Wed, Nov 22, 2017

Frequently Asked Questions

General Information

Q: What is the MobiGuide project?

A: The MobiGuide (MG) project is a European ICT project funded under the EC’s Seventh Framework Programme. The project involves 13 partner organizations from 5 countries. The members of the MG project are developing a ubiquitous guidance system that provides secure personalized clinical-guideline-based decision support to physicians through web interfaces and to patients via Smartphone interfaces. Guidance is specific to patient data stored in a Personal Health Record that semantically integrates data acquired from hospital medical records and from wearable sensors.

Q: What is the MobiGuide system?

A:  MG is a patient guidance system that provides guidance ‘everywhere, anytime’. 'Everywhere' means it will give you guidance wherever you are and ‘anytime’ means guidance is not restricted to office hours but provided when you need it. Its ubiquity is achieved by distributing decision support between a backend Decision Support System (DSS) server that has access to the complete patient health record and a mobile DSS (mDSS) that operates on a patient's local system. The patient's local system consists of a Smartphone and a set of wearable monitoring devices that can operate independently, while receiving its knowledge from the central server and its data from the monitoring devices. The knowledge for the central DSS is acquired from evidence-based clinical guidelines that are represented as computer-interpretable guidelines (CIG). Personalization of the CIGs is achieved by considering patient preferences (e.g., preferred meal times allow delivery of reminders before or after meals) and personal context (e.g., holiday context at which exercise schedule is more relaxed). Retrospective data analysis will be used to assess compliance and to indicate care pathways shown to be beneficial for certain patient context.

Q. What is the MobiGuide pilot?

A: The pilot system is developed for the domains of (a) gestational diabetes with/without hypertension and (2) atrial fibrillation. During the MobiGuide project groups of patients who meet the pilot's eligibility criteria (i.e., match eligibility criteria for the clinical guidelines, have been evaluated by  the  doctors from the MobiGuide team, and have signed the consent form)  at two trial sites will be offered the chance to participate in the pilot so that the MobiGuide system can be evaluated.

Q: If I were a patient participating in the pilot, how could the MG system help me adhere to my treatment recommendations?

A: MobiGuide is designed to help you adhere to your treatment recommendation by providing multilevel support:

  • Personalized reminders – The system operationalizes care actions, such as measurements (e.g., blood glucose measurements, blood pressure), medications, diet and exercise by offering personalizable schedule tables. Once you have defined which activities you would like to receive reminders about and at which times (e.g., to measure your fasting blood glucose level 15 minutes before your preferred breakfast time during weekdays; to exercise; or to take your medication), the system will remind you to perform these activities
  • Feedback – the system will provide you with feedback about your health state and your compliance with the recommended treatment.
  • Alerts – the system will alert you in any case there is need. When needed, the system will ask you to contact your care provider. Feedback will also be provided to your care provider.
  • Data storage – the system will collect the measurement results and will provide them to your care provider.
  • Supporting your changing personal context – the system will be able to provide predefined recommendations that are appropriate for your different personal context (e.g., holiday schedule, spouse unavailable to assist).
  • The system is sensitive to the quality of data (QoD) and takes measures to increase safety when the QoD is low (e.g., asks for data re-entry).

Safety, security, and privacy

Q: Does the system replace physicians?

A:  The system does not replace physicians and the patients are followed according to the regular procedures used today by their physicians while providing feedback, reminders, and alerts that increase compliance and safety. The commercial medical devices used as sensors meet the relevant safety regulations and have been certified safe for use.

Q: How do I know that the system recommendations are based on clinical evidence?

A: The MobiGuide project is working with clinical experts and with the most up-to-date clinical guidelines to ensure that the system recommendations are evidence based. The system is evaluated by EU committee to make sure that all the recommendations are evidence based. The guidelines that the MobiGuide project is using are:

  • For the AF domain –Guidelines for the management of atrial fibrillation. The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC).  
    http://eurheartj.oxfordjournals.org/content/31/19/2369.full
  • For the GDM domain, MG uses an adaptation of the International commonly implemented clinical guidelines:  SED, ADA, NICE, AACE, and ACOG.

Q: How can I make sure that my information is protected in terms of privacy and security?

A:  The system follows the "privacy by design" principles by which the system design enforces privacy and security using mechanisms for:

  • authentication: verifying that "you are who you say you are";
  • authorization verifying that "you are permitted to do what you are trying to do";
  • awareness: functionality to enable the users to be informed of the usage made with their data.

