Abstract
Background:
The incidence of gestational diabetes mellitus (GDM)—hyperglycemia with onset or first recognition during pregnancy—is increasing and will have a significant impact on diabetes services. This study aimed to determine the feasibility and acceptability of using telemedicine in the diabetes care of women with GDM and the possibility of replacing alternate (one in every two) diabetes review appointments with telemedicine.
Subjects and Methods:
A feasibility study for a randomized controlled trial was conducted across two sites. Fifty women with GDM were randomized to usual care (n = 26) or usual care plus telemedicine (n = 24). Telemedicine entailed weekly blood pressure and weight measurements and transmission of these data, along with blood glucose readings, for review by the healthcare team. Patients were contacted about these results as necessary. Patients completed questionnaires to measure their satisfaction with telemedicine or blood glucose monitoring. The intervention group and healthcare providers also took part in qualitative interviews. Analysis involved descriptive statistics for the satisfaction questionnaires and framework analysis for the qualitative interviews.
Results:
Eighty-nine percent of patients were satisfied with telemedicine and would use it again. Both HCPs and patients found the equipment easy to use and were positive about using it to replace alternate diabetes review appointments in the future. If used in this way, healthcare providers felt that protected time in which to perform the telemedicine review would be necessary.
Conclusions:
Telemedicine may help meet the growing demand on diabetes services due to increasing numbers of women being diagnosed with GDM.
Introduction
G
The most frequent use of telemedicine in diabetes has been for the transmission of self-monitored blood glucose (SMBG) values from the patient to his or her healthcare provider, 11,12 allowing enhanced patient–caregiver information exchange 13 by facilitating increased frequency of SMBG review. 14 It can be used to reduce the need for outpatient visits by allowing healthcare practitioners to review their patients and to provide them with feedback, remotely. 15,16 Telemedicine therefore has the potential to minimize the burden of GDM on healthcare providers and patients while at the same time increasing access to and efficiency of care. 8
The aim of this study was to determine the feasibility and acceptability of using telemedicine in the diabetes care of women with GDM and the possibility of replacing alternate (one in every two) diabetes review appointments with telemedicine.
The objectives of this study were (1) to assess the potential of telemedicine to provide effective diabetes care for women with GDM and (2) to assess views of patients and healthcare professionals (HCPs) on the acceptability and feasibility of using telemedicine to replace alternate diabetes review appointments.
Subjects and Methods
Trial design
A feasibility study was conducted for a parallel-group randomized controlled trial with 1:1 allocation.
Participants
Women were recruited who had been diagnosed with GDM or impaired glucose tolerance following an oral glucose tolerance test, usually performed at the gestational Week 24–28 screening appointment. 2 Eligibility criteria were the ability to use the telemedicine equipment following training, having sufficient communication abilities (hearing, speech, and language skills) to be fully involved, and being willing to use one of the approved blood glucose meters for the duration of the study. Exclusion criteria were prior diagnosis of type 1 or type 2 diabetes and receiving oral steroid therapy. A previous diagnosis of GDM or impaired glucose tolerance was not an exclusion criterion.
Setting
Subjects were enrolled at two specialist antenatal diabetes clinics, one in Northern Ireland and one in the Republic of Ireland.
Interventions
After informed consent was obtained participants were randomly allocated to either usual care (control group) or telemedicine plus usual care (intervention group).
Control group
At both sites, usual care followed the National Institute for Health and Care Excellence guidelines for the management of GDM or impaired glucose tolerance. 2 Women were asked to monitor their blood glucose values seven times a day (before and after each meal and prebed). They were also asked to attend a specialist diabetes clinic at least every 2 weeks. At this face-to-face review, weight and blood pressure were measured, urinalysis was performed, and glycemia was evaluated, using SMBG records and glycated hemoglobin if available.
