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治験 NCT03764280（対象：糖尿病、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。 | ||
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マギル大学The Efficacy of MDI Treatment With an Optimization Algorithm Adjusting Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp 21 思春期
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 NCT03764280 は 介入研究 臨床試験 で、糖尿病、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7月2日 に開始し、21 名の参加者 が参加しました。この試験は マギル大学 によって主導され、2018年8月10日 に完了しました。ClinicalTrials.gov からの最新更新日は 2019年8月15日 です。
概要
Our lab at McGill University has developed an optimization algorithm for T1D MDI patients that estimates optimal basal-bolus parameters (basal injections and insulin-to-carbohydrate ratios) using glucose sensor data and insulin dosing data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal injections and ICRs. The investigators hope that this algorithm w...もっと見る
詳細説明
The objective of this project is to compare our basal-bolus optimization algorithm with physician adjusted basal-bolus parameters using a randomized parallel clinical trial in children and adolescents at a Camp Carowanis. The investigators hypothesize that using this optimization algorithm will be non-inferior to the physician-adjusted basal-bolus parameters regarding time spent in target glucose range (3.9 mmol/L - ...もっと見る
公式タイトル
An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Efficacy of MDI Treatment With Physician Adjusted and Optimization Algorithm Adjusted Basal-Bolus Parameters in Children and Adolescents With Type 1 Diabetes at a Diabetes Camp
疾患名
糖尿病1型糖尿病その他の研究識別子
- MDI Optimization Algorithm
NCT番号
開始日
2018-07-02
最終更新日
2019-08-15
終了予定日
2018-08-10
目標参加者数
21
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
Multiple Daily Injections
type 1 diabetes
pediatrics
optimization algorithm
type 1 diabetes
pediatrics
optimization algorithm
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
非介入MDI with Physician Adjusted Basal-Bolus Parameters Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Participants will undergo their conventional multiple daily injection (MDI) therapy. | 該当なし |
実験的MDI with Basal-Bolus Optimization Algorithm Participants will be wearing the Freestyle Libre glucose sensor (Abbott Diabetes Care). Once daily, the data from the glucose sensor and injection information will be entered into a computer and the optimization algorithm will be run. Once daily, participants' parameters may be changed based on the algorithm's recommendations. | Multiple Daily Injections: Slow acting insulin and Rapid acting insulin Multiple daily injections (MDI) therapy involves four or more daily insulin injections. Once or twice daily, a long acting insulin is injected as a basal dose. These long acting insulins are designed to dissipate slowly and evenly into the bloodstream for 24 to 36 hours following injection. This basal injection aims to mimic the physiological healthy basal insulin released from a healthy pancreas all day. Furthermore...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of time of sensor glucose levels spent in target range (defined to be between 3.9 mmol/L and 10.0 mmol/L). | the last 7 days of the study. |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Percentage of time of sensor glucose levels spent: | a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L. | last 7 days of the study |
Percentage of overnight time (23:00-7:00) of sensor glucose levels | a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L. | last 7 days of the study |
Percentage of daytime (7:00-23:00) of sensor glucose levels | a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L. | last 7 days of the study |
Standard deviation of glucose levels as a measure of glucose variability | last 7 days of the study | |
Total insulin delivery. | last 7 days | |
Mean sensor glucose level during | a. the overall study period; b. the daytime period; c. overnight period. | last 7 days |
Number of participants experiencing hypoglycemia requiring oral treatment during | a. the overall study period; b. the daytime period; c. overnight period. | last 7 days |
適格基準
対象年齢
小児, 成人
試験の最低年齢
8 Years
対象性別
全て
- Males and females between 8 and 18 years old.
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Undergoing multiple daily injection therapy.
- HbA1c ≤ 11%.
- Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with the study protocol or with team's recommendations.
- Injection of isophane insulin (NPH) or any intermediate-acting insulin
- More than one injection of slow-acting insulin per day.
マギル大学239 件のアクティブな治験を探索連絡先情報がありません。
1 1カ国の場所
Quebec
Camp Carowanis, Sainte-Agathe-des-Monts, Quebec, J8C 2Z7, Canada