The system's security and privacy design considers relevant European/national data protection regulations to make sure that only needed health information will be provided, only to authorized parties and for authorized purposes which are to the benefit of patients.


System Usage

Q: Can I start using the MG system?

A: The pilot system is currently under development and will first be evaluated by specific groups of patients during the MobiGuide pilot in 2015. Following the end of this evaluation, the MobiGuide team will produce a roadmap for future implementation of Patient Guidance Services for the coming decade in preparation for introduction of the service into routine clinical practice.

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Q: What will happen if the system detects that something is wrong?

A: in case the system detects that something is wrong it will alert the patient and the medical staff. For each clinical domain the system will react based on the clinical guideline and upon the specific actions defined by the physician.

Q: How can I see the data that the system collects?

A:  The collected data is sent to your doctor. You can see some of your own data in the MG system. In case you want to see more data, you can request it from your doctor. The doctor has the final responsibility to check your charts and to provide you with medical reports.

Q: How do I transfer my data to the doctor?

A:  The doctor has an interface to view the data so you do not need to transfer data yourself.

Q: Who will explain to me how to use the system? If I don't know to work with gadgets, will it be a problem to understand how to work with the system?

A:  Every patient enrolled in the MobiGuide project pilot will receive training before starting to use the system. In case of any question or problem, the patient will be able to contact his nurse or the technical team of the project for help while enrolled to the MobiGuide pilot system.

Q: When using the MG system, can I use my own smartphone and monitoring devices (e.g., glucometer)?

A: The MG system uses an architecture that allows us to plug-in different devices. During the pilot, we will provide all of the devices, including a Smartphone. In case you are currently using alternative devices (e.g., your own glucometer) please consult with your physician about using your own device.

Q: Do I need to enter a lot of information in order to use the system?

A: No, the system reduces the amount of data that is required to be entered by the patient, since in most of the cases the system receives the data directly from the device and from hospital medical records. In some cases, where the quality of data is in question, the patient will be asked to confirm the data in the system.

Q: how will I be involved in the decision process together with my doctor?

A: Some of the medical decisions have to follow the medical guidelines while others require a shared decision between the patient and the doctor. In this latter case, during the enrollment and during the following months when the system will be in use, you will be involved in the decision making process by defining your preferences and your personal information. Your doctor will work together with you to understand which treatments and their expected consequent health states, are most suitable to your personal preferences and bring the best utility to you.

Q: How am I expected to interact with the system?

A: you will be expected to interact with the system by using MobiGuide's smartphone application.

Q: If I will encounter a new situation that I didn't discuss with my doctor, what is expected of me?

A: In this case you should continue to follow the given treatment recommendations and set a new appointment with your physician to try and define more suitable recommendations to the new situation.

Q: When should I contact my doctor?

A:  At the beginning of the study the doctor will set some scheduled follow up visits according to the protocol and the medical needs. In the case something unexpected happens you should keep the standard routine with your physician and use the usual means to contact him (e.g., call the clinic). In case the system detects anything wrong it will advise you to contact your physician. In the case of an emergency you do not have to wait for a feedback from your doctor but instead go to the closest emergency department.

Q: How does the system take into account my preferences?

A: During the enrollment, the physician adds your preferences to the system and defines treatment recommendation based on your clinical and personal context and on your preferences.

Q: How will I know whether I'm using the system correctly?

A: The system will indicate to you in case you are providing any wrong data or in case it detects that you are not using it correctly. In any case, the MobiGuide staff will be available to provide additional support according to the service-level agreement indicated in the patient's consent form.

Q: How will I get updated on how well I'm complying with recommendations and regarding my health status?

A: The system will send you indications as to whether you are complying or not with your treatment recommendations. In order to see your health status you will be able to see some of the data through the smartphone; to see your full PHR you must ask your physician to send you your records.

Q: How will my doctor receive information about my compliance?

A: your physician can access your data file to see how well you comply and what your health state is. In case your degree of compliance can increase your risks, your doctor will be informed by the system.

Q: Will I have to install updates? If so, when?

A: During enrollment the MG administrative team will provide you with a Smartphone on which the MobiGuide application has been installed and will activate auto update option of the application. You will be able to set your personal context to your current state and to change your preferences whenever you wish.

Q: How can I make sure that the system data is up-to-date?

