**3. Telemedicine and its applications to diabetes care in pregnancy**

The main applications of telemedicine relate to educating patients to manage their chronic diseases, making it easier for them to contact their healthcare providers, and enable the col‐ lection of information and its transfer to clinical databases. ICT can help in the management of diabetic patients by providing additional clinical support, which is now increasingly diffi‐ cult to achieve in the classical face-to-face interaction due to the limited health resources available (Lapolla A, 2011). The most encouraging technology nowadays is teleconsultation, involving telemonitoring schemes that include asynchronous exchanges between patients and their healthcare providers (e.g. e-mails, text messages on mobile phones, automated messaging, or other methods requiring no face-to-face contact), or synchronous communica‐ tions in the form of face-to-face contact using videoconferencing equipment (television, digi‐ tal camera, webcam, videophone) to connect healthcare providers to one or more patients at the same time, also for the purpose of providing education and training (Kern J, 2006).

These systems are designed basically as a means to improve the quality of care through clos‐ er communications between patients and professionals, in an effort to create a more dynam‐ ic and motivating exchange, involving patients to a greater extent in their own care, and making the monitoring of their disease more compatible with their lifestyle (Verhoeven F, 2007; McMahon GT, 2005). This applies in particular to the management of diabetes (Franc S, 2011) and especially in pregnancy complicated by diabetes, given the drastically reduced time available for examining and educating these patients who need short-term adjustments to their therapy and reassurance concerning an appropriate diet, as well as routine care (La‐ polla et al, 2011). Combining the applications of telemedicine with programs for managing diabetes in pregnancy seems to be a fundamental step to combine the need for an intensive approach to these patients with the containment of the associated costs.

Studies evaluating these applications must take into account both clinical aspects, including those related to the effects on quality of life, both behavioral outcomes and finally economic/ social issues, especially related to health care costs (Verhoeven F et al, 2010).

#### **3.1. Evidence of the use of telemedicine in pregnant women with type 1 diabetes**

Wojcicki et al analyzed the effectiveness of an automated telematic intensive care system for transferring all of patients' glucose measurements taken during the course of a day to a cen‐ tral clinical unit. The patients' mean blood glucose (MBG) and an indicator of glucose varia‐ bility (the J-index) were used to monitor their glycemic control. The authors demonstrated a better glycemic control in the experimental group by comparison with a control group, based on the average differences in the patients' MBG and J indices, calculated weekly (ΔMBG = -3.2 +/- 4.3 mg/dL, p = 0.0016, ΔJ = -1.4 +/- 2.3, p = 0.0065). They also found a ten‐ dency for a better glycemic control in patients with a lower intelligence quotient (IQ < 100) supported by the telematic system by comparison with all the other groups of patients, though this difference lacked statistical significance. The telematic intensive care system im‐ proved the efficacy of diabetes treatment during pregnancy (Wójcicki JM, 2001).

sulin therapy (Landon MB, 2011). Using telemedicine can facilitate the management of pregnancy complicated by diabetes, being applicable to all the above-mentioned areas of in‐ tervention. The great challenge now is to demonstrate the efficacy of this innovative tool in

The main applications of telemedicine relate to educating patients to manage their chronic diseases, making it easier for them to contact their healthcare providers, and enable the col‐ lection of information and its transfer to clinical databases. ICT can help in the management of diabetic patients by providing additional clinical support, which is now increasingly diffi‐ cult to achieve in the classical face-to-face interaction due to the limited health resources available (Lapolla A, 2011). The most encouraging technology nowadays is teleconsultation, involving telemonitoring schemes that include asynchronous exchanges between patients and their healthcare providers (e.g. e-mails, text messages on mobile phones, automated messaging, or other methods requiring no face-to-face contact), or synchronous communica‐ tions in the form of face-to-face contact using videoconferencing equipment (television, digi‐ tal camera, webcam, videophone) to connect healthcare providers to one or more patients at the same time, also for the purpose of providing education and training (Kern J, 2006).

