Continuous Glucose Monitoring for In-hospital Management of Type 2 Diabetes
Continuous Glucose Monitoring vs Point of Care Glucose Measurements for In-hospital Type 2 Diabetes Management - STENO In-Hospital CGM Trial - a Multisite, Randomized Controlled Trial.
Title: Continuous glucose monitoring vs point of care glucose measurements for in-hospital type 2 diabetes management - STENO In-Hospital CGM Trial - a multisite, randomized controlled trial.
Aim To investigate the effects and feasibility of continuous glucose monitoring (CGM) on in-hospital glycemic and clinical outcomes in hospitalized, non-intensive care unit (non-ICU) patients with type 2 diabetes compared to standard point-of-care (POC) glucose testing.
Population: Non-ICU adults with type 2 diabetes at the participating departments at hospitals in the Capital Region of Denmark.
Design: Investigator-initiated, multi-site, two-armed, prospective, randomized, open-labelled blinded endpoint (PROBE) trial. Participants are randomized 1:1 to either a POC-arm (control) or a CGM-arm (intervention):
- POC-arm (control): Participants in this arm are monitored with standard of care POC-based glucose monitoring and treated with insulin according to national guidelines. Blinded CGM is applied.
- CGM-arm (intervention): Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration.
In the CGM-arm, a diabetes support team assists in insulin titration to ensure the execution of algorithmic decisions according to protocol. In the POC-arm the same diabetes support team will ensure that participants are treated with insulin according to national guidelines.
Objectives: To compare in-hospital glycemic control and clinical outcomes between the POC- and CGM-arm participants.
Outcomes: Time in range (3.9-10.0 mmol/L) and in-hospital complications are the primary outcomes. Additional secondary glycemic outcomes are reported in alignment with the newest consensus on CGM-metrics for in-hospital glucose management. Key secondary clinical outcomes are length of stay, 7-, 30-, 60-, and 90-days mortality and readmission rates after discharge. Tertiary outcomes are net costs of the two methods for handling in-hospital diabetes, and an assessment of potential heterogeneity of treatment effects from CGM compared to POC.
Method: POC glucose measurements are transmitted to the Electronic Medical Record (Sundhedsplatformen). CGM data from the Dexcom G7 is transmitted to a separate web-based platform, Dexcom CLARITY, for retrospective review. Additionally, real-time glucose data from the Dexcom G7 is displayed on tablets/iPhones at diabetes support team stations for ongoing monitoring.
Investigational device: Dexcom G7 CGM (Dexcom Inc., San Diego, USA). Time schedule: Inclusion Q2 2025 to Q4 2026.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
参加基準
適格基準
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
説明
Inclusion Criteria:
Type 2 diabetes defined as treatment with at least one glucose-lowering therapy prior to inclusion AND
- age ≥ 18 years old AND
- willingness and ability to comply with the trial protocol AND
- ability to communicate (in Danish or English) with the trial personnel AND
- an expected length of hospital stay for at least two days after enrolment.
Exclusion Criteria:
- Known hypersensitivity to the band-aid of the CGM Dexcom G7 sensor OR
- Pregnancy OR
- Patients admitted with diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) OR
- Concomitant treatment with hydroxyurea (CGM contraindication) OR
- Treatment with enteral or parenteral nutrition.
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）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
介入なし：POC-arm
|
|
|
実験的：CGM-arm
|
Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration.
|
この研究は何を測定していますか？
主要な結果の測定
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 spent in range (3.9-10.0 mmol/L)
時間枠：From enrollment to end of hospitalization.
|
Primary outcome measures are collected from the day of inclusion (hospitalization) of a participant until the day the participant is discharged from the hospital.
The duration of the hospitalization varies for each participant and will rarely exceed 30 days.
|
From enrollment to end of hospitalization.
|
|
Inhospital complications
時間枠：From enrollment to end of hospitalization.
|
Primary outcome measures are collected from the day of inclusion (hospitalization) of a participant until the day the participant is discharged from the hospital.
The duration of the hospitalization varies for each participant and will rarely exceed 30 days.
|
From enrollment to end of hospitalization.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 2500766
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?
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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