Intervention group
In addition to usual care, those in the intervention group were reviewed weekly using telemedicine. Rather than being tailor-made for this study, the telemedicine facilities used were commercially available and in regular use across Northern Ireland. The equipment involved included a set of scales, a blood pressure monitor, a blood glucose meter, and a telemedicine hub. This telemedicine hub was a similar size to the automatic blood pressure meter and had a small screen and three buttons on the front. It facilitated the collection and transmission of telemedicine data and was installed in the patient's home by the telemedicine service provider. Once a week at a prearranged time the hub would activate and remind participants that it was time for their telemedicine session. Women measured weight and blood pressure and sent the stored blood glucose values for the previous 7 days from the meter to the hub. In addition, they responded to three questions: “Have you been taking your insulin?,” “Have you had any hypoglycemic episodes?,” and “Have you had any intercurrent illness?.” Patients answered the questions by pressing a yes or no button on the hub. The information was transmitted by the hub to the service provider's central server where it could be accessed by the patient's HCP. There were two types of hub available: one that used a landline and one that used the mobile phone network. This second type of hub was provided only to those participants who did not have a landline. A Web site was available where patients could review their own data.
One to two days after the patient completed the telemedicine session, the information was reviewed by HCPs. This allowed time for the patient to be reminded to complete the session if necessary. Access to patient information was password protected and limited to those patients for whom an HCP had responsibility. If there were any problems indicated by the telemedicine data, HCPs contacted patients by telephone to discuss any changes that may be needed, in terms of medication, diet, etc., or to arrange a face-to-face review. If there were no problems patients were seen again in person at their next routine appointment.
Outcomes: how and when they were measured
Effective health care
In order to assess the potential of telemedicine to provide effective health care, a range of clinical information was collected in relation to antenatal, obstetric, and neonatal outcomes. The amount of time taken to review a patient in the clinic or using telemedicine was recorded. Although telemedicine review may take less or the same amount of time 12,17,18 as face-to-face review, it can also take significantly longer. 12,13,19,20 The time requirement varies with the technology used and the level of care provided. 17,21,22 If telemedicine review took significantly longer than face-to-face review, then its usefulness might be limited. 23
Antenatal outcomes were recorded at each face-to-face review appointment, whereas obstetric and neonatal outcomes were extracted from patient care records postdelivery.
Patient satisfaction
The intervention group women were asked to complete an adapted version of the Telemedicine Satisfaction and Usefulness Questionnaire.
24,25
(Permission to adapt the questionnaire was provided by S. Bakken.) A version of this questionnaire was also developed for the control group to measure Blood Glucose Monitoring Satisfaction and Usefulness. Participants were asked to complete the questionnaires at 36–38 weeks of gestation, and copies were mailed, along with a stamped return envelope, to any individuals who delivered their baby early. Those in the intervention group were also invited to take part in a semistructured interview, which was recorded with their permission, at 36–38 weeks of gestation. See Supplementary Data for details (Supplementary Data are available online at
Staff satisfaction
All four HCPs who used the telemedicine system were invited to take part in a semistructured interview at completion of the study: a consultant endocrinologist, a midwife specializing in diabetes in pregnancy, and two diabetes specialist nurses. Each interview lasted approximately 15–30 min and was recorded.
Sample size
Fifty participants were recruited, in line with minimum recommended sample size for a feasibility/pilot study 26 while still allowing for some withdrawals.
Randomization
A stratified randomization schedule, with blocks varying from 4 to 6 in length, was generated by B.P.B. using random allocation software for parallel-group randomized trials. 27 J.E.G. enrolled participants and, following informed consent, contacted an independent research secretary who allocated the participant to a group according to the schedule. Allocation concealment was ensured by the fact that the randomization schedule was organized and maintained by individuals who were not involved in recruiting participants.
Blinding
Because of the nature of the intervention it was not possible to blind participants or HCPs.
Analysis methods
Descriptive statistics were used, in IBM SPSS (Meadville, PA) version 20 software, to describe the clinical outcomes and the patient satisfaction questionnaire findings and to compare the amount of time spent reviewing patients at the clinic or using telemedicine.
The “framework” approach to qualitative data analysis was used for both patient and healthcare practitioner interviews. 28 This involves classifying and organizing data according to key themes, concepts, and emergent categories. As a matrix-based analysis method, framework facilitates rigorous and transparent data management 29 and allows an in-depth exploration of the data while maintaining an effective and transparent audit trail. 28
Ethical approval
Ethical approval was obtained from the Office of Research Ethics in Northern Ireland and the Letterkenny General Hospital Ethics Committee.
