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Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis (PRECISE DM DX) 45 観察研究 個別化医療

募集準備中
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治験番号 NCT07111416 (PRECISE DM DX) は 観察研究 臨床試験 で、2型糖尿病 に関するものです。現在は 募集準備中 で、2025年9月1日 に開始予定です。45 名の参加者 の募集が計画されています。この試験は ブリガム・アンド・ウィメンズ病院 によって主導され、2026年5月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年8月8日 です。
概要
The goal of this observational study is to learn why some adults over the age of 65, have A1c tests that do not match up with their blood glucose levels, also known as 'A1c-glucose discordance'.

The main question it aims to answer is:

Could alternative tests like CGM or personalized A1c provide more accurate diabetes screening in this population?

Participants will be asked to perform blood tests every week to two ...

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Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis (PRECISE DM Dx)

疾患名
2型糖尿病
その他の研究識別子
  • PRECISE DM DX
  • 2025P001596
NCT番号
NCT07111416
開始日
2025-09-01
最終更新日
2025-08-08
終了予定日
2026-05-01
目標参加者数
45
試験の種類
観察研究
状況
募集準備中
主要評価項目
評価指標指標の説明時間枠
Calculate the Mean Absolute Difference Between A1c-Derived Estimated Average Glucose (eAG) and CGM-Derived eAG
Determine the mean absolute difference between estimated average glucose (eAG) calculated from hemoglobin A1c and eAG derived from Continuous Glucose Monitoring (CGM) data. This measure will be assessed among participants suspected of having discordance between A1c values and actual blood glucose levels.
From 1 week after enrollment to the end of their enrollment at either week 5 or week 10
参加アシスタント
適格基準

対象年齢
高齢者
試験の最低年齢
65 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  • Age 65 years of age or older
  • A1c 5.3% - 7.4% without a diagnosis on the problem list and/or current or prior treatment for diabetes
  • Evidence of A1c discordance by meeting one of two criteria developed by an EHR based algorithm
  • At least five (5) HbA1c values and three (3) CBC values available in the EHR in the previous 10 years
  • Willingness to wear an Abbott Freestyle Libre 3 System Sensor for up to 48 days
  • Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities

  • Known or suspected diabetes of other causes (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)

  • Clinically significant anemia based on most recent hematocrit (M = <38%, F <33%) and/or hemoglobin (M = <12 g/dL, F = <10 g/dL) within the last 12 months

  • Condition with short life expectancy

  • Blood (hematologic) malignancy

  • rtCGM-interference agents per manufacturer (e.g., high dose vitamin C)

  • Unstable psychiatric or medical condition

  • Active treatment for cancer, planned treatment for cancer, or recent active cancer with a likelihood of recurrence or progression, that, in the opinion of the site investigator, would interfere with study therapy prior to 2029

    • Allowed Exceptions: Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy. Examples of allowable cancers include:

      • Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy
      • Prostate cancer being observed
      • Stage 0 or 1 tumors status post resection or other definitive treatment
      • Other similarly stable cancer comorbidities
Brigham and Women's Hospital logoブリガム・アンド・ウィメンズ病院398 件のアクティブな治験を探索
責任者
Marie McDonnell, 主任研究者, Associate Professor, Brigham and Women's Hospital
連絡先情報がありません。