糖尿病を有する患者における新しいメドトロニック実験的オートメーションインスリン送達システム（NMX8）の安全性と性能の評価（NEXUS） (NEXUS)
糖尿病患者における新型メドトロニック実験的自動インスリン送達システム（NMX8）の安全性と性能の評価
This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.
調査の概要
詳細な説明
This study is a pre-market, interventional, prospective, open-label, multi-center and randomized controlled clinical study.
The study consists of a run-in phase and a study phase.
Run-in Phase:
The purpose of the run-in phase is to collect baseline CGM data while subjects are on 780G therapy in Auto Mode. All subjects will use the Simplera Sync sensor.
At the end of the run-in phase, subjects will be randomly allocated to one of the two study arms (Treatment arm or Control arm).
Study Phase:
During the 12-week study phase, subjects will either start using the MiniMed™ NMX8 system (Treatment arm) or will continue to use the MiniMed™ 780G in Auto Mode (Control arm). During the study phase, all subjects will use the Simplera™ Sync sensor.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Renée Tillie, PhD
- 電話番号：+31627363854
- メール：renee.tillie@medtronic.com
研究連絡先のバックアップ
- 名前：Bérangère Lacroix
- 電話番号：+41797187595
- メール：berangere.lacroix@medtronic.com
研究場所
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Ramat Gan、イスラエル
- 募集
- Sheba Medical Center, Edmond and Lily Safra Children's Hospital
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主任研究者：
- Noah Gruber
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Ramat Gan、イスラエル
- 募集
- Sheba Medical Center
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主任研究者：
- Amir Tirosh
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Ljubljana、スロベニア
- 募集
- University Medical Centre Ljubljana
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主任研究者：
- Klemen Dovc
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Aarhus、デンマーク
- 募集
- Steno Diabetes Center Aarhus
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主任研究者：
- Rakel Fuglsang Johansen
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Herlev、デンマーク
- 募集
- Steno Diabetes Center Copenhagen
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主任研究者：
- Kirsten Noergaard
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Antwerp、ベルギー
- 募集
- Universitair Ziekenhuis Antwerpen
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主任研究者：
- Christophe De Block
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Brussels、ベルギー
- 募集
- Cliniques Universitaires de Bruxelles - Hôpital Erasme
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主任研究者：
- Laurent Crenier
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Leuven、ベルギー
- 募集
- UZ Leuven
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主任研究者：
- Kristina Casteels
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主任研究者：
- Pieter Gillard
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Is aged ≥2 years old at time of screening.
- Has a clinical diagnosis of Type 1 or Type 2 diabetes for ≥ 6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.
- Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.
- Has a glycosylated hemoglobin (HbA1c) <11% (97 mmol/mol) at time of screening visit as processed at Point of Care (PoC) or local lab.
- Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units
- Willing to switch to approved insulin per insulin pump labeling.
- Investigator has confidence that the subject, parent(s)/legal guardian(s) can successfully operate all study devices and is capable of adhering to study visit schedule per protocol.
- Subject, Parent(s)/legal guardian(s) is willing to participate in all training sessions as directed by study staff.
- Subject, Parent(s)/legal guardian(s) is willing and able to provide written informed consent.
- For subject with Type 2 Diabetes only: Is on stable dose of anti-diabetic medication (other than insulin) (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors) for the last 3 months prior to screening. NB: Subject should not change type or dose of medication during the course of the study.
- For Israel only: Subject, Parents(s)/legal guardian(s) is fluent in English.
Exclusion Criteria:
- Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.
- For subjects with Type 1 Diabetes only: Is using any anti-diabetic medication other than insulin 6 months before screening or plan on using during the study (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists/mimetics, metformin, SGLT2 inhibitors).
- Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any chronically oral, injectable, or IV glucocorticoids during the course of the study, per investigator judgement
- Has had renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.
- Has active or severe retinopathy in the last 6 months before screening
- Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
- Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- History of 2 or more DKA events in the last 3 months before screening.
- Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.
- Is using hydroxyurea at time of screening or plans to use it during the study
- Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.
- Women who are breastfeeding.
- Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before screening, as per investigator judgment.
- Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.
- Subject, Parent(s)/legal guardian(s) are part of research staff involved with the study.
- Subject, Parent(s)/legal guardian (s) are legally incompetent, illiterate, or vulnerable.
研究計画
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：並列代入
- 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 |
|---|---|
|
実験的：Treatment arm (NMX8)
Subjects randomized to the Treatment group will use the MiniMed™ NMX8 system |
Subjects will start using the MiniMed™ NMX8 system for 12 weeks |
|
アクティブコンパレータ：Control arm (780G)
Subjects randomized to the Control arm will continue to use the MiniMed™ 780G. |
Subjects will continue to use the MiniMed™ 780G for 12 weeks |
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 |
|---|---|---|
|
Primary Endpoint
時間枠：During the 12-week study phase
|
The between-treatment (control arm with 780G system versus treatment arm with NMX8 system) difference during the study phase in the percentage of time that the sensor glucose measurement is in the target range, 70 to 180 mg/dL (3.9-10.0 mmol/L) with a non-inferiority testing. |
During the 12-week study phase
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Secondary Endpoint 1
時間枠：End of 12-week Study Phase
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The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with a non-inferiority testing. |
End of 12-week Study Phase
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Secondary endpoint 2
時間枠：During the 12-week Study Phase
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The between-treatment (NMX8 system arm versus 780Gm system arm) difference in % of Time spent in target range (70 to 180 mg/dL [3.9 - 10.0 mmol/L]) during the study phase with superiority test. |
During the 12-week Study Phase
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Secondary Endpoint 3
時間枠：End of the 12-week Study Phase
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The between-treatment (NMX8 system arm versus 780Gm system arm) difference in HbA1c (%) at the end of the 3-month study phase with superiority testing. |
End of the 12-week Study Phase
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Pr. Ohad Cohen, MD、Medtronic MiniMed, Inc.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。