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NO-Meal Announcement in Automated Insulin Delivery (Open-source and Commercial) Systems (NOMAD)

2026年8月6日 更新者：Rémi Rabasa-Lhoret、Institut de Recherches Cliniques de Montreal

Automated insulin delivery (AID) systems are the current gold standard for the management of type 1 diabetes (T1D), improving glycemic control, reducing hypoglycemia, and decreasing treatment burden. Although both commercial AID (C-AID) and open-source AID (OS-AID) systems have demonstrated significant clinical benefits, direct randomized comparisons between these systems remain scarce. Moreover, an important limitation of currently available AID systems is their reliance on user-initiated meal announcements and carbohydrate counting, which remain major contributors to postprandial dysglycemia and treatment burden. While emerging evidence suggests that AID systems may partially compensate for missed meal announcements, their comparative performance under these challenging real-world conditions is unknown.

The NOMAD study is an international, multicenter, open-label, randomized, non-inferiority crossover trial designed to compare an open-source AID system with commercially available AID systems (including Tandem Control-IQ and Omnipod 5) in adults with type 1 diabetes currently using an open-source AID system. The study specifically evaluates glycemic outcomes following standardized unannounced meal challenges performed under free-living conditions.

A total of 33 participants will be enrolled and complete two 4-week intervention periods, each consisting of a 2-week run-in phase followed by a 2-week data collection phase, with crossover between treatment arms. Participants will continue using their own Dexcom G6 or Dexcom G7 continuous glucose monitoring system throughout the study.

The primary outcome is the percentage of time spent in the target glucose range (3.9-10.0 mmol/L) during the 4 hours following standardized unannounced meal challenges. Secondary outcomes include additional CGM metrics (time above and below range, glucose variability, mean glucose, and GMI), insulin delivery characteristics, and patient-reported outcomes evaluating treatment satisfaction, usability, and diabetes-related burden.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

AID systems have become the preferred treatment for T1D, improving glycemic control, reducing hypoglycemia, and decreasing treatment burden compared with conventional insulin therapy. Both C-AID and OS-AID systems have demonstrated substantial clinical benefits, including increased time in range and improved patient-reported outcomes. However, despite their growing adoption, few randomized controlled trials have directly compared these systems under standardized conditions.

One of the major remaining challenges for current AID systems is the management of meals. Most commercially available systems are hybrid closed-loop systems that require users to announce meals and estimate carbohydrate intake before eating. Inaccurate carbohydrate estimation, delayed boluses, or missed meal announcements are common in daily life and contribute substantially to postprandial hyperglycemia and overall treatment burden. Although AID algorithms can partially compensate for these situations through automated insulin adjustments, their effectiveness varies between systems and has not been directly compared under real-world conditions.

This study aims to compare the performance of open-source and commercial AID systems during standardized unannounced meal challenges performed under free-living conditions. Adults with T1D who are experienced users of an OS-AID system will participate in a randomized, open-label, crossover trial in which they will use both their usual OS-AID system and a commercially available AID system. Throughout the study, participants will use the same Dexcom continuous glucose monitoring system to ensure consistent glucose assessment across study periods.

The primary objective is to determine whether OS-AID is non-inferior to commercial AID for maintaining postprandial glucose control following unannounced meals, as measured by the percentage of time spent in the target glucose range during the 4 hours after meal initiation. Secondary objectives include comparing overall glycemic outcomes, glucose variability, insulin delivery characteristics, and patient-reported outcomes related to treatment satisfaction, diabetes burden, and usability. The study will also explore differences in insulin dosing behavior, including user-initiated boluses, between the two AID approaches.

By evaluating glycemic performance in a common real-world scenario where meal announcements are omitted, this study will provide evidence regarding the comparative effectiveness, safety, and user experience of open-source and commercial AID systems. The findings are expected to inform clinical decision-making, support individualized selection of AID systems, and contribute to the development of future automated insulin delivery technologies that further reduce the burden of diabetes self-management.

研究の種類

介入

入学 (推定)

33

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

  • カナダ
    • Quebec
      • Montreal、Quebec、カナダ、H2H 1Y8
        • Institut de recherches cliniques de Montréal
        • コンタクト：
        • 主任研究者：
          • Rémi Rabasa-Lhoret, M.D. Ph.D

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

  • 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:

  • Males and females ≥ 18 years old currently residing in Canada or the United States of America (USA)
  • Having a clinical diagnosis of T1D for at least one year (based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
  • Having been on OS-AID therapy for at least 2 weeks and using a Dexcom G6 or G7 CGM.
  • If using an ultra-rapid acting insulin, be willing to switch to a rapid-acting insulin, as the former are not recommended in the C-AID systems used in the study (due to the risk of cannula or pod blockage).
  • Accepting that personal pump setting parameters will be collected by the research team. This access will be limited to the study period.