These systems are designed basically as a means to improve the quality of care through clos‐ er communications between patients and professionals, in an effort to create a more dynam‐ ic and motivating exchange, involving patients to a greater extent in their own care, and making the monitoring of their disease more compatible with their lifestyle (Verhoeven F, 2007; McMahon GT, 2005). This applies in particular to the management of diabetes (Franc S, 2011) and especially in pregnancy complicated by diabetes, given the drastically reduced time available for examining and educating these patients who need short-term adjustments to their therapy and reassurance concerning an appropriate diet, as well as routine care (La‐ polla et al, 2011). Combining the applications of telemedicine with programs for managing diabetes in pregnancy seems to be a fundamental step to combine the need for an intensive

Studies evaluating these applications must take into account both clinical aspects, including those related to the effects on quality of life, both behavioral outcomes and finally economic/

Wojcicki et al analyzed the effectiveness of an automated telematic intensive care system for transferring all of patients' glucose measurements taken during the course of a day to a cen‐ tral clinical unit. The patients' mean blood glucose (MBG) and an indicator of glucose varia‐ bility (the J-index) were used to monitor their glycemic control. The authors demonstrated a better glycemic control in the experimental group by comparison with a control group, based on the average differences in the patients' MBG and J indices, calculated weekly

approach to these patients with the containment of the associated costs.

social issues, especially related to health care costs (Verhoeven F et al, 2010).

**3.1. Evidence of the use of telemedicine in pregnant women with type 1 diabetes**

terms of maternal-fetal outcome and an advantageous cost/benefit ratio.

66 Telemedicine

**3. Telemedicine and its applications to diabetes care in pregnancy**

Ladyzynsky et al developed a system for supporting intensive insulin treatment in pregnant women with type 1 diabetes. The system consists of a patient teletransmission module (PTM) and a central clinical control unit (CCU). The PTM comprises a box containing a blood glucose meter and an electronic logbook, a modem for dial-up internet or a cellular phone set. The CCU consists of a PC with a modem and DIAPRET software – a dedicated program designed to monitor the intensive insulin treatment. The system was tested on 15 pregnant type 1 diabetic women for 166±24 days. Its total effectiveness was 69.3±13.0% and its technical effectiveness was 91.5±6.1%, and was not significantly influenced by the pa‐ tients' IQ, formal education or place of residence, while it turned into a better metabolic con‐ trol (Ładyżyński et al, 2001).

The same authors also assessed the influence of the greater frequency of data reporting on diabetic patients' metabolic control. Data were reported via a home telecare system that stored blood glucose levels and was integrated with a simple electronic logbook. The data collected by patients were automatically transmitted via the telephone network every night. The study population consisted of 30 patients with type 1 diabetes, who were randomly al‐ located to the home telecare group or a control group. The control group's treatment was based on clinical examinations performed every three weeks. For the home telecare group, the data recorded by patients were transmitted to the hospital daily, enabling doctors to in‐ tervene more frequently. The average duration of the study was 180 days (standard devia‐ tion, SD 22) in the home telecare group and 176 days (SD 16) in the control group. The mean level of metabolic control and the insulin dose adjustment patterns were very similar in the two groups despite the much greater (15-fold) reporting frequency in the home telecare group. The data collected by patients were not fully usable, mainly because of an excessively high within-day variability in glycemic control and the high workload for the hospital staff performing the daily data analysis. On average, for the home telecare group, the patients' data were collected about 0.7 times per day (i.e. 15 times more often than in the case of rou‐ tine treatment), although average metabolic control was found only slightly better for the home telecare group than for controls, and the number of adjustments to patients' insulin doses was very similar in the two groups. Both general compliance issues (relating to the considerable effort needed to analyze the daily data) and clinical problems (e.g. a high intraday glycemic variability) probably contributed to the lack of any significant differences be‐ tween the two groups. These findings prompted the authors to conclude that remote systems used at home by patients with type 1 diabetes on intensive insulin therapy im‐ proves their glycemic control, but needs to support real-time data transmission and be com‐ bined with appropriate data analysis and subsequent decision-making for it to achieve any real improvement in the quality of care (Ładyżyński et al, 2007).

