Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes (SMILE)
A premarket, international multicenter, prospective, open label, adaptive, randomized controlled study.
The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and HbA1c.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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London、イギリス、SE5 9NU
- King's College London
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Manchester、イギリス
- Manchester Diabetes Center
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N. Yorkshire
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Harrogate、N. Yorkshire、イギリス、HG2 7SX
- Harrogate District Hospital
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Bergamo、イタリア
- Ospedale Papa Giovanni Xxiii
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Milan、イタリア
- Ospedale S. Raffaele
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Olbia、イタリア
- Ospedale S. Gionanni di Dio
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Gouda、オランダ
- Groene Hart Ziekenhuis
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Rotterdam、オランダ
- Maasstad ziekenhuis
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Utrecht、オランダ
- UMC Utrecht
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Zwolle、オランダ
- Isala
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Besançon、フランス
- CHU de Besançon
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Grenoble、フランス
- Chu Grenoble
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Marseille、フランス
- APHM - La Conception
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Montpellier、フランス
- CHU Montpellier - Hôpital Lapeyronie
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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:
- Age 24-75 years old at time of screening.
- Diagnosed with Type 1 diabetes ≥10 years prior to screening.
- On pump therapy for ≥ 6 months prior to screening.
- Not on Real Time continuous glucose monitoring for ≥ 3 months prior to screening.
- HbA1c value ≥5.8% and ≤10.0% as assessed by local lab ≤ 15 days prior to screening or performed at screening.
- A documented Severe Hypoglycemia event ≤ 12 months prior to screening, OR Clarke score ≥4 assessed at time of screening, OR
- Gold score ≥4 assessed at time of screening.
- Subject is willing to sign and date informed consent, comply with all study procedures and wear all study devices as required during the study.
Exclusion Criteria:
- Untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
- Subject is using Pramlintide (Symlin) SGLT2 inhibitor, GLP agonist at time of screening.
- Renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 3 months before screening or performed at screening at local lab.
- Hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
- Current pregnancy or intention to conceive.
- Any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection).
- Alcohol or drug abuse, other than nicotine, per investigator judgment.
- Any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
- Legally incompetent, illiterate or vulnerable person.
Randomization Criteria:
If subjects meet the above criteria, as well as all of the following criteria assessed at the end of the run-in period, they may continue to participate in the treatment period of the study:
- Subject has worn two weeks the sensor with transmitter during the run-in period.
- Subject has shown acceptable tolerance of sensor wear, per investigator judgment.
- Subject performed ≥ 4 finger stick blood glucose measurements daily, as determined by CareLink™ Clinical data upload as the mean number of SMBG/day over the past 14 days (SMBG number / day ≥ 3.5 rounds up to 4).
- Subject showed ability to comprehend the pump training and study procedures, per investigator judgment.
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 |
|---|---|
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実験的：Treatment
MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on.
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All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON. Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase.
他の名前：
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アクティブコンパレータ：Control
MiniMed™640G alone
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Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.
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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 |
時間枠 |
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Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
時間枠：6 months
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6 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
時間枠：6 months
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6 months
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Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.
時間枠：6 months
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6 months
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Habteab A, Castaneda J, de Valk H, Choudhary P, Bosi E, Lablanche S, de Portu S, Da Silva J, Vorrink-de Groot L, Shin J, Cohen O. Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial. Diabetes Technol Ther. 2020 Sep;22(9):681-685. doi: 10.1089/dia.2019.0495.
- Bosi E, Choudhary P, de Valk HW, Lablanche S, Castaneda J, de Portu S, Da Silva J, Re R, Vorrink-de Groot L, Shin J, Kaufman FR, Cohen O; SMILE Study Group. Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial. Lancet Diabetes Endocrinol. 2019 Jun;7(6):462-472. doi: 10.1016/S2213-8587(19)30150-0. Epub 2019 Apr 29.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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。