Results
Data collection occurred over a 17-month period between January 2012 and May 2013. One hundred thirty-one women were referred with GDM before the target of 50 recruits (26 from Site A and 24 from Site B) was met. Of these, 24 were randomized to the intervention group and 26 to the control group (Table 1).
Data are mean ± SD values (n). Body mass index and glucose tolerance test results were not available for all participants.
Two women randomized to telemedicine did not have a landline and had insufficient mobile network coverage in their area to allow data transfer, and one woman in the telemedicine group decided to withdraw after randomization. Outcome data are therefore available for 21 in the intervention group and 26 in the control group (Fig. 1). All analysis was by originally assigned groups.

CONSORT flow diagram.
Effective health care
The main antenatal, obstetric, and neonatal outcomes for each group are shown in Table 2. (See Supplementary Data for additional results.) No differences were expected between the groups, in relation to these outcomes, because of the small sample size and the fact that both groups received the usual level of care. However, if telemedicine were used to replace alternate clinic reviews, it would be important to be able to detect a difference in these outcomes between the two groups. It was therefore important to know that these data could be successfully collected from patient notes, the telemedicine system, blood glucose meters, and patient dairies.
Data are mean ± SD values or n (%) as indicated.
HbA1c, glycated hemoglobin; NICU, neonatal intensive care unit.
The average face-to-face clinic review took 11.7 ± 7.4 min (range, 4–40 min) versus 4.6 ± 5.2 min (range, 1–20 min) for telemedicine.
The patient experience
Potential benefits with telemedicine
Participants at both sites were very happy with the usual GDM care and felt supported by HCPs. The participants identified several potential benefits from replacing alternate clinic reviews with telemedicine review. For example, it would be more convenient than “having to traipse” (participant B24) to clinic every 1–2 weeks. This could be tiring and “monotonous” (participant A1), especially in later pregnancy. It was also frustrating if they were only attending the clinic to see the diabetes specialist yet felt their blood glucose was well controlled. Appointments often meant hours sitting in the hospital. For those who lived in remote areas or who needed to use public transport, this could mean a whole day was spent traveling to and attending the clinic, which was a particular problem for those with children: “when you have a child with you it's too long” (participant A1). Otherwise it was necessary to arrange child care. Working women had the additional problem of absences from work every 2 weeks. These factors could make it difficult for women to attend their appointments.
Using the telemedicine equipment
For the majority of participants the telemedicine session took 5–10 min per week, which was considered acceptable: “Time wise it was just right for me if there was any more work with it I wouldn't get…you know what I mean I wouldn't get round to it…” (participant B12).
Most participants found the telemedicine equipment “very straightforward” (participant A9), “simple” (participant B24), and “easy to use” (participant B19). The telemedicine hub helped participants remember to complete their telemedicine session by lighting up and alerting them. It then talked them through the process so that they “didn't even have to think about anything” (participant A5). Blood pressure and weight were easy to measure, and the communication between these pieces of equipment and the hub was generally efficient: “Cause even my partner couldn't believe it how the scales could send it through to the wee machine and then it talked back to me and the same with the blood pressure” (participant A20).
Participants did, however, encounter some problems. The most common complaint was that the transmission of data by the telemedicine hub to the central server took too long: anything from 10 to 20 min was described as too long, and sometimes it took more than an hour. This was much more common among those who had a mobile hub, and participants suggested that it may be due to the poor mobile phone service in their area: “The signal wouldn't be the greatest like” (participant B20). However, transmission of data could also be slow on the landline hub, especially if the phone was being used for a call at the same time. One participant stopped using telemedicine as she felt the data transmission was just too slow. This highlighted that perhaps the most important factor in terms of whether or not telemedicine would be feasible relates to ease and convenience of use. However overall there was a sense that “it was no problem at all” (participant A4) and “very convenient” (participant B24).
Closer monitoring
Patients felt that with telemedicine they were being monitored more closely than would otherwise have been the case. It was described as “reassuring,” provided a “safety net” (participant A4), or being “kept an eye on” (participant A15).
