ABDUCENS PCC AMSC 2022: SOUTH KOREA

Telemedicine Approaches on Blood Glucose Control in Women with Gestational Diabetes Mellitus: A Systematic Review from Randomized Controlled Trials Jessica Ho1a, Muhammad Azka Al atsari1, Nindya Nur Amalyah1, Christian Sipija1 1

Faculty of Medicine, Hasanuddin University, Indonesia 1a

jessicaho.352@gmail.com

ABSTRACT Introduction: Gestational diabetes mellitus (GDM) is a type of diabetes occur during pregnancy marked by hyperglycemia with the first onset during pregnancy and resolving after delivery. The traditional mode of standard care has some shortcomings, such as lagging information and insufficient communication between doctors and patients. Recently, the rapid development of information and communication technology provides new technical support and management modes for improving the clinical care of patients. In this systematic review, we performed qualitative synthesis analysis regarding the use of telemedicine tools in order to facilitate women with GDM to have better glucose control during pregnancy.

Objective: The aim of this systematic review is to evaluate the role of telemedicine in monitoring blood glucose level of patient with GDM. Method: Articles identified from PubMed, Science Direct, ProQuest, Epistemonikos, and Cochrane Library using predefined keywords, then assessed systematically according to the PRISMA flowchart diagram, resulting in 6 studies for qualitative analysis. Risk of bias was assessed using Review Manager 5.4.1.

Results: We identified 6 randomized controlled trials studies in total. There are 830 participants with GDM recruited (443 patients as intervention groups and 387 patients as control groups).

Regarding the quality of the 6 studies, three studies had good quality and three studies had moderate levels of methodological quality. This results indicate the use of telemedicine devices in order to monitor blood glucose level in patients with GDM need to be examined more in future studies due to its effectiveness for maintaining blood glucose level only shown significantly in three studies included (P<0.05).

Conclusion: The implementation of blood glucose telemonitoring can promisingly be an acceptable and effective tool for rapid blood glucose control and its maintenance especially for patient with complicated GDM and is facing difficulty to access conventional health care.

Keywords: gestational diabetes mellitus, telemedicine, blood glucose

Telemedicine Approaches on Blood Glucose Control in Women with Gestational Diabetes Mellitus: A Systematic Review from Randomized Controlled Trials

Authors: Jessica Ho Muhammad Azka Al atsari Nindya Nur Amalyah Christian Sipija

Faculty of Medicine, Hasanuddin University Asian Medical Students’ Association Universitas Hasanuddin 2022

INTRODUCTION Gestational diabetes mellitus (GDM) is a type of diabetes occur during pregnancy marked by hyperglycemia with the first onset during pregnancy and resolving after delivery. GDM occurs in one-fourth pregnancies in the world with highest prevalence in southern and eastern Asian people [1]. GDM trend in Asia has been rising these past few decades and is affecting millions of women. The danger of GDM to women and their child are unquestionable, the adverse effects towards the mother and the children are dangerous to themselves. The recurrence risk for women in their future pregnancy is up to 84%. The threat of GDM towards women and infants is a serious challenge that needs to be solved. Yet, it still faces a lot of difficulty in management. These difficulties include the access towards healthcare, glycemic control, and financial reasons [2–4].

Currently, the standard care practice for patients with GDM is that the pregnant women monitor the glycemic levels and record by hand in paper diaries several times per day at home and then healthcare professionals review the glycemic data and provide health education during the regular antenatal examination or face-to-face consultation. The traditional mode of standard care has some shortcomings, such as lagging information and insufficient communication between doctors and patients. Recently, the rapid development of information and communication technology provides new technical support and management modes for improving the clinical care of patients [5]. Moreover, in this highly sophisticated era, people tend to use internet more to do their daily activities, even the simplest ones, and the reasons are basically because internet use is very simple and highly accessible anywhere and anytime, also it costs less financial burden because it can cost less energy, time, and money to a person to do things rather than doing it offline [2–4].

Nowadays, digital solutions are available to ensure close treatment of patients with GDM. Diabetes technology includes hardware, software, and technical devices that help to control the disease. Telemedical treatments show great potential in clinical diabetes management [6]. Ideally, telemedicine facilitates the clinical management of diabetes by uploading glucose data, symptoms and signs in real-time and providing medical consultation and health education, which offers great convenience for patients in remote areas [5].

