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Effect of FGM on Glucose Control in Diabetic Patients 600

状況不明
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT03785301 は 介入研究 臨床試験 で、糖尿病 に関するものです。現在は 状況不明 で、2018年12月20日 から開始しています。600 名の参加者 の募集が計画されています。この試験は Nanjing First Hospital, Nanjing Medical University によって主導され、2019年12月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2019年6月11日 です。
概要
The aim of the study is to assess the effect of FGM on glycemic control compared with SMBG using a randomised controlled study design in adults with type 2 diabetes.
詳細説明
Flash glucose monitoring (FGM) is a newly introduced Glucose Monitoring system. The aim of the study is to assess the effect of FGM on glycemic control compared with standard blood glucose monitoring (SMBG) using a randomised controlled study design in adults with type 2 diabetes. Subjects will use unmasked FGM once a month or SMBG to monitor glucose level for 3 months. Patients in the SMBG group will wear masked FGM ...もっと見る
公式タイトル

Effect of FGM on Glucose Control in Diabetic Patients

疾患名
糖尿病
刊行物
この臨床試験について発表された科学記事と研究論文：
その他の研究識別子
  • KY20170904-04
NCT番号
NCT03785301
開始日
2018-12-20
最終更新日
2019-06-11
終了予定日
2019-12-31
目標参加者数
600
試験の種類
介入研究
治験の相・段階
該当なし
状況
状況不明
主目的
その他
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的FGM group
Diabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months.
Freestyle Libre Flash Glucose Monitoring
Freestyle Libre Flash Glucose Monitoring will be used in diabetic patients once a month for therr months to monitor glucose level. Patients could scan the sensor to get the glucose level at any time as they want. They could alter thier diet and exercise according to the glucose levels. Patients will be required to keep track of food and exercise during wearing FGM sensor. Physicians would adjust patients' medication ...もっと見る
非介入SMBG group
Diabetic patients will use Standard Blood Glucose Monitoring (SMBG) to monitor glucose level for 3 months. A 14-day masked wear of FreeStyle Libre H Flash Glucose Monitoring system is included for these subjects once a month, to collect glycaemic variability data for comparison to the intervention group of the study.
該当なし
主要評価項目
評価指標指標の説明時間枠
HbA1c
Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c
3 months
副次評価項目
評価指標指標の説明時間枠
mean blood glucose (MBG)
Difference in HbA1c between intervention and control group at 1, 2, and 3 month.
1,2,3 months
coefficient of variation (CV)
Difference in CV between intervention and control group at 1, 2, and 3 month.
1,2,3 months
area under the curve (AUC)<3.9mmol/L and >10mmol/L
Difference in AUC\<3.9mmol/L and \>10mmol/L between intervention and control group at 1, 2, and 3 month.
1,2,3 months
Time in Range (TIR)
Difference in time in range 3.9-10 mmol/L between intervention and control group at 1, 2, and 3 month.
1,2,3 months
FGM accuracy
Accuracy of FGM values versus reference blood glucose values (Consensus Error Grid (CEG) analysis and calculation of the Mean Absolute Relative Difference (MARD)
during FGM
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  1. >18 years old;
  2. diagnosed as having diabetes who were willing to perform the study and complete the data collection;
  3. in stable condition prior to the study.

  1. pregnancy or attempting to conceive;
  2. known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin;
  3. skin lesions, scarring, redness, infection, or edema at the sensor application sites;
  4. patients whose conditions were extremely severe and not stable.
Nanjing First Hospital, Nanjing Medical University logoNanjing First Hospital, Nanjing Medical University
試験中央連絡先
連絡先: Ma Jianhua, MD, 8625-52887092, [email protected]
1 1カ国の場所

Jiangsu

Nanjing First Hostital, Nanjing, Jiangsu, 210000, China
Jianhua Ma, Doctor, 連絡先, +8618951670116, [email protected]
募集中