GOThenburG - SweDen · Gothenburg, Sweden, from 16th to 19th October 2013. 1 Telemedicine in diabetes management: new perspectives h i G h l i G h T T S As shown above, telemedicine

18 th October 2 0 1 3

October 16th-19th

Telemedicine in diabetes management: new perspectives

A.Menarini Diagnostics Satellite Symposium

GOThenburG - SweDen

hiGhliGhTS

October 16th-19th 18 th October 2 0 1 3


A.Menarini Diagnostics Satellite Symposium

Chairman: Prof. Thomas Danne (Germany)

Drawn from the speeches by

Prof. Thomas Danne (Germany)Chief Physician, General Pediatrics Diabetes, Endocrinology, Clinical Research Diabetes Centre for Children and Young, AUF DER BULT, Children and Youth Hospital, Hannover.

Dr. Gert Jan van der burg (The Netherlands)Pediatrician, Medical Manager Cure Division, Gelderse Vallei Hospital.

Prof. Veselin Škrabić (Croatia)Professor at School of Medicine - University of Split Pediatrician - endocrinologist diabetologist at Unit of Neuroendocrinology, De-partment of Pediatrics, University Hospital of Split. Professor at School of Medicine - University of Mostar – Bosnia et Hercegovina.

Dr. ivonne Sponzilli (Italy)Regional Centre for Children and Adolescents with Diabetes, Department of Paediatrics, University Hospital of Parma, Parma, Italy.

Supported by A. Menarini Diagnostics, held duringthe international Society for Pediatric and Adolescent Diabetes (iSPAD) conference, Gothenburg, Sweden, from 16th to 19th October 2013.

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HIGHLIGHTsTelemedicine can be particularly useful to enhance communication

between the diabetes team and children with type 1 diabetes

As shown above, telemedicine can be defined as “telecommunication and information tech-nologies in order to provide clinical health care at a distance”. Telemedicine helps eliminate distance barriers and can improve access to medical services that would often not be consi-stently available in distant rural communities. It is also used to save lives in critical care and emergency situations. The increasing spread of mobile phones and smartphones, espe-cially among children and adolescents, has facilitated the implementation of telemedicine, which is now becoming more and more used in different clinical settings. This also applies to paediatric diabetes, a field in which telemedicine can be particularly useful to enhance communication between children with type 1 diabetes mellitus (T1DM) and the diabetes team. T1DM is characterised by deficient insulin production. It requires accurate blood glu-cose monitoring and daily administration of insulin to prevent the acute and long-term detri-mental consequences of diabetes. Integration of new technologies in the multidisciplinary management of diabetic children could help both the routine and emergency management of these patients, in whom diabetic ketoacidosis (DKA) is still an important cause of death.

Figure 1. Definition of telemedicine according to Wikipedia.

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International Society for Pediatric and Adolescent Diabetes (ISPAD)

HIGHLIGHtS Self-blood glucose monitoring allows tighter blood glucose control and

reduces the long-term risks of diabetic complications

People with T1DM should keep a record of the blood glucose readings in a glucose-mo-nitoring diary, in order to adjust the insulin dose based on glucose values and help the diabetes health care team individualise the therapeutic strategy. Self-blood glucose moni-toring allows tighter blood glucose control, which decreases the long-term risks of diabetic complications. In fact, there is a favourable association between the number of blood glu-cose measurements and haemoglobin A1c (HbA1c), a parameter that reflects glycaemic control of the previous 2-3 months. Nevertheless, children and adolescents with diabetes often fail to regularly fill their glucose diaries. Several factors contribute to low frequency of blood glucose monitoring during adolescence, including developmental changes (e.g., in-creased autonomy) and decreased family involvement in diabetes management. Very often patients fill their diaries just before meeting the diabetologist: a glucose diary like the one in Figure 2, without coffee or blood stains, and with “beautiful” handwriting should make a physician suspicious. Telemedicine could strongly impact the management of young people with diabetes, who are prone to use new technologies and very familiar with mobile phones/smartphones.