A: The system's knowledge is updated through the auto update option of the application (see above). In addition, the system's sensors that are connected to your smartphone collect up-to-date data all the time. The backend system is updated continuously whenever there is Internet connectivity. In case there is no connection, the data is saved until connection is restored. You don’t have to do anything about it. The system reacts on collected data, when you are too long not connected, the system notifies both you and the caregiver.

Q: How can I provide feedback about the system? Do I send it to my doctor, nurse, or directly to the developers?

A:  You will be able to enter the MG project site and provide feedback directly to the developers. You can also ask your nurse or doctor to send your feedback as well. In the case you are unable to reach an internet connection you may call your doctor/nurse.

Q: Can you describe the daily routine with the MG system?

A: The following story explains by giving an example of enrollment and routine use of the MG system. The story is about a fictional patient called Montse who develops diabetes during pregnancy (this condition is known as gestational diabetes, or GDM for short). The GDM version of the MobiGuide system helps Montse and her medical team to monitor and manage her condition.

  1. Enrollment to MobiGuide:

Montse is a pregnant woman of 34 suffering from gestational diabetes. Her pregnancy was monitored in primary care until they diagnosed gestational diabetes and she was referred for monitoring and treatment to the hospital. In the hospital, she receives education on her disease, different types of therapies, blood glucose control and nutritional aspects.

In the hospital, all kind of data about Montse is collected and stored in the EMR to perform (extended) diagnosis and determine the following steps in her treatment. For example, the Oral Glucose Tolerance Test (OGTT) performed in primary care is also stored in the hospital electronic medical record (EMR).

Jim is an endocrinologist at the Spanish hospital. Jim and Montse meet in the hospital for a regular visit. Jim discusses with Montse the progression of her gestational diabetes. He indicates that she is eligible for using the MobiGuide patient guidance system. He explains to her the advantages and disadvantages and Montse decides she is willing to use the system. After explanation, Jim and Montse sign the informed consent forms, and continue to enroll Montse in the Mobiguide System.

Jim logs-in to the care provider interface and starts the enrollment process of Montse. This process consists of four main steps: (i) initialization of PHR record and coupling to EMR, (ii) assignment to computerized clinical guideline and personalization, (iii) activation of the patient mobile system and (iv) starting of the patient guidance.

  1. Assignment to clinical guideline and personalization:

Jim continues to the second step of the enrollment process. Based on the visible OGTT results, Jim verifies the GDM diagnosis of Montse. He assigns her to the GDM computerized clinical guideline and further personalizes it towards Montse’s personal situation by augmenting her PHR record, some specific elements that are specified below. The system retrieves knowledge for further personalization.

Jim and Montse together explore all her personal context (e.g. asks her for regular situations she is in. They select two personal contexts: regular & on-holiday, and match them to the routine and semi-routine diet and schedule context defined during computerized clinical guideline customization, and confirm the pre-defined effect on the medical treatment. These mappings are stored in Montse’s personal health record (PHR) of MobiGuide.

They define Montse’s preferences regarding her number and timing of daily meal intakes, and indicate which meals should be associated with blood glucose (BG) measurements, for which of those should reminders be sent. They leave the default valid (of 30 minutes) that indicates how many minutes before the measurement  the reminder should be sent. This duration can be set either on the care giver UI or on the patient's UI. They specify that she normally takes three meal intakes: breakfast at 8:00, lunch at 12:00 and diner at 19:00, but during holiday, she likes to shift everything by 1 hour.  These preferences are stored in Montse’s PHR.

Jim continues to the third step of the enrollment process. Jim selects a pre-packaged set of Smartphone and appropriate monitoring devices (for GDM this is a glucometer and physical exercise detection monitor) from his cabinet and he first explains to Montse how to use it using the application's demonstration mode.

Jim provides Montse with the MobiGuide phone and devices, her username and activation code.

Together they activate the MobiGuide system using the smartphone application. Montse starts the app, which asks her for her username and activation code. This information is checked by the system, and Montse is asked to register her personal pin-code.

Montse is asked to select her current context; she presses a button on the application to indicate that she is currently in her ‘Regular’ context.

The MobiGuide application indicates: “Congratulations, you are enrolled in the MobiGuide system. From now on, you will receive recommendations”.

