Smartguard Use in Real Life : a Longitudinal Study in Patients With Type 1 Diabetes (Smartguard)
The reference treatment of the type 1 diabetes is intensified insulin therapy by insulin pump. The CGM (continuous glucose monitoring) is a technology available for a decade, which allows the continuous measure of interstitial glucose rate. The results are available in real time to the user, who can so use them to optimize the adjustment of its treatment by insulin pump. Since a few years, several research programs aim for finalizing an automated system using the data of real time interstitial glucose to adjust automatically, via an algorithm, the release of insulin by the pump. This type of closed-loop system is for the moment only experimental, not still widely available in routine. On the other hand, rudimentary regulation systems partially automated already exist and can be used in common clinical practice. One of these systems, Smartguard ®, allows this type of regulation to decrease the hypoglycemic risk of the patients treated by insulin pump. It is indeed a hypo minimizer which interrupts the basal output when the algorithm embarked on the pump determines thanks to the CGM data what a hypoglycemia risks to occur in the 30 minutes. The efficiency of this system to reduce hypoglycemias was proved by several studies in pediatric and adult populations of subjects with DT1 (Diabetes Care on 2015; 38:1197-1204. J Diabetes Sci Technol. 2016 May 20. Pii: 1932296816645119). However, to date, there are no published data concerning the method of use of this system (sensor et pump initial configuration; patient education), nor the evolution of the sensor and pump parameters during the use.
The aim of this observationnelle study is to collect the data of efficiency, safety and use of the system Smartguard ® in common clinical practice in an adult population of subjects DT1.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Caen、フランス、14000
- Endocrinology Unit and Clinical Research Center Basse Normandie, University Hospital of Caen
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Type 1 diabetes ≥ 1 year
- CSII ≥ 6 months
- Previous education to flexible insulin therapy
- Patient willing to use sensors and smartguard option for 1 year
- A1c ≥ 7.5% and/or severe hypoglycemia ≥ 2 episodes during the last 6 month and/or recurrent hypoglycemia and/or hypoglycemia unawareness and/or brittle diabetes
Exclusion Criteria:
- No access to a computer and/or to the web making it impossible to follow patients through telemedicine
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
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 |
---|---|---|
Glucose TIR (time in range) from CGM recording
時間枠:change between baseline and after 12 month
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TIR will be calculated from the CGM recording, thanks to the medtronic carelink software
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change between baseline and after 12 month
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Glucose Time below range (hypoglycemia < 70 mg/dl) from CGM recording
時間枠:change between baseline and after 12 month
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Time below range will be calculated from the CGM recording, thanks to the medtronic carelink software
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change between baseline and after 12 month
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二次結果の測定
結果測定 |
時間枠 |
---|---|
HbA1c
時間枠:month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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その他の成果指標
結果測定 |
時間枠 |
---|---|
daily insulin total dose
時間枠:month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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basal / bolus ratio
時間枠:month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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daily bolus number
時間枠:month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Mean daily hypoglycemic predictive-stop time
時間枠:month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Mean daily hypoglycemic-stop time
時間枠:month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Time Percentage with CGM Sensor Use Time
時間枠:month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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Medical time at each consultation
時間枠:month 0, 3, 6, 9, 12
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month 0, 3, 6, 9, 12
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協力者と研究者
捜査官
- 主任研究者:Michael JOUBERT, MD、University Hospital, Caen
出版物と役立つリンク
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。