Figure 2. A traditional blood glucose monitoring diary. Blood glucose values are reported in mmol/L.

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HIGHLIGHTsThanks to the GlucoLog® Mobile app, the diabetes team is provided

with reliable data, and patients can receive remote guidance on diabetes management.

Dr. G.J. van der Burg (NE) and his diabetes team undertook a pilot study with the aim of assessing the effectiveness of blood glucose values transfer by smartphone in a clo-sed-loop diabetes support system, and the effect of this system on glucose management in children. In this close-loop system, after the patient measures his/her blood glucose with an A. Menarini Diagnostics glucose meter such as the GlucoMen LX PLuS, data are transferred from the meter to the GlucoLog® Mobile app on the patient’s mobile, and au-tomatically synchronized with a web-based personal health record. The personal health record is linked to the electronic medical record system in the hospital, where diabetes nurses can access the data. Subsequently, diabetes nurses enter a feedback into the electronic medical record system. The information is then transferred to the personal health record and is also sent to the patient’s smartphone (Figure 3). In this way, the dia-betes team is provided with reliable data, and patients can receive remote guidance on diabetes management, which could enhance adherence to self-blood glucose monitoring and T1DM treatment.

Figure 3. The GlucoLog® Mobile app allows transfer of data from an A. Menarini Diagnostics glucose meter to the patient’s mobile. Data are then sent from the mobile to a web-based personal health re-cord (PHR) and to the patient’s electronic medical record (EMR) in the hospital, where diabetes nurses can readily analyse them and provide patients with a feedback.

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HIGHLIGHtS Data were transferred from the GlucoMen® LX Plus meter to the

smartphone, then to the personal health record and to the electronic medical record via a VPN connection

Thirty patients with T1DM (14 males and 16 females) were enrolled in this pilot study, whi-ch was conducted in the Netherlands. Mean age was 15 years (11-20 years), and mean duration of diabetes 4.7 years (Figure 4). All patients were on multiple dose injection (MDI) therapy, using an insulin pen. HbA1c levels ranged from 42 to 110 mmol/mol (6 to 12.2%) with a mean value of 68 mmol/mol (8.3%). The only exclusion criterion was insulin pump therapy.All patients were provided with an A. Menarini Diagnostics GlucoMen® LX Plus glucose me-ter, an Android-based smartphone and an individual personal health record account. Data were transferred from the meter to the smartphone via a Bluetooth connection, then to the personal health record as encrypted data and to the electronic medical record (Norma®) via a VPN connection.Instructions on the devices and the personal health record account were given to groups of patients by diabetes nurses. During the test period, a help-desk was available to patients for solving technical problems. These problems were logged and a frequently asked que-stions (FAQ) database was compiled with the most common errors or problems and their solutions.

Figure 4. Baseline characteristics of study subjects. T1DM, type 1 diabetes mellitus. MDI, multiple daily injections.

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HIGHLIGHTsPatients encountered minimal technical problems with the whole system.

Mean HbA1c decreased from 68 mmol/mol (8.3%) to 65 mmol/mol (8.1%)

Before the test period and after 3 and 6 months, HbA1c values were recorded and all patients and diabetes nurses filled out questionnaires on both quantitative and qualitative items relative to the use of separate parts of the system.Four patients did not complete the study (Figure 5). The mean number of blood gluco-se measurements (nBG) was 25 ± 10 per week. There was no significant change in the number of measurements after 3 or 6 months. Mean HbA1c decreased from 68 mmol/mol (8.3%) to 65 mmol/mol (8.1%). An inverse correlation was found between nBG and HbA1c, i.e. the higher the number of glucose measurements, the lower (better) the HbA1c values. No correlation was observed between nBG and age, nBG and duration of the diabetes, or nBG and gender.Overall, patients encountered minimal technical problems with the whole system during the first 6 months of the study, and human errors were the cause of these problems in the majo-rity of cases. Evaluation of the usability of the system was positive, and satisfaction rates were high among both patients and diabetes nurses. uniformity of digital data, as opposed to the diversity that characterises traditional glucose diaries, highly facilitated the workflow of the healthcare professionals.