  1. Daily routine:

Montse is living her daily life. According to her measurement plan, she is measuring BG levels regularly (4 times, every day in personalized hours). Today she is having lunch in her work restaurant. She knows that she has to measure BG after eating her lunch hence she uses the glucometer to perform the measurement and takes the MG smartphone from her purse in order to record the result.

Montse logs-in to the MG app, navigates to the BG measurement screen measures and enters her BG level. In the last 3 days, BG levels have been normal. The MG system detects this compliance pattern and acknowledges Montse’s good BG measurement compliancy with the following message: “Congratulations, you are following recommendations about blood glucose monitoring very well.”

The building is quite massive and she has flaky wireless internet coverage. However, when she goes online the blood glucose and compliancy data is also stored into the PHR. 

  1. Low compliance detection:

A week passed. During this week, Montse is working on an important report. As a result she sometimes forgets to monitor BG. Additionally, she indicated already once that she did not follow diet prescriptions. Today she is having lunch at the park and she takes out her smartphone to measure BG data and enter diet information.

Montse logs-in to the MG app, she navigates to the diet page and indicates she did not eat according to her diet prescriptions. She navigates to the BG measurement page and enters her BG, which is 115 and is normal. The MG system detects a non-compliancy pattern with two times in 3 days that Montse didn't comply with diet and didn't report several BG measurements during those 3 days. MG notifies the care provider on the situation.

In the hospital, during his inspection of his patients, Jim logs-in to the caregiver interface and opens Montse’s record and sees there is a recommendation asking for acknowledgement regarding the non-compliancy and suggesting that with a click of a button he can send Montse an educations reinforcement message. He reads the recommendation and decides to send the educational reinforcement message to Montse: “Remember that it is very important that you keep following diet recommendations and measuring blood glucose frequently”. 

  1. High BG levels falsely detected:

The next morning Montse receives a recommendation at her specified breakfast notification time to measure her BG. She logs-in to the MG app and enters a 193 mg/dL glucose level. The system recognizes that this value is pretty high (compared to her previous measurements) and this might indicate a possible error in the entered value. The system asks Montse to re-enter her BG measurement.

Montse directly sees her mistake; she was a bit sleepy this morning and she by accident entered a wrong value. She wanted to input 93 mg/dL. Luckily she gets the opportunity to correct. The system recognizes this more likely value, which is within normal range. The correct data is stored in the PHR.

  1. Good metabolic control:

Montse recovered from a small period of non-compliancy. During the past month, she was very consistent in sending BG measurements. Because BG levels were normal along the period, the clinical context of good metabolic control is true for Montse. The system detects this context and sends a recommendation to the Jim to indicate that it might be possible to decrease the frequency of monitoring BG levels.

Jim logs-in the caregiver interface and looks at the received recommendation. He acknowledges the proposed changes in treatment. The MobiGuide system sends new projections to her mobile phone with the new scheduling.

After the mobile decision-support system analyzing it, Montse receives a message to indicate that her treatment is changed and that she can measure blood glucose levels twice a week instead of every day: “Your blood glucose levels show an appropriate glycemic control; you can reduce the number of daily measurements to measure blood glucose twice a week” (3-4 times a day but only twice a week).


Atrial Fibrilation

Q: What is atrial fibrillation?

A: Atrial fibrillation is an alteration of the heart rhythm in which the heart area that normally controls the electrical activation (the "sinus node") is "overwhelmed" by the activity of other parts of the right atrium or left atrium (the atria are the upper chambers of the four chambers that make up the heart). As a result the electrical activity of the atria becomes completely chaotic and the heartbeat (pulse) becomes irregular.

AF

Q: What are the symptoms?

A: The main symptoms experienced by people suffering from atrial fibrillation are palpitations, or the feeling of an irregular, accelerated heartbeat. Other symptoms include shortness of breath( at rest or during exercise), dizziness, syncope (i.e., loss of consciousness for a few seconds with spontaneous recovery), fatigue, and tiredness. Angina pectoris (chest pains) can also occur.

Q: What are the consequences of atrial fibrillation?

A: Apart from a few exceptional cases, atrial fibrillation is an arrhythmia that does not pose a risk to life. However, its complications can be very serious. In fact, atrial fibrillation is a major cause of stroke.

Q: How frequent is atrial fibrillation?

