Accepted Manuscript

The impact of a daily smartphone-based feedback system among women with

gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy
outcome: a randomized controlled trial

Hadas Miremberg, MD, Tal Ben-Ari, MD, Tal Betzer, MD, Hagit Raphaeli, MD, Rose
Gasnier, MD, Giulia Barda, MD, Jacob Bar, MD, Msc, Eran Weiner, MD
PII: S0002-9378(18)30133-9
DOI: 10.1016/j.ajog.2018.01.044
Reference: YMOB 12070

To appear in: American Journal of Obstetrics and Gynecology

Received Date: 12 November 2017

Revised Date: 30 January 2018
Accepted Date: 31 January 2018

Please cite this article as: Miremberg H, Ben-Ari T, Betzer T, Raphaeli H, Gasnier R, Barda G, Bar J,
Weiner E, The impact of a daily smartphone-based feedback system among women with gestational
diabetes on compliance, glycemic control, satisfaction, and pregnancy outcome: a randomized
controlled trial, American Journal of Obstetrics and Gynecology (2018), doi: 10.1016/j.ajog.2018.01.044.

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 ACCEPTED MANUSCRIPT
The impact of a daily smartphone-based feedback system among women with

gestational diabetes on compliance, glycemic control, satisfaction, and pregnancy

outcome: a randomized controlled trial

Hadas MIREMBERG, MD¹,², Tal BEN-ARI, MD¹,²,³, Tal BETZER, MD¹,², Hagit

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RAPHAELI, MD¹,², Rose GASNIER, MD¹,², Giulia BARDA, MD¹,², Jacob BAR,

MD, Msc¹,², Eran WEINER, MD¹,²

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¹Departments of Obstetrics & Gynecology, The Edith Wolfson Medical Center,

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Holon, Israel, ²Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel,

³Pediatric Endocrinology and Diabetes unit, The Edith Wolfson Medical Center,

Holon, Israel.
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Disclosure statement: the authors report no conflict of interest.
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Funding: this study was not funded.

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Clinical trial identification number: NCT02783612 clinical-trials.gov

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Paper presentation information: This study will be presented in oral format at

the Society for Maternal-Fetal Medicine's 38th Annual Meeting on January 29 -

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February 3, 2018 in Dallas, TX.

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Corresponding author:
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Hadas Miremberg, MD

Departments of Obstetrics & Gynecology

The Edith Wolfson Medical Center

P.O Box 5, Holon 58100 Israel

Phone: 972-3-5028329; Fax: 972-3-5028503

Email address: dasile2@gmail.com

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Condensation: Smartphone-based daily feedback between GDM patients and

physicians improved patient compliance, glycemic control, and lowered the rate of

insulin treatment.

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Short version of title: RCT on the impact of smartphone-based daily feedback among

women with GDM on patient compliance.

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Implications and Contributions:

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A. To resolve uncertainty as to whether smartphone-based daily feedback is effective

in improving GDM patient compliance and glycemic control.

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B. Smartphone-based daily feedback between GDM patients and physicians improved
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patient compliance, glycemic control, and lowered the rate of insulin treatment.

C. What this study adds to our knowledge: This study adds information about the use
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of smartphone- based feedback between GDM patients and their physicians on

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improving patient compliance, glycemic control and lowering the rate of insulin
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treatment.
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ABSTRACT

Background – Patient compliance and tight glycemic control have been demonstrated

to improve pregnancy outcome in pregnancies complicated by gestational diabetes

mellitus (GDM). The use of advanced technological tools, including smartphone-

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based platforms, to improve medical care and outcomes has been demonstrated in

various fields of medicine, but only few small studies were performed with GDM

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patients.

