minnesota
      • Minneapolis、Minnesota、アメリカ、55416
        • 募集
        • Health Partners
        • コンタクト：
        • 主任研究者：
          • Amy Criego
    • Texas
      • Houston、Texas、アメリカ、77030
        • まだ募集していません
        • Baylor College of Medicine
        • コンタクト：
        • 主任研究者：
          • Daniel DeSalvo

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：Omnipod 5 System
デバイス：Omnipod 5 System
The Omnipod 5 System with the study CGM
実験的：Omnipod 6 System
デバイス：Omnipod 6 System
The Omnipod 6 System with the study CGM

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time in Range 70-180 mg/dL
時間枠：13 weeks
Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <54 mg/dL
時間枠：13 weeks
Change in CGM percent time <54 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <70 mg/dL
時間枠：13 weeks
Change in CGM percent time <70 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >180 mg/dL
時間枠：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
時間枠：13 weeks
Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
HbA1c
時間枠：13 weeks
Change in HbA1c (%) between Omnipod 6 and Omnipod 5
13 weeks
Mean sensor glucose
時間枠：13 weeks
Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >250 mg/dL
時間枠：13 weeks
Change in CGM percent time >250 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Total boluses per day
時間枠：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
時間枠：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
時間枠：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%
時間枠：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
時間枠：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
時間枠：13 weeks
Percentage with >= 50% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Diabetes treatment satisfaction
時間枠：13 weeks
Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6
13 weeks
System Usability
時間枠：13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
System Opinion
時間枠：13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
Health Related Quality of Life (HR-QOL)
時間枠：13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Hypoglycemia confidence
時間枠：13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Missed Meal - Peak glucose
時間枠：13 weeks
Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - AUC
時間枠：13 weeks
AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Time in Range
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：13 weeks
13 weeks
Number of DKA or HHS events
時間枠：13 weeks
13 weeks
Other related serious adverse events
時間枠：13 weeks
13 weeks
Unanticipated adverse device effects
時間枠：13 weeks
13 weeks
Reportable device-related adverse events
時間枠：13 weeks
13 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Insulet Corporation

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月13日

一次修了 (推定)

2027年2月1日

研究の完了 (推定)

2027年2月1日

試験登録日

最初に提出

2026年4月30日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月1日

QC基準を満たした最後の更新が送信されました

2026年5月28日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STRIVE 2

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

2型糖尿病の臨床試験

Omnipod 5 Systemの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Mozambique

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所

購読する