Di Biase et al also investigated whether telemedicine could be useful in the management of pregnant type 1 diabetic women. A fully automated system (the DIANET system) was used and 20 type 1 pregnant women took part in the study: 10 were treated using the telemedi‐ cine system, the other 10 using the conventional approach. The DIANET system was adopt‐ ed at 4 different times, termed as: "entry" (at 9.5 weeks of gestation); "basal" (9.5-16.8 weeks); "1st month" of investigation; and "end" (near delivery). All the women adopted in‐ tensified insulin administration protocols. Judging from the profiles of the women's abso‐ lute blood glucose values, the DIANET ensured a better metabolic control than the conventional approach. These results were associated with higher insulin doses being used by the women in the DIANET group. There was a significant reduction in both groups' hy‐ poglycemic episodes at the "end", "1st month" and "basal" study points by comparison with the situation at "entry". Based on their results, the authors suggest that telemedicine (DIA‐ NET) is a practical way to provide specialist care in pregnancy (Di Biase et al, 1997)

Clinical and non-clinical outcomes were evaluated: the former included mode and timing of delivery, macrosomia, maternal and fetal morbidity; the latter were deduced using question‐ naires, i.e. the CES-D for depression, the SF-36 for health-related quality of life (QoL), the Stress and Distress or the impact of diabetes. The telemedicine GDM group achieved a bet‐ ter metabolic control in the third trimester (p=0.008) and a lower rate of cesarean sections (p=0.02) and macrosomia (p=n.s.). The women in the telemedicine group also had lower lev‐ els of frustration and concern about their diabetes, and a better acceptance of their diabetic condition. A strength of this study lies in that the authors adopted a straightforward teleme‐ dicine system (using the telephone) that was easy for all patients to handle, demanding no

Better Ways to Cope with Increasingly Common Diseases: The Impact of…

http://dx.doi.org/10.5772/57018

69

Pèrez-Ferre et al studied 97 women with GDM to ascertain the feasibility of a telemedicine system based on the Internet and text messaging, and its influence on delivery and neonatal outcomes (HbA1c values < 5.8%, normal vaginal deliveries, and LGA babies). Forty-eight women attended traditional face-to-face visits and 49 formed the experimental group using the telemedicine system to send capillary glucose data and short text messages, receiving professional feedback weekly. There was no significant difference between the two groups in terms of the outcomes considered, despite the experimental group's significantly reduced number of visits to the clinic, particularly among the insulin-treated women. The authors concluded that the telemedicine-based system achieved similar pregnancy, delivery and newborn outcomes to the traditional treatment approach, while significantly reducing the

More recently, the same authors demonstrated that, compared with a control group, a tele‐ medicine group reduced the number of unscheduled face-to-face visits by 62% (and by 82.7% for the subgroup of insulin-treated patients), improving patient satisfaction and ach‐

In a study by Homko et al, women with GDM were randomized to either an Internet group (n = 32) or a control group (n = 25). Patients in the Internet group were given computers and/or Internet access as necessary. A website was established for recording glucose levels and for communications between patients and the health care team. Women in the control group kept paper logbooks, which were reviewed at each prenatal visit. Maternal feelings about diabetes self-efficacy were assessed at study entry and again before delivery. Women in the Internet group accessed the system and sent a mean 21.8 (±16.9) sets of data. There was no difference between the two groups' fasting or post-prandial blood glucose levels, al‐ though more women in the Internet group were on insulin therapy (31% vs. 4%; P <0.05). There were also no significant differences in pregnancy and neonatal outcomes between the two groups. The women in the Internet group demonstrated a significantly stronger sense of self-efficacy at the end of the study. The potential benefits of monitoring blood glucose via the Internet in indigent women with GDM was limited by their infrequent use of the teleme‐ dicine system. While using the system was not associated with better pregnancy outcomes, the diabetic women in the telemedicine group did experience a better sense of psychosocial

ieving comparable pregnancy and newborn outcomes (Pérez-Ferre N, 2010).

IT expertise or computer literacy (Dalfrà et al, 2009).

need for outpatient clinic visits (Pérez-Ferre N, 2009)

self-efficacy (Homko CJ, 2007).

Frost et al used a remote data management system (CareLink; Abbott-MediSense, New Bed‐ ford, MA) to monitor 11 pregnant women with type 1 diabetes (all on intensive insulin ther‐ apy) from the 15th gestational week onwards, comparing them with controls receiving routine diabetes care, which consisted of visits every 2-3 weeks. The controls were 10 preg‐ nant women with type 1 diabetes matched for age, history of diabetes, and expertise with self-monitoring and insulin regimens. The average time between two visits was 3.3 weeks for the CareLink group and 2.9 weeks for the control group. There was an improvement in HbA1c in both the CareLink group (from 6.1±1.0 to 5.4±0.3) and the control group (from 6.2±0.8 to 5.7±0.6), though the differences were not statistically significant. MBG levels drop‐ ped in the CareLink group from 141±90 to 110±18 mg/dl, and fasting glucose from 111±17 to 101±23 mg/dl (p <0.05). Glycemic variability was also significantly reduced in both groups: the standard deviation of the MBG levels in individual patients fell from 51.6 to 44.4 mg/dl (p <0.01), while for mean fasting blood glucose the SD decreased from 41.4 to 31.0 mg/dl. There was no significant reduction in the number of hypoglycemic episodes in either of the groups. The authors concluded that the system was easy to use and helpful in the treatment of diabetic women during pregnancy, enabling fewer outpatient visits. This aid would therefore be particularly suitable for women who have difficulty attending the prescribed regular check-ups at the clinic (Frost et al, 2000).