A: Atrial fibrillation is the most common cardiac arrhythmia (about 0.5% in the general adult population). The risk of disease increases with age: in the over 65s, the percentage of people with AF rises to 5% or more. Rarely atrial fibrillation occurs in patients in whom the heart is structurally intact (that is, they have no other demonstrable heart disease). These cases represent approximately 10-15% of all atrial fibrillation patients and can be caused by genetic defects (mutations) and may present familial distribution (that is, this condition “runs in the family”). In most cases however the arrhythmia occurs in patients who have other cardiovascular diseases such as hypertension, coronary artery disease and diseases affecting the valves of the heart (valvular disease). For example, 30%-80% of patients who are operated on for mitral valve disease have atrial fibrillation. Atrial fibrillation also commonly occurs after all types of cardiac surgery. In these cases, if the diameter of the atria is normal, the arrhythmia almost always disappears after few days.

Q: Are there different types of atrial fibrillation?

A: After a first episode of atrial fibrillation is very important to distinguish whether the arrhythmia was spontaneous (normal heart) or induced by other causes. A careful analysis of symptoms can be of help. Of note, not all episodes of atrial fibrillation are felt/noticed by patients. This can make diagnosis difficult. In patients in whom there were at least two episodes of atrial fibrillation with spontaneous return to sinus rhythm within seven days, atrial fibrillation is called "paroxysmal" (sometimes referred to as “recurrent”). If the episodes last more than 7 days and/or a medical intervention is necessary to restore the normal heart rhythm, atrial fibrillation is classified as "persistent". In cases where medical interventions are ineffective and atrial fibrillation persists more than 7 days arrhythmia is defined as "permanent." Of note these categories are not mutually exclusive since a patient may experience transitions from one category to another. 

Q: What are the most important consequences of atrial fibrillation?

A: Atrial fibrillation is worrisome for its complications rather than for the arrhythmia itself. Indeed, importantly, since atrial fibrillation often occurs in association with other heart (cardiac) or extra-cardiac diseases (for example, valvular defects, heart chamber enlargement, coronary artery disease, diabetes, hypertension). Thus, the clinical evolution depends also on the so-called "co-morbidity morbidities" (i.e., the "other" heart diseases). Atrial fibrillation is a cause of cardiovascular complications (for example, it can aggravate heart failure), and it causes a reduction in tolerance to physical activity. However, the most severe complication is caused by stagnation of blood in the atrial chambers (due to the loss of coordinated contraction). This promotes the formation of blood clots (thrombi) on the walls of the atrium. If the blood clot detaches it is often dragged by the blood flow to the arteries of the brain (due to anatomical reasons) so they can become clogged causing a stroke. For this reason, patients with atrial fibrillation are commonly treated with anticoagulant drugs.

Q: What are the treatment strategies?

A: There are two main treatment strategies: cardioversion, which is the attempt restore the normal “sinus” rhythm (“rhythm control strategy”) or control of heart rate ("rate control strategy”). The rhythm control strategy, if effective, allows minimizing the symptoms and risks described above. It also enables discontinuation of the administration of anticoagulant drugs. The maintenance of sinus rhythm, however, is often difficult or impossible, especially when ultrasound shows an increase in the diameter of the atria. The possibilities of therapy are focused on the use of antiarrhythmic drugs (pills) or radiofrequency ablation.

Q: What is radiofrequency ablation?

A: Radiofrequency ablation (RFA) is an invasive procedure aimed and creating thin scars in the atria in order to interrupt the arrhythmia. The idea is that by creating these scars (using radio waves) the electrical conduction of the arrhythmias is made impossible. There are different ways of performing RFA but all of them require inserting a wire (catheter) in the right and left atria.  The catheters are usually inserted through the femoral vein and femoral artery (other approaches can be used). The doctor first records a map of the electrical activation of the atria to select the best zone to apply the RF energy. Than he/she deliver a series of electrical impulses and re-checks the electrical activation map to assess the effects of the RFA trreatment.  At the end of the procedure the doctor tries to induce atrial fibrillation to demonstrate that the arrhythmia is no longer inducible. In some instances the ablation is not complete and the arrhythmias can recur even if the initial result of RFA is satisfactory. 

Q: Which is the most effective therapy?

A: The most important concept to consider is that the efficacy of the therapy depends on the cardiac co-morbidities. For example therapy is more effective for atrial fibrillation occurring in the structurally normal heart than for one occurring in patients with valvular heart disease and with enlarged atria diameter. Therefore treating the cause of atrial fibrillation is at least as important as treating the arrhythmia.  Neither drugs nor ablation are completely effective and the possibility of recurrent atrial fibrillation is between 40% and 50%. Ablation technique has made remarkable advancements in the last few years. However for several patients rate control strategy is the only feasible option. In such instances the correct use of drugs to optimize the cardiac rate (at rest and during exercise) and the administration of anticoagulants is extremely important to improve the patient’s quality of life. 

