Coursework "Conceptual Design of a Telemedicine System"

Introduction

Purpose

The telemedicine system would facilitate communication between a diabetes patient and his GP. The system will enable the physician to suggest a probable cure or at least provide immediate relief to the patient even when they are physically apart. It aims to serve rural people, who do not have access to facilities instantly. Following are the requisite features of the telemedicine system:

  1. To define the requirements for the new telemedicine system (both monitoring and communication);
  2. To explore possible system configurations using various design methods (TRIZ, systems models and risk analysis);
  3. To outline the embodiment for the preferred system concept.

Business Context

National Health Service (NHS) trust is a business organization sponsoring the development of telemedicine system. Its objective is to develop a sturdy user-friendly telemedicine system to provide effective management of diabetes in lieu of a clinic visit.

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Scope

The system attempts to open channels for proper communication to be established between the patient and the GP. The system is useful for patients suffering from diabetes, nurses, physicians, health centres.

User Characteristics

Diabetes is caused when the body loses it ability to use carbohydrates for energy generation. This in turn gives rise to increased blood sugar level. Insulin is a hormone produced by beta cells found inside the pancreas. Insulin transports glucose from the bloodstream to various organs of the body. Glucose is a form of sugar, which supplies energy to the body. Insulin is responsible for controlling blood sugar level. In case of insulin resistance, the muscles, liver, and fat cells stop using insulin effectively despite the fact that adequate amount of insulin is produced in the body. As a result, the pancreas reduces insulin production in due course of time.

Amount of insulin that needs to be supplied to a diabetic person: 1ml-5ml. Insulin is dissolved in liquids at varying strengths and is then used. Commonly used insulin saturations include: U-100 and U-40. There are certain ingredients added in insulin to maintain freshness and improve workability. Intermediate and long acting insulin are made to act longer with the help of such additives.

Table 2: Types of Insulin
  RAPID ACTING (lispo) SHORT-ACTING (regular) INTERMEDIATE ACTING (NPH & lente) LONG ACTING (Ultralente)
ONSET Within 15 min. Within 30 min. After 2-6 hours After 6-14 hours
PEAK TIME 30-90 min. later 2-4 hours later 4-14 hours later No peak time or small: (10-16 hours)
DURATION 5 hours later 4-8 hours later 14-20 hours later 20-24 hours later

Ways to monitor blood glucose levels:

  • HbA1c (Blood Glucose Testing);
  • Blood glucose meter.

Various ways to supply the body with Insulin include:

  • Insulin pills;
  • Insulin shots;
  • Insulin pumps;
  • Insulin injections (Syringe);
  • Injection pen;
  • Inhaled insulin.
Table 1: Types & Characteristics of Diabetes
TYPE AGE-GROUP CAUSE EFFECT SYMPTOMS PRECAUTIONS & TREATMENT
Type-1 It is commonly found in children below the age of 20. Exact cause is not known. Probable causes include genetics, viruses and autoimmune problems. Insufficient or negligible amount of insulin produced in the body.
  1. Fatigue;
  2. Blurred vision;
  3. Unexplained weight loss;
  4. Hunger;
  5. Uneasiness;
  6. Increased thirst and urination;
  7. Weakness;
  8. Sweating;
  9. Nervousness;
  10. Rapid palpitations;
  11. Stomach pain.
  1. Healthy & balanced diet;
  2. Exercises;
  3. Daily insulin supply to the body in the form of injections, pills etc.
Type-2 Commonly found in adults.
  1. Hindered response towards insulin (insulin resistance);
  2. Sugar (glucose) doesn’t enter cells;
  3. Obesity;
  4. Low physical activity;
  5. Poor diet.
  1. High blood sugar level;
  2. Hyperglycemia.
  1. Blurred vision;
  2. Fatigue;
  3. Hunger;
  4. Increased thirst & urination;
  5. Erectile dysfunction;
  6. Pain & reduced sensation in the limbs;
  7. Slow healing.
  1. Healthy & balanced diet;
  2. Exercises;
  3. Weight control;
  4. Accurate & regular monitoring of blood sugar level;
  5. Proper medication.
Gestational diabetes Pregnant women
  1. High blood pressure;
  2. Excess amniotic fluid;
  3. Pre-pregnancy overweight conditions.
  1. Pregnancy hormones interfering with the activities involving insulin;
  2. High risk of causing type-2 diabetes;
  3. Can cause cardiovascular diseases later.
  1. Blurred vision;
  2. Fatigue;
  3. Increased thirst and urination;
  4. Weight loss but increased appetite;
  5. Increased chances of infection.
  1. Healthy, timely, and balanced diet;
  2. Accurate monitoring of the health and size of the foetus through ultrasound and non-stress test;
  3. Extra iron and calcium intake;
  4. Insulin therapy.

 In order to check for and diagnose diabetes, it is necessary to carry out urine test which would test glucose and ketone levels from the breakdown of fat.

There are two kinds of blood tests used to diagnose diabetes, these are:

  • Fasting blood glucose levels:

If blood glucose level is found to bear a value higher than 126 mg/dL twice, then the person is diagnosed with diabetes. However, if it lies between 100-125 mg/dL (millilitres per decilitre), it is said to be pre-diabetes or impaired fasting glucose level.

Both these conditions suggest the probability of type-2 diabetes.

  • Haemoglobin A1c test:

Besides helping patients to monitor and control their blood glucose levels, this test also enables diagnosis of diabetes and identifying pre-diabetes. The test indicates the condition according to blood glucose level detected. Levels indicate:

  • Normal- 5.7%;
  • Pre-Diabetes- 5.7% to 6.4%;
  • Diabetes- 6.5% or higher.