In this systematic review, we performed qualitative synthesis analysis regarding the use of telemedicine tools in order to facilitate women with GDM to have better glucose control during

pregnancy. It is necessary for women with GDM diagnosed earlier and treated with suitable management due to lowering the risks of maternal and fetal complications. This review would assess recent 5 years published articles of randomized controlled trials study that use telemedicine as an intervention for women with GDM, we hope that it would be more reliable related to the current situation. Prior reviews have proposed that telemedicine is an effective approach for GDM during the pandemic, but further studies are required to assess the intervention effects in relation to another blood glucose parameter being examined [6].

MATERIALS AND METHODS This systematic review is based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and organized adhering to previously recommended guidelines for transparent and comprehensive reporting of methodology and result.

Data Source and Search Strategy Four reviewers (J.H., M.A., N.N., C.S.) search this review using online search engineering with five database including PubMed, Science Direct, ProQuest, Epistemonikos, and Cochrane Library. The keywords used during the search were “gestational diabetes mellitus” OR “GDM” AND “telemedicine” OR “telemonitoring” OR “remote monitoring” AND “blood glucose”.

Eligibility Criteria Eligible studies are randomized controlled trials (RCTs) that include patients with gestational diabetes mellitus, which used telemedicine to control patient’s blood glucose level as the intervention, and change in blood glucose level between intervention group and control group for evaluation. The control group receive either usual care or enhanced standard care for blood glucose control. Only English and Indonesian literatures, as well as last 5-years studies were reviewed for this study.

Study Selection Studies are identified using keywords used during the search. After removing duplicates using Rayyan.ai program, four independent reviewers (J.H., M.A., N.N., C.S.) screened retrieved studies based on their title and abstracts. Studies without women with GDM as their population,

telemedicine as their method of intervention, and change in blood glucose level as their parameter of outcome were excluded. Thereafter, potentially eligible full-text studies were thoroughly assessed using the eligibility criteria described above. Any emerging discrepancies will be resolved by consensus among the review team.

Quality Assessment To evaluate the risk of bias in selection, performance, detection, attrition, and outcome reporting, this study utilizes Review Manager 5.4.1. Results are then classified into high risk, low risk, or unclear risk for risk of bias. Four authors (J.H., M.A., N.N., C.S.) evaluate the risk of bias independently and discuss together to form a summary.

Data Extraction Data from each study is collected and then inputted into a table. The following data are extracted from the included studies: 1) first author and publication year; 2) study design; 3) number of participants; 4) type of intervention; 5) intervention and control details; 6) outcomes; and 7) Pvalue.

RESULTS AND DISCUSSION A preliminary search in five electronic database (PubMed, Science Direct, ProQuest, Epistemonikos, and Cochrane Library) yielded 507 articles and 71 duplicate articles were removed. Then, authors read the title and abstracts of remaining 436 articles for preliminary screening, resulted in 11 eligible articles for further analysis. However, author could not retrieve 2 articles due to unavailable full-text resulted in only 9 reports assessed for eligibility. Finally, author excluded 3 articles for neither using RCTs as study design nor having complete outcome data. A total of 6 studies were included in the systematic review at last [7–12]. Search flowchart and selection methods in this systematic review was summarized in Figure 1.

Figure 1. PRISMA flow chart of study selection

Characteristics of Included Studies Outcome data were available from 6 studies using randomized controlled trials (RCTs) with telemedicine as their method of intervention, standard clinic care as comparison, and change in blood glucose level between two groups as their outcome parameter. Subject included in those studies are pregnant women diagnosed with GDM. Total of participants included in those studies were 830 participants (443 participants as intervention group and 387 participants as control group). Three studies showed significant difference in blood glucose level change between telemedicine intervention compared to standard care statistically using P-value data [7,8,12], two study didn’t show significant difference statistically [10,11], while one study didn’t report P-value data in their result [9]. Full details of each study are displayed in Table 1.

Risk of Bias Assessment All of the studies clearly described the method used to generate random allocation sequence and allocation concealment. None of the studies clearly described if they did blinding of participants and personnel. Less than 25% of the studies did blinding of outcome assessment. None of the studies deal with the incomplete outcome data, as well as had reporting bias. As a summary, three studies had good quality [8,10,11] and three studies had moderate level of methodological quality [7,9,12]. The results from Review Manager 5.4.1 for risk of bias assessment were displayed in Figure 2A and Figure 2B. This results indicate that the use of telemedicine device in order to monitor blood glucose level in patients with GDM need to be examined more in future studies due to its effectiveness for maintaining blood glucose level only show significant in three studies included (P<0.05) [7,8,12].