Q: What is the purpose of the Mobiguide project?

A: MobiGuide is a European project which develops an innovative telemedicine system to support patietns wihth chrinic diseases including atrial fibrillation. The MobiGuide telemedicine system enables home monitoring of patients with atrial fibrillation, and also provides clinical indications and "guided/knowledge-based suggestions" to both patients and doctors. The knowledge in “knowledge-based” here refers to the latest scientific  evidence about the best medical treatment for atrial fibrillation; this knowledge is found in clinical guidelines. Guidelines are documents developed by panels of scientific experts; a guideline brings together all the best scientific evidence about the most effective treatments in different circumstances.
The concept of "guided suggestions" is very important and represents an innovative aspect of the system. MobiGuide is an intelligent system that continuously checks the medical guidelines and send recommendations based on the integration of the patient’s clinical data with the medical evidence which is  recorded in the guideline. The core of the MobiGuide system consists of "intelligent" software that can identify the recommendations from the medical guidelines which are adapted to the clinical condition of each patient and can present them to the cardiologist, who can choose whether to accept or modify the proposed solutions. Moreover, MobiGuide is able to take into account the preferences of the patient on every occasion in which the choices are not strictly necessary or completely pre-determined by the clinical situation.

Q: Which kind of information is provided to the patient?

A: MobiGuide can support the patient in the daily management of their therapy, for example by sending a reminders each time a pill should be taken. The system can record an electrocardiogram and send it to the doctor (the recording can be also done on the doctor’s request). The patient can use a smartphone to enter important information such as symptoms and blood pressure and provide the doctors with information useful for clinical management without the need for the patient to physically visit the hospital every time. Finally MobiGuide can support the patient to better follow their physical training rehabilitation protocol. 

Q: How MobiGuide can improve my medical condition?

A: MobiGuide collects clinical information available at the time the system is initiated and integrates it with clinical information gathered by a system of sensors and online clinical data collection. The sensors (ECG recorder, blood pressure meter) collect data that are integrated with clinical data on medication actually taken (MobiGuide's support system for the management of complex schemes of therapy). The data are processed by the "expert" system that is able to extrapolate the appropriate guideline(s) and personalized patient preferences. For example, the MobiGuide is able to suggest to the patient if there is the need of  taking specific therapy (“pill in the pocket”) in the event of a new episode of atrial fibrillation detected by the ECG sensor. Another very important function of the system is that of supporting the patient in correctly following the doctor’s prescription relating to use of anticoagulant drugs. 


Gestational Diabetes

Q: What is gestational diabetes?

A: Gestational diabetes is a type diabetes which is diagnosed during pregnancy. As in other forms of diabetes, it is characterised by inappropriately high blood sugar levels.

Q: How MobiGuide can improve my medical condition?

A: MobiGuide collects clinical information available at the time that the system is initiated and integrates it with clinical information gathered by a system of sensors and online clinical data collection.
The data are sent to the MobiGuide system where they are processed by the "expert" system that is able to extrapolate from the appropriate guideline(s) and personalized patient preferences.
For example, the MobiGuide system is able to suggest to the patient if there is the need to increase carbohydrates (glucose) in her diet. Another example is that the system can reccommend that the patient checks her blood pressure again if a blood pressure reading is too high. This may indicate that the patient made a mistake in typing in the blood pressure reading (a data entry error). It is important to distinguish between data entry errors and a genuine case of high blood pressure levels.

Q: Which kind of information is provided to the patient?

A: MobiGuide can support the patient in the daily management of their therapy, for example by sending reminders about the importance of diet and the need to exercise daily.
The patient can use a smartphone to enter important information such as daily readings of capillary glycemia, ketonuria, proteinuria and blood pressure. This provides the doctors with information useful for clinical management without the need for the patient to physically visit the hospital frequently.

Q: What are the main complications in the newborn?

