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治験 NCT03545178 (SECOND)（対象：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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Systematic Evaluation of Continuous Glucose Monitoring Data (SECOND) 384
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 NCT03545178 (SECOND) は 観察研究 臨床試験 で、糖尿病 を対象とした研究でした。現在は 完了 です。2018年4月1日 に開始し、384 名の参加者 が参加しました。この試験は Insel Gruppe AG, University Hospital Bern によって主導され、2019年7月19日 に完了しました。ClinicalTrials.gov からの最新更新日は 2019年8月13日 です。
概要
This study retrospectively evaluates continuous glucose monitoring (CGM) and flash glucose monitoring (FGM) data and pursues two main objectives: First, the investigators analyze if glucose values are better controlled in the days directly before a consultation at our tertiary referral centre (so called "white coat adherence"). Second, the investigators use the collected CGM and FGM data to develop a hypoglycemia pre...もっと見る
詳細説明
Substudy A.) Presence of white coat adherence in diabetic patients:
The investigators aim at evaluating the existence of a so called "white coat adherence" with regard to diabetes control, which means that blood-glucose is better controlled in the days immediately prior to a consultation at the diabetes clinic compared to the time-period further back. To analyse this phenomenon, the investigators use continuous gluc...
もっと見る公式タイトル
Systematic Evaluation of Continuous Glucose Monitoring Data to for the Development of Clinical Solutions
疾患名
糖尿病その他の研究識別子
- SECOND
- 2018-00207
NCT番号
開始日
2018-04-01
最終更新日
2019-08-13
終了予定日
2019-07-19
目標参加者数
384
試験の種類
観察研究
状況
完了
キーワード
white coat adherence
continuous glucose monitoring
flash glucose monitoring
hypoglycemia prediction
deep learning algorithm
continuous glucose monitoring
flash glucose monitoring
hypoglycemia prediction
deep learning algorithm
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Diabetic patients using CGM/FGM Evaluation of glucose control and application of hypoglycemia prediction models in diabetic patients wearing CGM and/or FGM devices for at least 50% of the time during the last 4 weeks prior to the medical consultation. | glucose control (Substudy A) Comparison of glucose values during days 0 - 3 with days 4 - 28 and 0 - 7 with days 8 - 28 before a medical consultation at the diabetes clinic in patients suffering from diabetes and wearing a continuous glucose monitoring and/or flash glucose monitoring device hypoglycemia prediction (Substudy B) Use of CGM/FGM data to develop and evaluate a neural network based hypoglycemia prediction model |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change of time in target glucose range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | The time spent in the target glucose range from 3.9 to 10.0 mmol/l assessed by CGM/FGM. | 01.01.2013 - 31.07.2018; outcome assessed at study end |
Hypoglycemia prediction (for Substudy B) | Proportion of times a deep learning based algorithm can predict a hypoglycemic event (BG \<4.0 mmol/l) at least 20 min ahead in time? | 01.01.2013 - 31.07.2018; outcome assessed at study end |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change of time above and below glucose target range day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | The time spent above and below the target glucose (3.9 to 10.0 mmol/l) assessed by CGM/FGM. | 01.01.2013 - 31.07.2018; outcome assessed at study end |
Change of average and standard deviation glucose day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | Average and standard deviation glucose levels based on CGM/FGM data | 01.01.2013 - 31.07.2018; outcome assessed at study end |
Sensor wearing time day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | Time CGM-/FGM sensor has been worn (%) | 01.01.2013 - 31.07.2018; outcome assessed at study end |
Change of coefficient of variation (CV) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | Coefficient of variation (CV) based on CGM/FGM data | 01.01.2013 - 31.07.2018; outcome assessed at study end |
Change of time in hypoglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | The time with glucose levels \< 3.0 based on CGM/FGM data | 01.01.2013 - 31.07.2018; outcome assessed at study end |
Change of time in hyperglycemia day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | The time with glucose levels in the significant hyperglycaemia, as based on CGM/FGM (glucose levels \> 13.9 mmol/l) | 01.01.2013 - 31.07.2018; outcome assessed at study end |
Change of mean amplitude of glucose excursion (MAGE) day 0-3 compared to day 4-28 and day 0-7 compared to day 8-28 prior to consultation (for Substudy A) | The mean amplitude of glucose excursion assessed by CGM/FGM | 01.01.2013 - 31.07.2018; outcome assessed at study end |
適格基準
対象年齢
小児, 成人, 高齢者
試験の最低年齢
16 Years
対象性別
全て
- Diabetes mellitus
- CGM and/or FGM available for at least 50% of the time in last 4 weeks before consultation
- Written informed general consent for the retrospective analysis of data
- Pregnancy
Insel Gruppe AG, University Hospital Bern連絡先情報がありません。
1 1カ国の場所
Canton of Bern
Inselspital, Bern University Hospital, University of Bern, Bern, Canton of Bern, 3010, Switzerland