This was important for patients as diabetes was often new to them, and they could find it difficult to interpret their results: “although I think they're alright, maybe they're not…you just have that added security that they know, you know they're checking on you” (participant A5). The same was true for blood pressure measurements. There was a general awareness among patients that high blood pressure could be a “serious thing” (participant A16) during pregnancy. Having a blood pressure meter at home provided extra reassurance as they could check their blood pressure at any time if they were not feeling well. However, it was difficult for most participants, even those who had had blood pressure explained to them, to understand their measurements: “sometimes my blood pressure was quite low and I didn't know if that was a problem” (participant B19). Knowing that an HCP was checking their blood pressure weekly gave them “peace of mind” (participant A9).
As well as providing reassurance, the weekly review also allowed problems to be detected earlier than would have been the case otherwise. This allowed earlier intervention and improvement in glycemic control: “the nurse talks you through and then it's fine; I mean my levels have come down” (participant A4).
Although some participants “wouldn't necessarily change anything” (participant B19) as a result of telemedicine, others used the information to improve their self-management: “I've found if my weight is going down I would tend to eat a wee bit more, you know, something that would put my weight back up again” (participant A20). The information also provided the women with feedback on their individual response to treatment so that they could get an idea of “where it was working for me or where it was going wrong” (participant B2). There was also a suggestion that telemedicine assisted the women to take more control of their own health such as ensuring that the blood glucose tests were actually performed “instead of just skipping” them (participant B20).
What would be lost
Although the vast majority of participants would use telemedicine again and recommend it to others, they did not want face-to-face appointments replaced completely by telemedicine or even reduced in the event of difficulties in attaining glycaemic targets. Attending clinic provides the opportunity to ask questions: “I like the one to one contact so you can ask questions” (participant B19).
This level of contact was especially important for first-time mothers, as well as those who were struggling with the diagnosis of GDM or who had complications during previous pregnancies.
Satisfaction questionnaires
The satisfaction questionnaire response rates were good at 91% (19/21) in those who received telemedicine and 85% (22/26) in the usual care group. (See Supplementary Data for summaries of the questionnaires.)
The feedback in relation to telemedicine was very positive, with 17 (89.4%) participants agreeing or strongly agreeing that they were satisfied with the telemedicine system and that they would use it again. Participants generally found the equipment easy to use, although a small number had difficulties using the blood pressure monitor (n = 1), the Web site (n = 1), or always being able to trust the equipment to work (n = 2). These findings were supported by the qualitative interviews.
Three (16%) telemedicine users reported that they did not know if their privacy was protected, suggesting that more emphasis should be put on reassuring patients about this aspect of telemedicine.
Blood glucose measurement was seen as the most useful part of telemedicine, followed by weight measurement. This is unsurprising given the training patients receive in measuring and interpreting their blood glucose values and the relative ease of interpreting weight measurements compared with blood pressure measurements.
Feedback in the usual care group was also very positive, with all respondents agreeing or strongly agreeing that they were satisfied with the blood glucose meter. As per telemedicine, one participant felt that she could not always trust the equipment to work.
The healthcare practitioner experience
Learning to use the system
Before the telemedicine service was initiated, staff received training on its use. They felt, however, that this concentrated too much on clerical aspects like how to complete the referral form and instead would have preferred training to concentrate on the different ways patient data could be accessed, manipulated, and presented. By default patient data were presented in a long list, and the HCPs in Site A in particular found this difficult to interpret. With the frequency of SMBG in GDM the long list of blood glucose results produced was just “reams and reams and reams” (HCP AC2) of information. There was also no way to tell which readings were pre- or postmeal values. If the women were not doing all seven tests a day, it was impossible “to look back and see is there a blood sugar previous to try and identify yourself which was the pre and which was the post [meal test]” (HCP AC2). A logbook format would have been preferred, similar to that provided by patient diaries, with values tagged as pre- or postmeal. For the Site A HCPs the poor data format resulted in an increased workload. Despite this they did describe getting “better at looking at them, I got quicker at looking at them” (HCP AC1) as they gained experience. For the Site B HCPs the key to interpreting these lists was “looking for patterns” (HCP BC1). She felt that with experience in interpreting the data in this format “you can really do an efficient piece of assessment” (HCP BC1).