Figure 5. Study results. nBG, number of glucose measurements. HbA1c, haemoglobin A1c.

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HIGHLIGHtS Adolescents with T1DM have difficulties in accepting their illness, and

are reluctant to regularly check and record their blood glucose values

The main task of each diabetes team member is to improve adherence to treatment regi-mens and to achieve better glycaemic control. This is not always easy in adolescents with T1DM, who have difficulties in accepting their illness, and are reluctant to regularly check and record their blood glucose values. Dr. V. Škrabić recognised that, despite the develop-ment of new insulin regiments and the improvement of insulin delivery methods and strate-gies to enhance diabetes care, the overall metabolic control of young patients with T1DM managed at the university Hospital of Split (HR) has improved unsatisfactorily (Figure 6).Dr. V. Škrabić and his team took advantage of the healthcare information and communica-tion technologies developed by A. Menarini Diagnostics to set up the MENARI-ST project, with the aim of achieving better glycaemic control rates in these patients. The specific objective of the project was to assess the feasibility and the effect of the implementation of mobile technology in the management of children and adolescents with T1DM.

Figure 6. Diabetes management at University Hospital Center of Split (HR) over the past decade.

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HIGHLIGHTsTransfer of data from the GlucoLog® Lite Mobile app to the GlucoLog®

Professional software enabled healthcare professionals to examine glycaemic profiles and give a feedback and indications on insulin dosing

The effects on both short-term glycaemic control and quality of life were evaluated. Patients were instructed by a nurse on how to transfer data from their Glucofix miò Plus meters to the GlucoLog® Lite. mobile app on their smartphones via the bluetooth GlucoLog® B.T. De-vice. Data were sent from the GlucoLog® Lite to the GlucoLog® Professional software used in the hospital once a week, which enabled healthcare professionals to examine glycaemic profiles and provide patients and/or their parents with a feedback and indications on insulin dosing. HbA1c levels were recorded at baseline and after 2, 4 and 6 months. Interviews and questionnaires were used to collect information on patients’ opinions on the project. Nine female and eleven male patients with inadequate glycaemic control and erratic self-blo-od glucose monitoring participated in the project (Figure 7). Mean age was 13.4 years, and mean duration of disease 5.3 years. Most children were on a multiple dose insulin injection regimen, whereas 6 participants were on continuous subcutaneous insulin infusion. Base-line HbA1c values ranged from 6.8 to 10.0% (mean: 8.0%).

Figure 7. Baseline characteristics of study subjects.

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HIGHLIGHtS Both parents and children thought that the MENARI-ST project was of

great support and encouragement in their lives

Six months after the start of the project, a reduction in HbA1c values was observed in the majority of patients (55%). Mean HbA1c values decreased from 8.0% to 7.9% (Figure 8), although the change from baseline was not statistically significant. It is likely that increasing the number of patients would lead to statistical significance. The mean number of daily glucose measurements at the end of the six months ranged from 3 to 10, with a mean of 5.14 (Figure 8). Almost half of the patients measured their blood glucose more than 6 times a day. Young patients enrolled in the project, even the teenagers, were more motivated to perform self-blood glucose monitoring, and being in contact with the diabetologist more fre-quently than usual was associated with high patient satisfaction. Furthermore, participants felt rewarded for being involved in the project. Both parents and children thought that the project, by allowing closer interactions with the diabetes team, was of great support and encouragement in their lives. Diabetes is a chronic, lifelong disease that strongly impacts quality and duration of patients’ lives. This is particularly true in patients with T1DM, who are diagnosed at a young age and whose management is complicated by complex interactions between physical and psychosocial factors that patients themselves, parents and healthca-re professionals often find difficult to manage.

Figure 8. Study results. HbA1c values (left) and number of blood glucose measurements (right) at baseline and at the end of the project.

