JP2020507166A - 遡及的な仮想基礎レートを用いて、インスリン送達を制御するための方法、システム、およびコンピュータ読み取り可能な媒体 - Google Patents
遡及的な仮想基礎レートを用いて、インスリン送達を制御するための方法、システム、およびコンピュータ読み取り可能な媒体 Download PDFInfo
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- A61M2205/00—General characteristics of the apparatus
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Abstract
Description
本出願は、2017年2月3日に出願された米国仮出願第62/454,282号の35 U.S.C. 119(e)およびPCT第8条下での利益を主張する。
図13に示すように、食事時の補正ボーラスアルゴリズムは、次のように考案された。患者が離散時間κにおける最適な補正ボーラスに関するアドバイスに興味があると仮定する。アルゴリズムの第1のステップは、CGM/SMBG測定と、最大κまでの患者の仮想基礎偏差uLAの比率とに基づいて、患者の代謝状態の推定値
一貫した毎日の注入パターン(1日の異なる時間に複数回注入する場合を含む)に基づいて、システム(および関連システム)は、
・インスリンのPK特性を用いて、24時間の周期にわたって血漿インスリン濃度の制限的な連続パターンを推論し、その後、
・CSIIを介して送達される速効型インスリンのPK特性を用いて、24時間の周期にわたって血漿インスリン濃度の同一パターンをもたらす持続的なCSII基礎レートプロファイルを決定する。
図1を再度参照すると、(投与のタイミングおよび投与量を含み、数日にわたる注入の漏れの可能性を勘案する)インスリン注入104の履歴記録に基づいて、サブシステム105は、以下のように遡及的な仮想基礎レート106を構築する。
・インスリンのPK特性を用いて、経時的注入から生じる血漿インスリン濃度を推論し、その後、
・CSIIを介して送達された速効型インスリンのPK特性を用いて、24時間の周期にわたって血漿インスリン濃度の同一の履歴濃度をもたらす持続的なCSII基礎レートプロファイルを決定する。
1.一定期間にわたって、実際のインスリン注入の記録
Claims (21)
- 患者にインスリンを送達するためのシステムであって、
前記患者から血糖測定値を受信するための少なくとも1つの入力装置と、
前記患者に送達されたインスリン量の履歴記録、および少なくとも1つの受信された血糖測定値から決定された遡及的な仮想基礎レートによるインスリン投与量に基づいて、前記患者に投与するインスリン量を計算するように構成されたプロセッサと、を含むグルコメータと、
前記計算された量のインスリンを前記患者に投与するように構成された、前記グルコメータと通信するインスリン送達装置と、を含むシステム。 - 前記少なくとも1つの入力装置が、前記患者からの血糖自己測定(SMBG)の測定値を受信する、請求項1に記載のシステム。
- 前記少なくとも1つの入力装置が、前記患者からの持続グルコースモニタ(CGM)の測定値を受信する、請求項1に記載のシステム。
- 前記遡及的な仮想基礎レートは、前記患者に送達されたインスリン量の履歴記録と共に、インスリンの薬物動態特性の数学的モデルから推論された血漿インスリン濃度パターンを、持続注入ポンプにより送達される速効型インスリンの薬物動態特性の数学的モデルから推論された基礎レートのインスリン送達の仮想記録に一致させることにより得られる、請求項1に記載のシステム。
- 前記患者に送達されたインスリン量の履歴記録は、以下のように得られ、
- 前記基礎レートのインスリン送達の仮想記録は、
- 前記血漿インスリン濃度パターンは、以下のように得られ、
- 前記プロセッサは、持続注入ポンプによって送達された速効型インスリンの薬物動態特性の数学的モデルから推論された基礎インスリン注入パターンに対して、所定のインスリン送達計画と共にインスリンの薬物動態特性の数学的モデルから推論された定常状態の血漿インスリン濃度から決定された仮想基礎レートプロファイルに基づいて、前記患者に投与するインスリン量を計算するようにさらに構成される、請求項6に記載のシステム。
- 前記初期の血漿インスリン濃度I(0)は、前記定常状態の血漿インスリン濃度から推定される、請求項8に記載のシステム。
- 皮下の持続グルコースモニタ(CGM)センサをさらに含み、前記グルコメータが、前記CGMセンサと無線通信する、請求項1に記載のシステム。
- 前記インスリン送達装置は、ユーザによって手動で作動する携帯用注入装置である、請求項1に記載のシステム。
- 患者にインスリンを送達する方法であって、
少なくとも1つのプロセッサにより、前記患者からの血糖測定値を受信するステップと、
少なくとも1つのプロセッサにより、前記患者に送達されたインスリン量の履歴記録、および少なくとも1つの受信された血糖測定値から決定された遡及的な仮想基礎レートによるインスリン投与量に基づいて、前記患者に投与するインスリン量を計算するステップと、
前記計算されたインスリン量を前記患者に投与するステップと、を含む方法。 - 前記血糖測定値は、前記患者からの血糖自己測定(SMBG)の測定値を含む、請求項12に記載の方法。
- 前記血糖測定値は、前記患者からの持続グルコースモニタ(CGM)の測定値を含む、請求項12に記載の方法。
- 前記遡及的な仮想基礎レートは、前記患者に送達されたインスリン量の前記履歴記録と共に、インスリンの薬物動態特性の数学的モデルから推論された血漿インスリン濃度パターンを、持続注入ポンプにより送達された速効型インスリンの薬物動態特性の数学的モデルから推論された基礎レートのインスリン送達の仮想記録に一致させることにより得られる、請求項12に記載の方法。
- 前記患者に送達されたインスリン量の前記履歴記録は、以下のように得られ、
- 前記基礎レートのインスリン送達の仮想記録は、
- 前記血漿インスリン濃度パターンは、以下のように得られ、
- 持続注入ポンプによって送達された速効型インスリンの薬物動態特性の数学的モデルから推論された基礎インスリン注入パターンに対して、所定のインスリン送達計画と共にインスリンの薬物動態特性の数学的モデルから推論された定常状態の血漿インスリン濃度から決定された仮想基礎レートプロファイルに基づいて、前記患者に投与するインスリン量を計算するステップをさらに含む、請求項17に記載の方法。
- 前記初期の血漿インスリン濃度I(0)は、前記定常状態の血漿インスリン濃度から推定される、請求項19に記載の方法。
- 前記計算された量のインスリンが、ユーザによって手動で作動する携帯用注入装置を用いて前記患者に投与される、請求項12に記載の方法。
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CA3052457C (en) | 2021-08-24 |
CN110402156A (zh) | 2019-11-01 |
CN110402156B (zh) | 2022-05-03 |
CN114796704B (zh) | 2024-04-12 |
CA3052457A1 (en) | 2018-08-09 |
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