#### **3.2. Evidence of the use of telemedicine in pregnant women with GDM**

Dalfrà et al enrolled a total of 235 pregnant women (203 with GDM and 32 with type 1 dia‐ betes mellitus) and assigned them sequentially to a telemedicine or a control group. Women with type 1 diabetes were enrolled in the study immediately after conception, while women with GDM were included one week after their GDM was diagnosed (at a mean 28±1 weeks of gestation). The pregnant women in the telemedicine group were trained to monitor their blood glucose levels with a glucometer (One Touch Ultra-Lifescan) and send their blood glucose profiles to Glucobeep by means of a standard phone call. These women also attend‐ ed 1 outpatient visit per month. The women in the control group only had a medical exami‐ nation every two weeks. All patients could contact the physician whenever they wished. Clinical and non-clinical outcomes were evaluated: the former included mode and timing of delivery, macrosomia, maternal and fetal morbidity; the latter were deduced using question‐ naires, i.e. the CES-D for depression, the SF-36 for health-related quality of life (QoL), the Stress and Distress or the impact of diabetes. The telemedicine GDM group achieved a bet‐ ter metabolic control in the third trimester (p=0.008) and a lower rate of cesarean sections (p=0.02) and macrosomia (p=n.s.). The women in the telemedicine group also had lower lev‐ els of frustration and concern about their diabetes, and a better acceptance of their diabetic condition. A strength of this study lies in that the authors adopted a straightforward teleme‐ dicine system (using the telephone) that was easy for all patients to handle, demanding no IT expertise or computer literacy (Dalfrà et al, 2009).

Di Biase et al also investigated whether telemedicine could be useful in the management of pregnant type 1 diabetic women. A fully automated system (the DIANET system) was used and 20 type 1 pregnant women took part in the study: 10 were treated using the telemedi‐ cine system, the other 10 using the conventional approach. The DIANET system was adopt‐ ed at 4 different times, termed as: "entry" (at 9.5 weeks of gestation); "basal" (9.5-16.8 weeks); "1st month" of investigation; and "end" (near delivery). All the women adopted in‐ tensified insulin administration protocols. Judging from the profiles of the women's abso‐ lute blood glucose values, the DIANET ensured a better metabolic control than the conventional approach. These results were associated with higher insulin doses being used by the women in the DIANET group. There was a significant reduction in both groups' hy‐ poglycemic episodes at the "end", "1st month" and "basal" study points by comparison with the situation at "entry". Based on their results, the authors suggest that telemedicine (DIA‐

NET) is a practical way to provide specialist care in pregnancy (Di Biase et al, 1997)

regular check-ups at the clinic (Frost et al, 2000).

68 Telemedicine

**3.2. Evidence of the use of telemedicine in pregnant women with GDM**

Dalfrà et al enrolled a total of 235 pregnant women (203 with GDM and 32 with type 1 dia‐ betes mellitus) and assigned them sequentially to a telemedicine or a control group. Women with type 1 diabetes were enrolled in the study immediately after conception, while women with GDM were included one week after their GDM was diagnosed (at a mean 28±1 weeks of gestation). The pregnant women in the telemedicine group were trained to monitor their blood glucose levels with a glucometer (One Touch Ultra-Lifescan) and send their blood glucose profiles to Glucobeep by means of a standard phone call. These women also attend‐ ed 1 outpatient visit per month. The women in the control group only had a medical exami‐ nation every two weeks. All patients could contact the physician whenever they wished.

