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治験 NCT03020069（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
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Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes 13 思春期 短期
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 NCT03020069 は 介入研究 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。2015年11月1日 に開始し、13 名の参加者 が参加しました。この試験は NYU Langone Health によって主導され、2018年7月13日 に完了しました。ClinicalTrials.gov からの最新更新日は 2020年3月16日 です。
概要
The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influe...もっと見る
詳細説明
Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c > = 8 % who are also naive to CGMS use will be recruited from the diabetes outpatient population followed at Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20 subjects will be assigned to the control group.
公式タイトル
Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes
疾患名
1型糖尿病その他の研究識別子
- 16-01011
NCT番号
開始日
2015-11
最終更新日
2020-03-16
終了予定日
2018-07-13
目標参加者数
13
試験の種類
介入研究
治験の相・段階
該当なし
状況
完了
キーワード
Type 1 Diabetes
Adolescents
Glucose Monitoring
Adolescents
Glucose Monitoring
主目的
診断
割付方法
非無作為化
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Glucose Meter Continuing Glucose Monitoring Device | CGMS Device |
実薬対照薬No Glucose Meter Average Blood glucose measure | No Device |
主要評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months | The PedsQL 3.2 Diabetes Module is composed of 33 items. Item scaling is a 5-point scale from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. The total score is calculated as the sum of all items over the number of items answered on all the scales (total score ranges from 0-3300). Higher scores indicate lower problems. The change in total score is calculated by subtracting the total score at baseline from the total score at 3 months. | Baseline, 3 Months |
Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months | HbA1c measurements will be measured in the lab at the location of the patient's visit at baseline and 3 months. The measured HbA1c level at 3 months will be subtracted from the measured level at baseline to calculate the change. | Baseline, 3 Months |
Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months | Blood sugar (glucose) will be measured via glucose monitors. The change in level of blood sugar will be calculated by subtracting the blood glucose level at 3 months from the blood glucose level at baseline. | Baseline, 3 Months |
Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months | There are 8 items that constitute the DES-SF. The scale is scored by averaging the scores of all completed items. 1 = strongly disagree and 5 = strongly agree. The change in score between baseline and 3 months will be calculated by subtracting the average score from 3 months from the baseline score. | Baseline, 3 months |
適格基準
対象年齢
小児, 成人
試験の最低年齢
13 Years
対象性別
全て
- type 1 diabetes
- HbA1c > = 8 %
- naive to CGMS use
- Patients with developmental delay
- Patients who do not use a glucose meter to test capillary blood glucose level
- Patients without access to a telephone will be excluded.
NYU Langone Health連絡先情報がありません。
1 1カ国の場所
New York
New York University Medical Center, New York, New York, 10016, United States