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Objective- We aimed to study the impact of introducing a smartphone-based daily

feedback and communication platform between GDM patients and their physicians,

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on patient compliance, glycemic control, pregnancy outcome, and patient satisfaction.
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Study design- This is a prospective, single-center, randomized controlled trial. Newly
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diagnosed GDM patients presenting to our multidisciplinary diabetes-in-pregnancy

clinic were randomized to: (1) routine bi-weekly prenatal clinic care (control group)
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or (2) an additional daily detailed feedback on their compliance and glycemic control
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from the clinic team via an application installed on their smartphone (smartphone

group). The primary outcome was patient compliance defined as the actual blood
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glucose measurements/instructed measurements X100. The secondary outcomes

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included diabetes-control parameters, pregnancy, and neonatal outcomes. The study

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was adequately powered to detect a 20% difference in patient compliance, based on a

preliminary phase that demonstrated 70% baseline compliance to glucose

measurements.

Results – A total of 120 newly diagnosed GDM patients were analyzed. The two

groups did not differ in terms of age, parity, education, body mass index (BMI),

family history, maternal comorbidities, oral glucose tolerance test (OGTT) values,
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and hemoglobin A1C (HbA1C) at randomization. The smartphone group

demonstrated higher level of compliance (84 ± 0.16% vs. 66 ± 0.28%, p<0.001),

lower mean blood glucose (105.1 ± 8.6 mg/dL vs. 112.6 ± 7.4 mg/dL, p<0.001), lower

rates of off-target measurements both fasting (4.7 ± 0.4 % vs. 8.4 ± 0.6%, p<0.001)

and 1 hour post-prandial (7.7 ± 0.8% vs. 14.3 ± 0.8%, p<0.001), and a lower rate of

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pregnancies requiring insulin treatment (13.3% vs. 30.0%, p=0.044). The rates of

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macrosomia, neonatal hypoglycemia, shoulder dystocia and other delivery and

neonatal complications did not differ between the groups. Patients in the smartphone

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group reported excellent satisfaction from the use of the application and from their

overall prenatal care.

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Conclusion- Introduction of a smartphone-based daily feedback and communication

platform between GDM patients and the multidisciplinary diabetes-in-pregnancy

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clinic team, improved patient compliance, glycemic control, and lowered the rate of

insulin treatment.
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INTRODUCTION

Gestational diabetes (GDM) prevalence is estimated to complicate 8-9% of all

pregnancies,1,2 and is rising due to an increased rate of obesity and sedentary

lifestyle.3,4 Patients with GDM have a higher risk for developing preeclampsia,5

shoulder dystocia, birth injury and cesarean delivery.6 GDM is also associated with an

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increased risk for early and late neonatal complications.7,8

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Tight glycemic control in GDM patients has been shown in numerous trials to reduce

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maternal, fetal, and neonatal complications.9,10 The management of patients with

GDM poses a unique challenge, mainly due to the limited time available for potential

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interventions, between the time of the diagnosis and delivery. Furthermore, the
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management is primarily based of self-performed blood glucose (BG) monitoring and

reporting,11,12 and clinical decisions, such as the initiation of pharmaceutical therapy

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and timing of delivery, are based on these measurements.

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Patient compliance to BG monitoring, as well as tight glycemic control have been

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demonstrated to play a pivotal role in determining pregnancy outcome.10,13,14

Telemedicine and advanced technology were shown to improve glycemic control in

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the non-pregnant diabetic population.15,16 However, only small scaled studies

concerning the incorporation of advanced technological platforms for GDM patients

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were published.17,18 Moreover, the evidence regarding the use of smartphone

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technology, compared to standard care, is scarce.19 Therefore, in light of the

"smartphone revolution" of recent years, we aimed to fill this gap by studying the

effect of a daily smartphone-based feedback system in the care of GDM patients on

patient's compliance, glycemic control and pregnancy outcome.

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MATERIALS AND METHODS

Population

A randomized controlled trial conducted over a period of 12 months (May 2016-May

2017) at a single, tertiary, university-affiliated medical center. The study was

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approved by the local institutional review board (IRB number 0037-16-WOMC dated

02/2016) and was registered with the clinical trials registry (clinical-trials.gov

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identifier NCT02783612).