Although the other results are insignificant, the studies still can be used just like the conventional ones. So women with GDM can have preferable choice to choose whether they want to use usual care or telemedicine instead.

2.

1.

No.

[8]

al., 2018

H. Guo et

[7]

al., 2018

Al-ofi et

year

Author,

Type of

RCT

RCT

CG (60)

IG (64)

CG (30)

IG (27)

App-based

App-based

design participants intervention

Study Number of

treatment

Control: standard outpatient

gestational diabetes mellitus

educational information about

transmission and feedback, and

Usual care + mHealth app for data

Control group: traditional monitoring

weeks post-delivery

gestation) and continued until 6

with GDM (24–28 weeks of

gain start from the day of diagnosis

to monitor blood sugar and weight

a telemonitoring device which used

Intervention group was supplied with

Intervention and control details

Outcomes

0.74 IG: 4.9 (0.9) CG: 5.0 (0.8)

FBG:

0.001

HbA1c:

0.002

PPG:

P-value

FBG (change) (mg/dL)

CG: 5.3 (0.3)

IG: 4.7 (0.2)

HbA1c (change) (%)

mmol/L)

Mean 2-hour PPG (6.9±0.6

mmol/L)

Mean FPG CG (6.5±0.8

Table 1. Characteristics of included studies in the systematic review

5.

2020 [11]

Rollo et al.,

[10]

4. et al., 2018

Rasekaba

[9]

3. et al., 2018

Mackillop

RCT

RCT

RCT

CG (14)

IG2 (13)

IG1 (15)

CG (34)

IG (61)

CG (102)

IG (101)

App-based

Web-based

phone-based

Mobile

SMBG : ≤ 5.00 mmol/L

dietary information, and symptoms

treatment

Control: standard outpatient

CG: 5,19 (0,09)

IG2: 5,14 (0,04)

IG1: 5,12 (0,02)

(%)

Balance Beyond” website combined with telehealth video coaching

HbA1c (change in 3 months)

≤ 6.7 mmol/L

Intervention group used the “Body

Control: usual care

controlled health record

2-hours post-prandial SMBG :

group

glucose (SMBG), insulin dosing,

on a proprietary web-based patient

In intervention and control

CG: 0.03% rise per 28 days

IG: 0.02% per 28 days

HbA1c (change) (mg/dL)

CG: -0.14 mmol/L/28 days

IG: -0.16 mmol/L/28 days

(mmol/L)

Blood Glucose (change)

include self-monitoring blood

Intervention group enter their data

Control: standard clinic care

glucose readings

record, tag, and review blood

GDM-health app and taught how to

mobile phone with the preinstalled

Intervention group were loaned a

0.673

HbA1c:

P>0.05

reported

Not

6.

2021 [12]

Tian et al.,

RCT

CG (147)

IG (162) App-based

Group 3 IG: 80.00 (50.00, 100)

Control: standard outpatient treatment

CG: 52.78 (40.00, 87.50)

IG: 50.00 (26.67, 75.00)

Group 4

CG: 62.50 (50.00, 90.00)

CG: 62.50 (50.00, 75.00)

IG: 80.00 (62.50, 87.50)

Group 2

CG: 54.79 (46.67, 80.00)

care group

group or a routine clinical prenatal

group chat-based BG management

Intervention group used a WeChat

IG: 83.33 (62.50, 100)

Group 1

(%)

Glycemic Qualification Rate

CG: 5,21 (0,11)

IG2: 5,12 (0,02)

IG1: 5,16 (0,06)

(%)

HbA1c (change in 6 months)

P<0.05

A

B

Figure 2. Quality assessment of RCTs. (A) Risk of bias graph: review of authors’ judgements regarding the risk of bias item presented as percentage for all included studies. (B) Risk of bias summary: review of authors’ judgements regarding the risk of bias for each included study.

