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治験 NCT07251257 ((SeaGM))（対象：インスリン依存型糖尿病）は募集中です。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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The Seafarers' Continuous Glucose Monitoring Systems Study ((SeaGM)) 50
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治験番号 NCT07251257 ((SeaGM)) は 観察研究 臨床試験 で、インスリン依存型糖尿病 に関するものです。現在は 募集中 で、2025年11月20日 から開始しています。50 名の参加者 の募集が計画されています。この試験は University of Surrey によって主導され、2027年4月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年1月6日 です。
概要
People with diabetes sometimes consider that they are subjected to unfair discrimination in the occupational or work environment. These include safety-critical activities, such as operating machinery and driving 1-3. Some occupations preclude the use of medications that lower blood glucose, particularly insulin. Safety regulators, occupational health physicians and national organisations frequently have to balance th...もっと見る
詳細説明
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYSIS This will be an observational and feasibility study on the use of the insulin-treated fisher seafarers' with or without own real-time CGM systems, such as Dexcom G6®, Dexcom G7®, Guardian 4 or Abbott Freestyle Libre. The participating seafaers with insulin-treated diabetes who are currently monitoring their glucose levels using a CGM and certified to under...もっと見る
公式タイトル
The Seafarers' Continuous Glucose Monitoring Systems Study
疾患名
インスリン依存型糖尿病刊行物
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
- (SeaGM)
- FHMS 23-24 062 EGA/ERM ID 2469
- #1716 (その他の助成金/資金番号) (Seafarers' Charity and Fishmongers Company in UK)
NCT番号
開始日
2025-11-20
最終更新日
2026-01-06
終了予定日
2027-04-01
目標参加者数
50
試験の種類
観察研究
状況
募集中
キーワード
insulin dependent diabetes
Continuous glucose monitoring
Seafarers
Fishers
Continuous glucose monitoring
Seafarers
Fishers
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
Seafarers wearing CGM device Fifty seafarers will be recruited to participate in a one-year study utilizing the Dexcom G7 Continuous Glucose Monitoring (CGM) system.
Participants will also be enrolled in the web-based Fishers Watch application, which will deliver daily reminders via text message prompting them to note on their activities both at sea and on land. | 該当なし |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
To evaluate the glucose monitoring of CGM systems in the context of their usual occupational activities and establish its feasibility as a routine glucose monitoring device while at sea. | Evaluation of the glucose monitoring of CGM systems in the context of the seafarers' usual occupational activities and establish its feasibility as a routine glucose monitoring device while at sea. Glucose measurements will be based on a traffic light system, with \<5 mmol/L coded as red, 5-20 mmol/L as green, and \>20 mmol/L coded as red as per our maritime protocol. | 12 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Glucose variability while working or on rest period at sea | Glucose variability while working or on rest period at sea | 12 months |
Time in and out of range while seafaring (targets used as other clinical trials) | Time in and out of range while seafaring (targets used as other clinical trials) | 12 months |
Feasibility and safety assessment of using CGM systems during seafaring activities | Glucose variability while at sea in comparison to on land | 12 months |
Questionnaire data an overview of participants' preferences | Questionnaire data will provide an overview of participants' preferences towards glucose monitoring devices and their trust in the systems used to manage their glucose levels. | 12 months |
参加アシスタント
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
•
- Any ethnicity
- Seafarers requiring insulin replacement therapy,
- Holding a valid ML5 or ENG1 certificate
- Able and willing to wear a Continuous Glucose Monitoring system (GCMS) for 12 months
- Able and willing to document out of range glucose values and activities in Fishers Watch App a while at sea
- Outside of the stated age range.
- Not able to use using a CGM glucose monitoring system for monitoring the glucose levels.
University of SurreyThe UK Maritime and Coastguard Agency試験中央連絡先
連絡先: Fariba Shojaee-Moradie, Ph.D., +441483464049, [email protected]
連絡先: David L. Russell-Jones, M.D. FRCP., +441483464049, [email protected]
1 1カ国の場所
Surrey
University of Surrey FHMS Nutritional Sciences, Guildford, Surrey, GU2 7WG, United Kingdom
Fariba Shojaee-Moardie, PhD, 連絡先, +44 1483 688644, [email protected]
David AM Russell-Jones, MD PhD, 連絡先, +44 1483 464049, [email protected]
David Russell-Jones, MBBS PhD, 主任研究者
Fariba Shojaee-Moardie, PhD, 副研究者
募集中