A: Although the rate of complications is very low, babies born to mothers who had gestational diabetes may have:
- Low levels of blood sugar (hypoglycemia)
- Low levels of calcium and magnesium in the blood
- Neonatal jaundice
- Respiratory problems (breath problems)
Hypoglycemia is the most common complication, but even so the incidence is low. Hypoglycemia is checked for by measuring the newborn's blood glucose in the first 1-2 days of life.

Q: How is gestational diabetes diagnosed?

A: All pregnant women are screened to detect gestational diabetes.
Usually, the test is done between 24 and 28 gestational weeks. However, it may be done in the first trimester if risk factors are present.
The initial test is known as the "O'Sullivan Test" and measures blood sugar 1 hour after taking 50g of glucose. If the glucose value is abnormal, a further test known as the Oral Glucose Tolerance Test (OGTT) is needed. II If however the glucose value is normal, gestational diabetes can be excluded. With the OGTT test, sugar is measured in fasting conditions and then every hour for 3 hours after taking 100g of glucose. If two or more blood glucose values are raised, a diagnosis of gestational diabetes is confirmed.

Q: What is the purpose of the MobiGuide project?

A: MobiGuide is a European project which develops an innovative telemedicine system to support patients with chronic illnesses. Gestational Diabetes is one of the first chronic illnesses that MobiGuide is designed to support. Belwo we explain the MobiGuide system in relation to Gestational Diabetes. The MobiGuide telemedicine system enables home monitoring of patients with Gestational Diabetes, and also provides clinical indications and "guided/knowledge-based suggestions" to both patients and doctors. The knowledge in "knowledge-based" here refers to the latest scientific evidence about the best medical treatment for gestational diabetes; this knowledge is found in clinical guidelines. Guidelines are documents developed by panels of scientific experts; a guideline brings together all the best scientific evidence about the most effective treatments in different circumstances.
The concept of "guided suggestions" is very important and represents an innovative aspect of the system. MobiGuide is an intelligent system that continuously checks the medical guidelines and send recommendations based on the integration of the individual patient's clinical data with the medical evidence which is recorded in the guideline. The core of the MobiGuide system consists of "intelligent" software that can identify the recommendations from the medical guidelines which are adapted to the clinical condition of each patient and can present them to the endocrinologist, who can choose whether to accept or modify the proposed solutions. Moreover, MobiGuide is able to take into account the preferences of the patient on every occasion in which the choices are not strictly necessary or completely pre-determined by the clinical situation.

Q: What are urinary ketones?

A: When the body can not use glucose, cells use body fat to produce energy. This process results in production of ketone bodies which are excreted in the urine.
Taking in insufficient carbohydrates (glucose) or having long gaps between meals may result in ketonuria.
Ketonuria may carry risks for the unborn baby. For this reason, the recommendation is to follow correctly the diet which consists of 6 meals per day, and to take care not to omit or delay meals; also it is very important to measure ketone levels in the urine first thing every morning after waking up.

Q: What is the treatment for gestational diabetes?

A: The main goal is to manage blood sugar levels. This involves:
- Performing 4 capillary glucose checks per day (fasting and one hour after breakfast, lunch and dinner) with a glucose meter.
- Following a balanced personalised diet.
- Measuring urinary ketones every morning
- Following a programme of physical activity, if there is no contraindication
If following the diet and physical activity programmes are not enough to control blood sugar, insulin treatment, the only drug approved for the control of sugar in pregnancy, will be prescribed.

Q: How does gestational diabetes affect pregnancy and labour?

A: Gestational diabetes increases risk of macrosomia (defined as a birth weight higher than 4kg), hydramnios (increased amniotic fluid volume), urinary infections, preterm labour, Caesarean section and the need to use instruments (forceps, spatulas...) for assisting labour.
No increased risk of congenital malformations has been associated with gestational diabetes.

Q: What are the risk factors for gestational diabetes?

A: Although gestational diabetes sometimes affects women who do not have any known risk factors, it is more likely to occur in women with one or more of the following characteristics: the woman has relatives with diabetes mellitus, she is aged over 35 years old, she is obese, she has had gestational diabetes during a previous pregnancy or she has given birth to a newborn weighing more than 4 kg.

Q: What causes gestational diabetes?

A: Insulin is the hormone responsible for glucose entry into cells. During pregnancy, certain hormones necessary for the development of the baby are secreted by the placenta. These hormones reduce the action of insulin in the mother and, to compensate this phenomenon, more insulin is usually produced. When gestational diabetes develops, the body fails to make enough insulin and therefore, the sugar in the blood remains high.