Technology and Technical Features In the intervention groups, participants were provided with one or more of the telemedicine devices or apps (a Smartphone-Glucometer, GDm-Health app, web program, social media app such as WeChat, etc.) and given full instructions and training on how to using the system. The intervention started variously from the day of diagnosis with GDM (24 – 28 weeks of gestation) and some of the studies continued until delivery. The devices or apps were used to monitor pregnant women parameters, including blood sugar for GDM women. Participants were asked to do the measurement of blood sugar and submitted the routine results to the apps. Data stored was reviewed by the diabetic care team at the clinic to evaluate the participants' needs in terms of further interventions, such as medication adjustments. Interestingly, one of the studies designed an auto reminder if the participant predefined thresholds and not recording number of blood glucose readings per week or more glucose testing strips were planned [9]. Moreover, participants who use apps, could also assist in self-management according to their real time condition and share photos of their meals and snacks, exercise, and experience regarding blood glucose control [12].

Participants in the control group received usual or standard care only. They measure their blood glucose values in a paper diary. Every visit time, for 2 or 4 weeks they attended the outpatient clinic for control. Unlike the intervention group, women with GDM were supposed to contact their physician if their blood glucose breached predefined thresholds just by themselves. The routine prenatal care took place at the clinic, doctors manually checked the details of participants’ lifestyle diaries, including daily diet, exercise, weight, and blood glucose based on their records. If participants failed to present their diaries, doctors asked them to return weeks after. If the blood glucose target cannot be controlled after non-pharmacologic or lifestyle therapy, drug-based interventions were considered after multidisciplinary consultation.

Telemedicine as Choice in Gestational Diabetes Mellitus Management Telemedicine approaches are an alternative choice besides conventional or standard GDM therapies. It is inevitable that telemedicine is growing because of its beneficiaries as well as cost and time effectiveness [6]. Generally, telemedical approaches offer promising outcomes for GDM management. Our review showed that telemedical therapy can improve glycemic control, reduce the rate of blood glucose, and increase patient’s adherence to self-measurements of blood glucose [7–12]. Regardless of different modality of telemedical interventions, we were able to conduct that

sort of modalities such app-based, web-based, mobile phone-based enable a more frequent and personalized management.

Physical Therapist-Patient Relationship Telemedicine for GDM in pregnant woman is a major invention to ease their accessibility to healthcare. Most studies show major satisfaction from the participants towards the provided telehealth consultation system. The telehealth system helps women with different background in accessing the healthcare. the major issues that women encounter in consultation are social anxiety, limited access towards the healthcare system, and also other socioeconomic and medical reasons.

Telemedicine also helps facilitating women with special care needs that requires more time with their physician that can be mutually beneficial towards the physician and the women themselves, because it can save more time and money for consultation. The studies also indicate that the participants have a good relationship with the physician because most participants feel more open and comfortable in consulting their conditions and test results without feeling anxious or uncomfortable [7–12].

Advantages and Challenges of Telemedicine Telemedicine has advantages due to its benefits and also several challenges for future development and usage. Benefits of telemedicine are helps to connect physicians to rural areas, ease both physicians and patients for making appointments, and can save costs for patients with low financial background. Besides its advantages explained above, telemedicine has several limitations that are challenging for its usage. First, telemedicine care sometimes does not provide a secure way to protect patient’s data that makes it vulnerable for patient safety. Telemedicine can also make it difficult to use due to limited knowledge about telemedicine devices from the patients.

Telemedicine care cannot replace all conventional care because some conventional care is still needed for diagnosis and disease monitoring, that cannot be performed by telemedicine care, such as physical and laboratory examination. Several other limiting factors of telemedicine are insufficient doctor-patient communication that is necessary for understanding the patient’s conditions and inadequacy of the legal supervision [13].

Limitations

Our systematic review only consists of few randomized controlled trials. There are different blood glucose measurements used in included studies (HbA1C, FBG, or PPG). Those measurements make different threshold values for the diagnosis of GDM that affect the findings and must be considered. With different definitions of GDM, participants may not be precisely comparable. A uniform global definition of GDM would be necessary to address this issue.

CONCLUSION AND RECOMMENDATION Observing the upward trend of GDM in Asia these past few decades and its difficulty in management, telemedicine considered as a promising solution for GDM management. As a conclusion, we found that across 6 randomized controlled trials with total of 830 participants, 3 of them stated that the implementation of blood glucose telemonitoring significantly reduced the blood sugar level within certain date of follow-up compare with common modality, based on the reduction of blood glucose data and statistical analysis. It can promisingly be an acceptable and effective tool for rapid blood glucose control and its maintenance especially for patient with complicated GDM and is facing difficulty to access conventional health care. The results of this systematic review is expected to be a consideration for further studies and the development of telemedicine in managing GDM, especially in Asia where the prevalence of GDM is still considered as a serious threat that needs to be solved.

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