Exclusion Criteria:

  • Using regular insulin (Novolin ge Toronto or Humulin R) or U200 or U500 concentrated insulin (e.g. Humalog U200, Entuzity U500)
  • Participant-reported clinically significant nephropathy (eGFR < 25 ml/min/1.73m2, planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator
  • Recent (<3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
  • Anticipated therapeutic change (including change of CGM sensor [other than Dexcom sensors] or AID system type, new antidiabetic drug initiation) between admission and end of the study
  • % of time spent out of automated mode exceeding 10% in last month's trial start
  • Anticipated need to use hydroxyurea during the study period (as it can interfere with CGM readings)
  • Pregnancy (ongoing or current attempt to become pregnant)
  • Breastfeeding
  • Plan to go abroad in a foreign country during the study period
  • Severe hypoglycemic episode within one month of screening
  • Severe hyperglycemic episode (including DKA) requiring hospitalization in the last 3 months
  • Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)
  • Current use of SGLT-2 inhibitors or GLP1 agonists or other antidiabetic agents (Metformin, DPP-4 inhibitors) unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed (for iSGLT2 treatment).
  • Known or suspected allergies to study products (e.g., Dexcom adhesive)
  • Other serious medical illnesses likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator
  • Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change)
  • Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI)
  • In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device.

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：OS-AID
Participants will use their own OS-AID system, including Loop, AndroidAPS, or OpenAPS, together with their usual compatible insulin pump and a Dexcom G6 or Dexcom G7 continuous glucose monitoring (CGM) system. During the data collection phase, participants will complete two standardized unannounced meal challenges under free-living conditions. CGM and insulin pump data will be collected throughout the intervention period.
デバイス：Open-Source Automated Insulin Delivery (OS-AID)
Participants will use their own OS-AID system, including Loop, AndroidAPS, or OpenAPS, in combination with a compatible insulin pump and Dexcom G6 or Dexcom G7 continuous glucose monitoring (CGM). These systems use open-source algorithms to automatically adjust insulin delivery based on real-time CGM data through adaptive basal insulin modulation and, depending on the platform, automated correction boluses. Participants will continue using their established OS-AID settings throughout the intervention period without software updates and will be asked to perform two unannounced meal-challenges.
アクティブコンパレータ：Commercial-AID
Participants will use a C-AID system compatible with Dexcom CGM, including Tandem t X2 with Control-IQ or Omnipod 5, depending on their device and study allocation. Participants will receive study-provided equipment and training. During the data collection phase, participants will complete two standardized unannounced meal challenges under free-living conditions. CGM and insulin pump data will be collected throughout the intervention period.
デバイス：Commercial Automated Insulin Delivery (C-AID)
Participants will use a commercially available hybrid closed-loop AID system compatible with Dexcom G6 or Dexcom G7 CGM. Depending on study allocation and participants' usual device, the commercial system will include Tandem t X2 with Control-IQ technology or Omnipod 5. Participants not already using a compatible commercial AID system will receive study equipment and standardized training before initiating the intervention. Commercial AID systems automatically adjust insulin delivery based on continuous glucose measurements using manufacturer-specific algorithms while continuing to recommend user-initiated meal announcements and boluses for optimal performance.

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
Percentage of time in target glucose range during the 4 hours following unannounced meal challenges
時間枠：During the final 2 weeks of each 4-week intervention period (following the run-in phase).
Percentage of time with sensor glucose between 3.9 and 10.0 mmol/L (70-180 mg/dL) during the 4 hours following standardized unannounced meal challenges, measured using continuous glucose monitoring (CGM). Data will be analyzed at the meal level using all meal challenges completed during each intervention period.
During the final 2 weeks of each 4-week intervention period (following the run-in phase).

二次結果の測定

結果測定
メジャーの説明
時間枠
Time in tight range
時間枠：Final 2 weeks of each intervention period.
Percentage of time with sensor glucose between 3.9 and 7.8 mmol/L (70-140 mg/dL), measured by CGM.
Final 2 weeks of each intervention period.
Time Above Range (>10 mmol/L)
時間枠：Final 2 weeks of each intervention period.
Percentage of time with sensor glucose >10.0 mmol/L (>180 mg/dL), measured by CGM.
Final 2 weeks of each intervention period.
Time Above Range (>13.9 mmol/L)
時間枠：Final 2 weeks of each intervention period.
Percentage of time with sensor glucose >13.9 mmol/L (>250 mg/dL), measured by CGM.
Final 2 weeks of each intervention period.
Mean Glucose
時間枠：Final 2 weeks of each intervention period
Mean sensor glucose concentration (mmol/L) measured using CGM.
Final 2 weeks of each intervention period

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

Institut de Recherches Cliniques de Montreal

協力者

University of Alberta
Stanford University

捜査官

  • 主任研究者：Rémi Rabasa-Lhoret, M.D. Ph.D、IRCM

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 (推定)

2026年10月1日

一次修了 (推定)

2029年9月1日

研究の完了 (推定)

2029年12月31日

試験登録日

最初に提出

2026年8月6日

QC基準を満たした最初の提出物

2026年8月6日

最初の投稿 (実際)

2026年8月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月11日

QC基準を満たした最後の更新が送信されました

2026年8月6日

最終確認日

2026年8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

  • NOMAD

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

IPD プランの説明

Due to ethical and regulatory constraints, individual participant data generated in this study will not be made available to other researchers. Study results will be made publicly available through peer-reviewed publications and sharing with people living with T1D and caregivers: webinar, Better website, etc.

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

いいえ

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。

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