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Eligibility was limited to women aged 18-45 years, singleton gestations, with no pre-

gestational diabetes (per history and per first trimester fasting glucose assessment),

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and first diabetes-in-pregnancy clinic visit prior to 34 gestational weeks. As per the
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design of the study, all patients were also required to speak English, at least to a level

that enabled them to use the app and communicate with the clinic team.
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According to our departmental protocol, GDM is diagnosed using the two-step

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process.12 The first step is screening at 24-28 weeks of gestation using 50-grams, 1-
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hour glucose challenge test (GCT). Women whose glucose levels exceed 140 mg/dL

undergo a 100-g, 3-hour oral glucose tolerance test (OGTT). GDM is diagnosed in
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women who have two or more abnormal values on the 3-hour OGTT (fasting ≥ 95

mg/dL, 1-hour ≥ 180 mg/dL, 2-hours ≥ 155 mg/dL, 3-hours ≥ 140 mg/dL).20
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Additionally, women with one abnormal value in the OGTT and an additional risk

factor (obesity, GDM in a previous pregnancy, or a first-degree family member with

diabetes mellitus type 2) are also diagnosed with GDM, as it was previously shown

that these patients are also at a significantly higher risk of adverse perinatal

outcome21.

Study design and group assignment

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Patients diagnosed with GDM who own a smartphone were approached for

recruitment during their first visit in our prenatal multidisciplinary diabetes-in-

pregnancy clinic.

Our clinic accepts patients screened for GDM in "low risk" community centers by

their primary obstetricians. According to our local guidelines, GDM patients are

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referred to a "high risk" clinic upon diagnosis for the remaining prenatal care.

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Therefore, all patients recruited to this study were recruited upon GDM diagnosis

and had no prior intervention.

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After obtaining a written informed consent, patients were randomly assigned either to

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the intervention group (smartphone group) or to the control group in a 1:1 ratio. A
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blocked randomization scheme was created using a computer-generated list of random

numbers.
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The routine prenatal care provided by our diabetes-in-pregnancy clinic is comprised

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of a first visit, subsequent bi-weekly visits up to 35 weeks of gestation, and weekly

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visits from 35 weeks of gestation until delivery. The maternal-fetal medicine

specialist, according to each patient's individual data, can modify the appointment
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frequency, according to the individual patients' glycemic control. During the first

visit, the patient receives consultation from a maternal-fetal medicine specialist,

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education regarding the proper use of the glucometer by a trained nurse, and dietary
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counseling by a certified dietician, regarding the principles of proper nutrition in

GDM and the planning of a weekly menu. In addition, patients receive counseling

regarding recommended physical activity (moderate-intensity exercise three times a

22–24
week for 20-45 minutes each time). Subsequent bi-weekly visits include blood

pressure monitoring, urine dipstick for proteinuria, reviewing of the BG

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measurements and decision-making regarding the need for additional therapies, 20-

minutes non-stress test (NST), and a sonogram for fetal weight, amniotic fluid

volume, and biophysical profile. Patients non-compliant to physical activity

recommendation are counseled again. Patients are instructed to monitor BG four times

a day (once at morning fasting and after each primary meal), and manually record the

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measurements on a paper diary for review with their physician at each visit.

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Patients allocated to the control group received the aforementioned care. Patients

assigned to the smartphone group received our standard care, and in addition had an

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application installed to their smartphones. The application is web-based, freely

available, and simple to use (https://www.glucosebuddy.com) and was available

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during the study period for both iOS and Android users. All patients received a 10-
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minute demonstration regarding the use of the application from one of our research
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coordinators, in addition to a detailed information brochure.

Each patient documented each of her BG measurements using the application, which
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generated a daily report transmitted by email every evening to our computerized

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research database. Every evening (including weekends), the patient received via email

an individualized feedback from our clinic team regarding her daily glycemic control.
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This feedback could include reassurance and positive feedback, dietary tips in attempt
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to optimize specific off-target measurements, modifications in insulin treatment, or

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alerts to re-schedule an earlier appointment to the clinic. In addition, patients were

encouraged to use the platform to ask questions and receive immediate answers

regarding any aspect of GDM management. As per the study protocol, medical

treatment could only be initiated in a formal clinic appointment and not via the

application.
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As a rule of thumb, it is the policy of our clinic to initiate medical therapy when BG

levels exceeded 95 mg/dl (fasting) or 140 mg/dl (1-hour post-prandial) in more than

30% of the measurements. The decision is individualized by the clinic team

(maternal-fetal medicine specialist and endocrinologist) for each patient. In general,

we prescribe long acting insulin (Insulin Detemir), and if needed short acting insulin

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(Insulin Aspart). None of the patients in the current study received oral anti-glycemic

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medications.