Telemedicine was described as “easy to use” (HCP AC1), but it was “sometimes a little bit slow” (HCP BC1). Whether this was due to the system itself, the Internet connection, or the computers from which it was being accessed was unclear.
How telemedicine would affect clinical practice
For the Site B HCPs telemedicine would reduce the workload, allowing them to spend more time with each patient at clinic as “you wouldn't be rushing cause you realize there's so many behind her” (HCP BC2). In comparison, the Site A HCPs foresaw that telemedicine would increase their workload. Despite this, the Site A HCPs still thought that telemedicine “would be beneficial for the patients” (HCP AC1). They were well aware of the difficulties for women of attending hospital visits on a frequent basis and that telemedicine “would cut down on maybe the patients running up here” (HCP AC1). To have to take the whole day off work and then “to come to clinic and be told you're doing everything right…potentially for her is, you know, it just has created a lot of excess stress that perhaps she doesn't need, whereas a phone call and support with telemedicine would have give her the option to, to not be seen as frequently” (HCP AC2).
Communication with patients
The only reported disadvantage of telemedicine for staff was that the opportunity to talk to patients directly was lost. When reviewing a patient at clinic “you are able to discuss what is happening. There is a lot of limitation with [telemedicine] just being results and not the holistic patient” (HCP AC2). Although the information provided by the questions on medication use, hypoglycemic episodes, and general health was useful and helped HCPs “make a good judgment” (HCP BC1), it was minimal. In comparison, the additional information provided by simply talking to patients can play an important part when making management decisions: “you get bits of additional information from chatting to them so if you were looking at their sugars and you were chatting you might actually identify ‘oh yes that's why that was high or that's why that was low’ and they may be once off things that wouldn't influence you changing the insulin” (HCP BC1).
Using telemedicine in the future
By far the most important requirement for successful future use of telemedicine, from a HCP's point of view, was the need to have protected time in which to review telemedicine information. Reviewing telemedicine information was added pressure, especially when clinics were already overfilled: “if you're trying to access it and the phone goes or the door goes, it's hard” (HCPAC2). To improve this, a clinic specifically for telemedicine could be started, or dedicated time could be set aside for telemedicine during the usual GDM clinics.
A historical record
As part of current care the diabetes specialist nurses provide telephone advice based on the patients' reported glucose results. Although most antenatal women were described as vigilant and comprehensive in their reporting, on occasions reporting could be “selective” (HCP AC1). Telemedicine would allow the diabetes specialist nurses to review all available glucose results, which would also be available as a permanent record.
Discussion
The World Health Organization has recommended that the introduction of telemedicine be based on patients' needs. 30 In this study the patient participants could see potential benefits from telemedicine for those with GDM, especially for busy, working women or those who live in rural areas, who would find it difficult to attend the clinic on such a frequent basis. Rural patients consistently report appreciation at not having to travel long distances. 31 Although some may prefer a face-to-face consultation, telemedicine is seen as a trade-off between seeing a specialist face-to-face and the inconvenience of traveling. 31,32
Although participants were satisfied with telemedicine, found it easy to use, and were willing to use it again, they did suggest improvements. The main priority would be for faster and more reliable transmission of data by the telemedicine hub. An important prerequisite for successful implementation of telemedicine is that the technology should be user friendly and nonintrusive. 15 Slow or unreliable transmission of data was a serious limitation to the usefulness of telemedicine, especially for those using the mobile hub and living in rural areas, where the mobile reception was poor. Given the number of households with no landline, 33,34 the proportion of patients who could be affected by this issue is not insignificant.
Healthcare practitioners often provide positive feedback in relation to telemedicine, but their approval tends to be more measured than that of patients. 31 They can perceive telemedicine as providing a greater positive impact for their patients than for their own practice. 35 This is unsurprising given the wide range of potential benefits for patients 36 and the much more limited benefits for HCPs. 31 Indeed, the HCPs in this study were unsure if they would benefit from telemedicine in terms of their workload. However, they could see the potential benefits for their patients and were willing to use telemedicine in the future for those reasons alone.
