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治験 NCT03703999（対象：1型糖尿病）は完了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Freestyle Libre Use in Real Life: Efficacy and Acceptance 100
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 NCT03703999 は 観察研究 臨床試験 で、1型糖尿病 を対象とした研究でした。現在は 完了 です。2018年6月1日 に開始し、100 名の参加者 が参加しました。この試験は University of Padova によって主導され、2019年9月1日 に完了しました。ClinicalTrials.gov からの最新更新日は 2020年3月27日 です。
概要
Aim of the study is to evaluate efficacy of freestyle Libre system (flash glucose monitoring) in real life in term of Glycated Haemoglobin reduction and acceptance of the system evaluated through validated questionnaires after 3 and 6 months of device's use.
詳細説明
Freestyle Libre is a new technology developed to monitor glycemic values in diabetic patients.
The system is available in Italy from 2014 but in Veneto region reimbursement for insulin treated diabetic patients is available from august 2017.
International trial (for example Impact trial) demonstrated efficacy of the system (reduction of the time spent in hypoglycemia).
Aim of this study is to evaluate efficacy in ...
もっと見る公式タイトル
Efficacy and Acceptance of Freestyle Libre Abbott Use in Real Life in Type 1 Diabetic Patients
疾患名
1型糖尿病その他の研究識別子
- 4465/AO/18
NCT番号
開始日
2018-06-01
最終更新日
2020-03-27
終了予定日
2019-09-01
目標参加者数
100
試験の種類
観察研究
状況
完了
キーワード
flash glucose monitoring
HbA1c
HbA1c
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
type 1 diabetic patients freestyle Libre group of type 1 diabetic patients that will be selected to use Freestyle libre on the basis of clinicians decisions and reimbursement criteria | Type 1 diabetic patients freestyle libre patients selected to use freestyle libre |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
HbA1c | changes in HbA1c values | after 3 and 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
changes in hypoglycemia fear | Evaluation of hypoglycemia fear through a validated questionnaires, Hypoglycemic Fear Survey (HFS-II). The questionnaires is composed by 33 questions with a Linkert Scale (0-4) | after 3 and 6 months |
changes in therapy satisfaction | Evaluation of changes in therapy satisfaction through a validated questionnaires, Diabetes Treatment Satisfaction Questionnaire (DTSQ). The questionnaires is composed by 8 questions with a Linkert Scale (0-6) | after 3 and 6 months |
hypoglycemic episodes | number of hypoglycemic episodes | after 3 and 6 months |
weight | changes in weight (Kg) | after 3 and 6 months |
insulin use | changes in insulin dose (unit/Kg) | after 3 and 6 months |
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
- Male and female participants of at least 18 years of age
- Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year
- Availability to wear Freestyle Libre sensor
- Signature of informed consent
- Pregnancy, breastfeeding, intention to undergo pregnancy
- Known allergies to skin patches or disinfectants used during the study.
- Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement
- Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period.
- Severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while using freestyle LIbre sensor
- Patients enrolled in other clinical trials.
- patients that usually wear other continuous glucose monitoring system
University of Padova責任者
Daniela Bruttomesso, 主任研究者, MD, PhD, University of Padova
連絡先情報がありません。
1 1カ国の場所
University of Padova, Padova, Italy