The Seafarers' Continuous Glucose Monitoring Systems Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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 the competing priorities of individual rights against public safety.
Modern treatment, with advances in insulin therapy and glucose monitoring, combined with rigorous clinical assessment and review, has allowed stereotypical attitudes to be challenged and advocated individual assessment with respect to safety criteria. Along with the UK Driving and Vehicle Licensing Agency (DVLA) and Civil Aviation Authority (CAA), the Maritime and Coastguard Agency (MCA) have accepted that insulin-treated diabetes should not be an absolute contra-indication to partaking in these occupational activities4. However, as the Disability Discrimination Act (1995) recognises that there may be specific employment-related hazards, fitness to work should be assessed on an individual basis. Therefore, each of these transport agencies has established regulatory standards for their respective domains, with the priority of minimising hypoglycaemic incapacitation risks. The CAA, for example, has worked alongside other European countries to use the ARA.MED.330 protocol and require medically certified pilots to check their blood glucose levels regularly before and during flights. In 2010, the UK CAA's expert committee reviewed the knowledge and policies concerning flying and it was decided that Continuous Glucose Monitoring (CGM) systems were not accurate enough and instead used finger prick-blood glucose monitoring (SMBG) as the gold standard. Since then, the protocol has been successfully implemented and there are current works in progress that demonstrate sufficient accuracy in modern CGMs as a viable alternative to SMBG.
Similarly, the guidelines devised by the MCA, Approved Doctor's Manual (ADM), place a great emphasis on the type and treatment of diabetes, with the primary concern being risks of cognitive impairment or incapacitation5. Emphasis is placed on the need for able glycaemic control and "full awareness of impending hypos, with no reported or observed significant hypoglycaemic episodes in the last year". The guidance stipulates that certification may be restricted on individuals pending their medication side effects, compliance, and vascular risk factor control. Previous regulations prevented seafaring individuals such as insulin-treated seafarers from partaking in lone watchkeeping/lone-working roles and restricted them to near-coastal duties (150-200 nautical miles) (Appendix 1). Current regulations allows for exemptions for certain vessels, provided that the seafarer's diabetes control remains stable and is subject to blood glucose monitoring. Regardless, an approved medical assessor is needed to conduct these specific medical assessments in line with the statutory standards in MSN 1886 and guidance in the ADM.
All seafarers who are insulin-dependent and licenced to undertake seafaring in the UK will be invited to participate in this study.
详细描述
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 undertake commercial work at sea and will be taking corrective actions according to their glucose readings. The CE marked Dexcom G7® will be provided to the participants in the study for 1 year. A questionnaire is designed to streamline the process of the glucose management while at sea. Additionally, a progressive web app (Fishers Watch) will be provided and accessible by participants via their own smartphone devices to enable better recording of adverse/diabetes-related events and activities during the study and can also help indicate their on- and off-duty periods to facilitate data analysis.
Participants will be encouraged to use their CGM glucose measurement data from their own devices, to assist with their diabetes management. The involvement of the participants in the study will be 12 months. The participants will be reminded during the study that it is crucial to log their CGM glucose measurements alongside their activities and any hypoglycaemic/hyperglycaemic episodes within this timeframe.
Screening/run-in period Seafarers will be recruited via the MCA ML5 or ENG1 medical certification processes for medical certification (see Appendix 2). All insulin treated seafarers who presenting for an ML5 or ENG1 certificate who are assessed as fit to work at sea will be asked for and will be provided with information and a consent form for the Scheme6 (Appendix 3). All signed consent forms confirming to be approached by the investigators at the University of Surrey, will be forwarded to the investigators at the University of Surrey. We, the investigators at Surrey, will then have the email contact for the seafarer and we can then approach the interested seafarers directly (Appendix 1 Supplementary Material 2).
Screening visit (Virtual visit 1)
All seafarer will be invited for a virtual/online/phone screening visit. The virtual meetings will be held on TEAMs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Outside of the stated age range.
- •Not able to use using a CGM glucose monitoring system for monitoring the glucose levels.
结局指标
主要结局
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.
时间窗: 12 months
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.
次要结局
- Feasibility and safety assessment of using CGM systems during seafaring activities(12 months)
- 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)(12 months)
- Questionnaire data an overview of participants' preferences(12 months)