For HCPs it is important that telemedicine systems should correspond to their expectations and be reliable, ergonomic, mobile when needed, and user friendly. 37 Any technical challenges that occur during the early stages of telemedicine projects can make healthcare providers increasingly reluctant to use telemedicine again. 38 This is why adequate training is vitally important, to help to ensure that potential users have successful early experiences, encouraging them to adopt the technology. 38 The HCPs would have preferred the training to be more clinically relevant. A more detailed explanation on how to view SMBG results would have prevented HCPs from having to transcribe the information into a more familiar format, which was time consuming and negated any potential to save time through the use of telemedicine. In a survey of general practitioners and nurses in Scotland, a lack of appropriate training, cost, and increased workload were identified as the most important barriers to the use of telemedicine. 39
It is also important that telemedicine is compatible with, and integrated as smoothly as possible into, existing routine clinical and administrative practice. 23,37 This can be made difficult by the fact that the implementation of telemedicine often presents departures from standard means of healthcare delivery and administration, necessitating the development of new procedures and protocols. 40 While conducting the trial it quickly became obvious that if telemedicine was to be used in routine clinical practice, protected time would need to be set aside for HCPs to review the information and contact patients as need be.
Although they may be satisfied with telemedicine, patients have qualified their approval with the need to see a specialist in person from time to time. Likewise, HCPs have expressed the belief that modern technology should never be allowed to replace face-to-face contact. 41 –43 Instead, telemedicine should be seen as a complementary facility that adds to and strengthens, rather than replaces, face-to-face contact. 41,42 Indeed, it has been suggested, in this study and others, 17 that by saving HCPs time with some patients, telemedicine would actually allow them to spend more time with patients who need extra face-to-face contact.
Strengths and weaknesses
Rates of attrition from telemedicine interventions have been as high as 50% in the literature. 44 This was not a significant problem in this study, perhaps because of the relatively short duration of the intervention, with only one withdrawal from the telemedicine group. However, there were several individuals without a landline telephone and insufficient mobile telephone signal for successful use of telemedicine.
It has been suggested that some of the high satisfaction reported with telemedicine in rural communities could in fact be due to low satisfaction with current medical facilities. 31 An advantage of the methodology used in this study was that it was possible to rule this out. Although the questionnaires alone would have been unable to provide any insight, the interviews highlighted how happy patients were with their current level of care.
It could be argued that this sample is a self-selected group as it is unlikely that any patients with a marked aversion to technology would have agreed to take part. 45 Participants also received telemedicine in addition to their usual clinic appointments and so were being asked to make a hypothetical judgment as to the value and effect of telemedicine on their care. 46 These factors mean that the satisfaction levels reported in this study may not be readily translatable to telemedicine if it was being used in routine practice to replace alternate clinic reviews. However, participants' experiences of using the system were useful to direct its further improvement before conducting a full randomized controlled trial.
Equally, HCPs who volunteered to take part in this feasibility study may have been more positively inclined toward telemedicine than those who did not. 23 Further research with a larger number of HCPs would provide additional information about the utility of this telemedicine system and potential improvements that could be made. 12
Conclusions
The success of this feasibility study suggests that telemedicine can be used to replace alternate face-to-face review appointments in the care of those with GDM. This may help meet the growing demand on diabetes services due to increasing numbers of women being diagnosed with GDM. However, a full randomized controlled trial where telemedicine is used to provide alternate consultations is required.
Footnotes
Acknowledgments
This work constituted part of a PhD for J.E.G., which was funded by the Department for Employment and Learning for Northern Ireland. A small start-up grant was provided for the study by Derry City Council. The telemedicine service was provided free of charge at one of the trial sites. The authors would like to acknowledge Therese Gallacher, Lisa King, Eilish McIvor, and the women who took part in the study.
Author Disclosure Statement
M.J.O'K. has received research funding from Nova Biomedical (a manufacturer of glucose meters). J.E.G., B.P.B., F.D., and V.E.C. declare no competing financial interests exist.
References
Supplementary Material
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