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HIGHLIGHTsThe mobile-based telecommunication system GlucoLog® Lite has the

potential to help families in the control of diabetes and may facilitate the work of the diabetes team

Therefore, interventions aimed at improving and individualising diabetes care may lead to better outcomes and increased patient satisfaction. In order to evaluate the impact of mobile technology on health-related quality of life, children and caregivers (parents or legal guardians) participating in the MENARI-ST project were asked to complete the Paediatric Quality of Life Inventory (PedsQL) Generic Core Sca-le. This tool allows measurement of the core dimensions of health, such as physical and psychosocial health. As shown above, there was a statistically significant (p=0.025) impro-vement in the Physical Health Summary Score, which increased by 10 points at the end of the 6-month period (Figure 9). Similarly, there was a trend towards an improvement in both the Psychosocial Health Summary Score and the Total Scale Score, although these results did not reach statistical significance, probably due to the relatively small sample of patients. Overall, the results of the MENARI-ST project suggest that the mobile-based telecommuni-cation system GlucoLog® Lite has the potential to help families in the control of diabetes and may facilitate the work of the diabetes team, especially in situations where long-distance travel would be needed for the patient to reach the hospital or the Diabetes Centre.

Figure 9. Study results. Physical Health Summary score at baseline and after six months. Mdn, me-dian; IQR, interquartile range; Q1, first quartile; Q3, third quartile.

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HIGHLIGHtS DKA is the most serious metabolic emergency in paediatrics, and

therefore requires timely and specific management

When insulin is not sufficient to meet the body’s needs, tissues cannot uptake and use glucose as a fuel; therefore, cells switch from glucose to fat metabolism and start to break down fatty acids to produce energy, a process that results in the production of ketones, mainly acetoacetate, acetone and beta-hydroxybutyric acid. When levels of ketones in-crease, DKA develops. DKA is the most serious metabolic emergency in paediatrics, and therefore requires timely and specific management. Precise intravenous fluid calculations, accurate dosing of insulin, frequent variations of therapy and hourly clinical and laboratory monitoring are necessary for managing DKA. This process is prone to errors that could lead to serious adverse events or even death. Paediatricians of the Children university Hospital “Pietro Barilla” (Parma, Italy), in collabo-ration with A. Menarini Diagnostics, set up a project to develop a computer-based program that supports physicians in the emergency management of DKA (Figure 10). The Glucolog® DKA Expert software used in the project elaborates clinical and laboratory parameters ente-red by physicians (Figure 10) and generates orders based on the institutional protocol used for DKA management in the Emergency Department of the hospital.

Figure 10. Aim of the project. DKA, diabetic ketoacidosis; BG, blood glucose; UG, urinary glucose; ECG, electrocardiogram; BP, blood pressure; GCS, Glasgow Coma Scale.

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HIGHLIGHTsA computer-based program could help reduce errors by providing

timely, point-of-care information that can guide healthcare providers in prescribing choices

The GlucoLog® DKA Expert software also provides a series of alerts in case of electrolytes derangement, excessively rapid decrease in blood glucose levels, incorrect insulin dosage calculation and cerebral oedema (Figure 11). A computer-based program could be espe-cially helpful in small hospitals with a low volume of patients admitted for DKA, in which DKA is not seen as frequently as other conditions routinely managed by emergency physicians. Furthermore, it has been reported that 5.7% of handwritten inpatient orders and as high as 57% of handwritten outpatient orders contain errors. A computer-based program could help reduce these errors by eliminating illegibility of handwritten orders, ensuring comple-teness in prescribing fields and providing timely, point-of-care information that can guide healthcare providers in prescribing choices, avoid potential errors and improve adherence to guidelines.1 The effect of the implementation of the GlucoLog® DKA Expert software was preliminary tested in 10 patients admitted for DKA to the Children university Hospital “Pie-tro Barilla”.