Frost et al used a remote data management system (CareLink; Abbott-MediSense, New Bed‐ ford, MA) to monitor 11 pregnant women with type 1 diabetes (all on intensive insulin ther‐ apy) from the 15th gestational week onwards, comparing them with controls receiving routine diabetes care, which consisted of visits every 2-3 weeks. The controls were 10 preg‐ nant women with type 1 diabetes matched for age, history of diabetes, and expertise with self-monitoring and insulin regimens. The average time between two visits was 3.3 weeks for the CareLink group and 2.9 weeks for the control group. There was an improvement in HbA1c in both the CareLink group (from 6.1±1.0 to 5.4±0.3) and the control group (from 6.2±0.8 to 5.7±0.6), though the differences were not statistically significant. MBG levels drop‐ ped in the CareLink group from 141±90 to 110±18 mg/dl, and fasting glucose from 111±17 to 101±23 mg/dl (p <0.05). Glycemic variability was also significantly reduced in both groups: the standard deviation of the MBG levels in individual patients fell from 51.6 to 44.4 mg/dl (p <0.01), while for mean fasting blood glucose the SD decreased from 41.4 to 31.0 mg/dl. There was no significant reduction in the number of hypoglycemic episodes in either of the groups. The authors concluded that the system was easy to use and helpful in the treatment of diabetic women during pregnancy, enabling fewer outpatient visits. This aid would therefore be particularly suitable for women who have difficulty attending the prescribed

Pèrez-Ferre et al studied 97 women with GDM to ascertain the feasibility of a telemedicine system based on the Internet and text messaging, and its influence on delivery and neonatal outcomes (HbA1c values < 5.8%, normal vaginal deliveries, and LGA babies). Forty-eight women attended traditional face-to-face visits and 49 formed the experimental group using the telemedicine system to send capillary glucose data and short text messages, receiving professional feedback weekly. There was no significant difference between the two groups in terms of the outcomes considered, despite the experimental group's significantly reduced number of visits to the clinic, particularly among the insulin-treated women. The authors concluded that the telemedicine-based system achieved similar pregnancy, delivery and newborn outcomes to the traditional treatment approach, while significantly reducing the need for outpatient clinic visits (Pérez-Ferre N, 2009)

More recently, the same authors demonstrated that, compared with a control group, a tele‐ medicine group reduced the number of unscheduled face-to-face visits by 62% (and by 82.7% for the subgroup of insulin-treated patients), improving patient satisfaction and ach‐ ieving comparable pregnancy and newborn outcomes (Pérez-Ferre N, 2010).

In a study by Homko et al, women with GDM were randomized to either an Internet group (n = 32) or a control group (n = 25). Patients in the Internet group were given computers and/or Internet access as necessary. A website was established for recording glucose levels and for communications between patients and the health care team. Women in the control group kept paper logbooks, which were reviewed at each prenatal visit. Maternal feelings about diabetes self-efficacy were assessed at study entry and again before delivery. Women in the Internet group accessed the system and sent a mean 21.8 (±16.9) sets of data. There was no difference between the two groups' fasting or post-prandial blood glucose levels, al‐ though more women in the Internet group were on insulin therapy (31% vs. 4%; P <0.05). There were also no significant differences in pregnancy and neonatal outcomes between the two groups. The women in the Internet group demonstrated a significantly stronger sense of self-efficacy at the end of the study. The potential benefits of monitoring blood glucose via the Internet in indigent women with GDM was limited by their infrequent use of the teleme‐ dicine system. While using the system was not associated with better pregnancy outcomes, the diabetic women in the telemedicine group did experience a better sense of psychosocial self-efficacy (Homko CJ, 2007).

In a subsequent study, these authors tested a more advanced telemedicine system, which in‐ cluded automated reminders to patients to send their data. Eighty GDM women were randomized to join an intervention group using telemedicine to send blood glucose record‐ ings obtained 4 times a day via the Internet or telephone, or a control group using paper log‐ books. Although there were no significant differences in the outcomes considered (glucose control and birth weight of offspring), this type of telemedicine approach improved the con‐ tact between patients and healthcare professionals, making the use of technology for moni‐ toring of diabetes in pregnancy more familiar (Homko CJ, 2012).

Finally, in GDM patients one study showed that integrating telemedicine applications and involvement of the nursing staff turns into better fetal outcome and adhesion to glucose monitoring. With this respect Ferrara et al demonstrated that higher referral frequency to telephonic nurse management for gestational diabetes mellitus decreased risk of macroso‐ mic infant and increased postpartum glucose testing (Ferrara et al, 2012).