Higher blood glucose levels increases the susceptibility of the body towards other problems such as:

  • Blurred vision;
  • Cardiovascular diseases;
  • Kidney disease;
  • Stroke;
  • Nerve damage.
  • Oral glucose tolerance test (OGTT):

The test takes around 3 hours in which first a sample of blood is taken and tested. The person then is given a sample of glucose of around 75mg to drink followed by another round of blood glucose level testing after 30-60 min.

The results and their interpretation are as follows:

  • 60-100 mg/dL after fasting;
  • 200 mg/dL after 1 hour of fasting; Normalcy conditions
  • 140 mg/dL after 2 hours of fasting;
  • 140 mg/dL-200 mg/dL after 2 hours of fasting; Pre-diabetes
  • Higher than 200 mg/dL after 2 hours of fasting; Diabetes

The test requires insertion of a needle to take blood, which can be troublesome for some patients. Other risks associated with it include:

  • Excessive bleeding;
  • Hematoma;
  • Infection;
  • Nausea, blackouts.

Non-fasting (random) blood glucose level

It is another testing system to monitor blood glucose level using a portable device called glucometer. It comprises of test strips and small needles, known as lancets. The strip determines blood glucose level with the help of a chemical substance and uses digital medium to display results.

Normal blood glucose level lies within the range:

  • 70-130 mg/dL before taking meals;
  • Less than 180mg/dL post-meals.

Blood glucose levels lower than the above mentioned values indicate hypoglycaemia. Hyperglycaemia, however, is caused when the values lie at higher ranges than those mentioned.

Risk includes pain sensation due to the needle-prick. Some other factors that increase the risk of developing type-2 diabetes include race or ethnicity, genetics, and age.

Regulations and Standarts

There are several regulatory standards framed to ensure that patients are not deprived of their essential rights. Antitrust, state licensing, and other such state laws covering liability and malpractices do not create a congenial atmosphere for telehealth in the present scenario.

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Existing laws are still in development phase and need to be established in a manner that would encourage the telemedicine system. Medical practitioners are supposed to deliver their services within their own states and as of now provision of services across borders is yet to be legalized. John Oxedine, the State Commissioner of Fire Safety and Insurance of Georgia, developed the Georgia Partership for TeleHealth in collaboration with the state medical board and the state insurance industry. This incident laid foundation for legalization of telemedical system.

Functional Profties

  • The telemedicine system offers improved disease management and enhanced quality of care;
  • Eliminates need for manual data recording and transfer of measured values;
  • Physicians can access data anytime via the Internet and can give appropriate suggestions. They can also correct any deficiency or lacunae in the current treatment pattern.

Physical Proferties

  1. Bluetooth enabled meter;
  2. Wireless transmission services in the mobile phone, laptops etc.
  3. Real time transmissions;
  4. Automatic transference of patient’s test results in their online log book. The details can then be accessed by their caregivers;
  5. Internet connection;
  6. Disk storage space.

Interface Requirements

  • Administrator section: This section will be managed by patients, who will have administrative rights and can grant accessibility rights to their caregivers. Its key function is to provide security to the system.
  • Data section: Patient’s data should be accessible to caregivers and should be secure as well.
  • Alerts: The GP can set alerts about the schedule of exercises and prescribed medicines with a help of various user-friendly features such as IMs (instant messaging), e-mails, text messages etc. Any change required in the schedule can also be notified to the patient instantly.
  • Add on(s): Availability of add on(s) like e-books on diabetes, health guides, exercises and training programs, blogs. Besides this, it can also be used by caregivers for advertising and hosting diabetes related information to attract potential customers.
  • Online store: A kind of medical store where every medicine can be made available in the required amounts is another desirable feature. In case a certain medicine is not available, the physician can provide guidance to the patient on an appropriate alternative.

Essential features of the interface are shown below.

Environmental Conditions

Any telemedicine revolves around the use of electronic devices of testing, storage, and transmission of patient’s data. It thus poses a threat of e-waste, exposure to excess radioactive radiations, etc. However, at the same time, it can also be considered an environmentally friendly and cost-effective method since it helps save a lot of paper, which would have otherwise gone wasted recording and maintaining data and other details.

Maintenance

It is one of the most important factors to be considered. Physical conditions and cleanliness of gadgets and devices used here must be properly taken care of. At the same time, software used for telehealth services needs to be updated periodically so that no loss of data takes place.

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Disposal

Older data forms which are no longer useful must be erased from the system to avert confusion. Hardware components must be reused after use.

Schedule

Step Task Duration
1 Purchasing the Bluetooth device and installing the necessary software. 2 days
2 Configure the software for 12 lead transmission. 30 min.
3 Prepare the hardware, physical location and total number of connections required. 2 days
4 Set up the internet service protocol. 1 day
5 Set up the dial-up internet account for a Bluetooth modem. 1 day
6 Establish dedicated analogue phone line for fax. 1 day
7 Set up & test the telemedicine system. 2 days
8 Install & configure the application. 1 hour/ machine
9 Test & verify the system. 2 days
10 VALIDATION  

Manufacturability

Components of telemedicine are either electronic, mechanical, or a combination of both. These have to be manufactured taking into consideration their specific requirements and the functions which they have to perform.

Documentation

Patient’s logbook is used to register details about the patient. These details include test results, treatments being currently undertaken, and exercises. It would also contain a record of treatment method carried out previously and the corresponding results. This information will then facilitate the patient to mark his progress and the caregiver to suggest better medication. The table below shows an example of a documentation file.