Figure 11. The GlucoLog® DKA Expert software provides a series of alerts in case of electrolytes de-rangement, excessively rapid drop in blood glucose levels, incorrect insulin dosage calculation and cerebral oedema.

1 Abramson EL, Kaushal R. Pediatr Clin North Am. 2012;59:1247-55.

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HIGHLIGHtS According to both physicians and nurses, the GlocoLog® DKA Expert

software was user-friendly and a helpful tool for the management of DKA.

No major differences were found between the two methods (Figure 12). In two cases, the insulin dose indicated by the software was slightly higher than the dose prescribed by phy-sicians, possibly due to a more cautious approach adopted by the latter. According to both physicians and nurses, the new computerized method was user-friendly and represented a helpful tool for the management of DKA. It should be noted that the GlucoLog® DKA Expert software allows hourly monitoring of the patients’ ketonaemic status through the 3-β-hydroxybutyrate (β-HBA) assay. β-HBA is the main ketone in the circulation during DKA. High values of β-HBA have been associated with longer time to resolution of DKA, and β-HBA dosage informs on the definitive resolution of ketosis many hours in advance compared with the urine keton bodies test.2 It has also been suggested that he β-HBA assay reduces monitoring costs and accelerates the discharge of the patient from the intensive care unit.3 As such, β-HBA measurement appears to be a particularly useful tool in the management of DKA.

Figure 12. Study results. DKA, diabetic ketoacidosis.

2 Vanelli M, Chiarelli F. Acta Biomed. 2003;74:59-68.3 Vanelli M, Chiari G, Capuano C. Diabetes Care. 2003;26:959.

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HIGHLIGHTs

Clarity and reliability of digital data improve the efficiency of the workflow of healthcare professionals, and may reduce errors in

executing physician orders

The GlucoLog® DKA Expert software met with high appraisal from physicians, residents and nurses (Figure 13). Physicians, in particular, reported that introducing the software in clinical practice led to a reduction in stress and anxiety associated with DKA management and an improvement in communication among coworkers. In summary, new technologies such as the GlucoLog® Mobile and the GlucoLog® Lite apps allow better communications between patients and medical staff, are associated with high patient satisfaction and empower patients in closer monitoring of their blood glucose levels, which could help prevent high glycaemic variability. Larger studies are needed to confirm the favourable effects of these tools on glycaemic control. Clarity and reliability of digital data improve the efficiency of the workflow of healthcare professionals, and may reduce errors in executing physician orders. By providing valuable support in both calculations and clinical decision making, the novel GlucoLog® DKA Expert software may offer advantages in the emergency management of DKA as compared with conventional handwritten methods.

Figure 13. The GlucoLog® DKA Expert Software was highly appreciated by healthcare professionals involved in the management of diabetic ketoacidosis.

2 Vanelli M, Chiarelli F. Acta Biomed. 2003;74:59-68.3 Vanelli M, Chiari G, Capuano C. Diabetes Care. 2003;26:959.

Key POinTSTelemedicine in diabetes management: new perspectives

Telemedicine helps eliminate distance barriers and can improve ac-cess to medical services

using the Glucolog® lite app and Glucolog® Professional software significantly improved the Physical Health Summary Score

uniformity of digital data provided by the Glucolog® Mobile and the Glucolog® Lite apps highly facilitated the workflow of healthcare professionals.

The Glucolog® DKA expert software elaborates clinical and labora-tory parameters and generates orders based on institutional proto-cols for the management of DKA

Patients enrolled in the MenAri-ST project, even the teenagers, were more motivated to perform self-blood glucose monitoring

introducing the Glucolog® DKA expert software in clinical practice led to a reduction in stress and anxiety associated with DKA mana-gement and improved communications among coworkers.

being in contact with the diabetologist more frequently than usual was associated with high patient satisfaction

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Documents

GOThenburG - SweDen · Gothenburg, Sweden, from 16th to 19th October 2013. 1 Telemedicine in diabetes management: new perspectives h i G h l i G h T T S As shown above, telemedicine