Experiment Protocol Biomedical Engineer in United Kingdom Manchester –Free Word Template Download with AI

This Experiment Protocol outlines the procedures for evaluating a novel biocompatible sensor designed for continuous glucose monitoring (CGM). The research is conducted by a team of Biomedical Engineers at the University of Manchester, United Kingdom. The primary objective is to assess the sensor's accuracy, reliability, and biocompatibility in vitro and in vivo. This protocol adheres to the ethical guidelines and regulatory standards set by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the National Health Service (NHS).

• To evaluate the accuracy of the novel CGM sensor compared to standard blood glucose meters.
• To assess the sensor's reliability over a 14-day period.
• To determine the biocompatibility of the sensor materials through in vitro and in vivo testing.
• To ensure compliance with UK regulatory standards for medical devices.

3.1 Study Design

The study will be conducted in two phases: in vitro testing and in vivo testing. The in vitro phase will involve testing the sensor in controlled laboratory conditions, while the in vivo phase will involve testing the sensor on human subjects under clinical supervision.

3.2 In Vitro Testing

In vitro testing will be performed using simulated body fluids with varying glucose concentrations. The sensor's response will be recorded and compared to known glucose levels. This phase aims to establish the sensor's baseline accuracy and sensitivity.

3.3 In Vivo Testing

In vivo testing will involve a cohort of 50 participants with type 1 diabetes. Participants will be recruited from the Manchester Royal Infirmary. Each participant will wear the novel CGM sensor for 14 days. Blood glucose levels will be measured using standard blood glucose meters at regular intervals for comparison.

Participants will be recruited through the Manchester Royal Infirmary's diabetes clinic. Inclusion criteria include:

• Diagnosis of type 1 diabetes.
• Age between 18 and 65 years.
• Ability to provide informed consent.

Exclusion criteria include:

• Pregnancy.
• History of severe allergic reactions to medical devices.
• Current participation in another clinical trial.

Data will be collected using the following methods:

• Continuous glucose readings from the novel CGM sensor.
• Blood glucose measurements using standard blood glucose meters.
• Participant-reported outcomes, including comfort and ease of use.

All data will be stored securely in compliance with the UK's General Data Protection Regulation (GDPR).

This study has been approved by the University of Manchester's Research Ethics Committee. All participants will provide written informed consent before enrollment. The study will adhere to the principles of the Declaration of Helsinki and the UK's MHRA guidelines for clinical trials.

Potential risks include skin irritation at the sensor site and minor discomfort during sensor application. Participants will be monitored regularly, and any adverse events will be reported immediately. A risk management plan has been developed to address these potential issues.

Data will be analyzed using statistical software. The accuracy of the novel CGM sensor will be assessed using the Mean Absolute Relative Difference (MARD) metric. Reliability will be evaluated by comparing sensor readings over the 14-day period. Biocompatibility will be assessed through histological analysis of tissue samples.

This Experiment Protocol provides a comprehensive framework for evaluating the novel CGM sensor. By adhering to rigorous scientific and ethical standards, the Biomedical Engineers at the University of Manchester aim to contribute to the advancement of diabetes management technologies in the United Kingdom and beyond.