Physicians in our clinic, providing care to the patients on their regular appointments,

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were not blinded to the group allocation. However, all staff in our labor and delivery

ward and the neonatology division were blinded to group allocation.

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Data collection
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Upon recruitment, the following demographic data were collected: maternal age,

parity, previous obstetric history, family history of DM, chronic hypertension,25

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thrombophilia, smoking status, previous GDM, assisted reproductive technology,

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fasting glucose obtained at first trimester, values of GCT and OGTT, first trimester

fasting glucose, hemoglobin A1C (HbA1C) upon diagnosis, educational status, and
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level of physical activity. Each patient's height, weight, and body mass index (BMI)
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were recorded.
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Obstetrical data collected included gestational age at delivery, mode of onset of labor,

the presence of preeclampsia or gestational hypertension,25 polyhydramnios (amniotic

fluid index > 95th percentile for gestational age),26 antenatal corticosteroids

administration,27 mode of delivery, shoulder dystocia, the use of episiotomy, or third/

fourth degree perineal tears.

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Immediately after birth, a pediatrician examined all neonates. Birth weight percentiles

for gestational age were assigned using the updated local growth charts.28 Large for

gestational age (LGA) was defined as an actual birth weight ≥ 90th percentile for

gestational age. We collected data regarding birth weight, birth weight percentile, rate

of LGA, neonatal length of stay, neonatal intensive care unit (NICU) admission,

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hypoglycemia of the newborn (BG < 40 mg/dL), respiratory morbidity (respiratory

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distress syndrome, transient tachypnea of the newborn, mechanical ventilation, or

need for respiratory support), phototherapy, and neonatal death.

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Women in the smartphone group were approached during the last prenatal visit,

and were asked to fill a short questionnaire (in Hebrew) regarding their satisfaction

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with their prenatal care, the use of the app, and regarding difficulties with the app
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use.
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Outcomes
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The primary outcome was patient compliance, expressed as percentage, and defined
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as the actual blood glucose measurements/instructed measurements X100. The

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measurements were recorded from each patient BG diary in the control group, and

from our research application-based data system in the smartphone group.

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Secondary outcomes included: 1) Diabetes-control parameters: mean blood glucose

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(mean ± SD of all measured values), need for insulin treatment, and percentage of off-

target measurements (thresholds: fasting>95 mg/dL and 1-hour post-prandial>140

mg/dL); 2) Pregnancy outcomes: polyhydramnios, preeclampsia, gestational

hypertension, need for induction of labor, instrumental or cesarean delivery, shoulder

dystocia, third or fourth degree perineal tears; and 3) Neonatal outcomes: neonatal
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weight, LGA, NICU admission, hypoglycemia of the newborn, respiratory morbidity,

phototherapy, neonatal death, and composite adverse neonatal outcome.

Composite adverse neonatal outcome was defined as the presence of one or more of

the following early neonatal complications: hypoglycemia of the newborn, respiratory

morbidity, phototherapy, or neonatal death.

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Sample size calculation

A total of 120 participants, 60 participants per group were needed to be recruited to

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detect a 20% difference in compliance (from a baseline of 70% to 90%) between the

smartphone and control group, with an α=0.05 and β=0.20. This calculation was based

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on preliminary retrospective data from our clinic (from the 6 months prior to the
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study) that the baseline expected compliance in the control group is 70%.
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Statistical analysis
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Categorical variables were compared between the groups using chi square test or
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Fisher exact test and continuous variables were compared between groups using

Student's t test. P < .05 was considered statistically significant. Data were analyzed by
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SPSS statistical analysis software v23.0 (IBM Inc., USA).

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RESULTS

A total of 126 patients were randomized, 65 were assigned to the control group (of

which 5 were lost to follow up) and 61 were assigned to the intervention group (of

which 1 patient was lost to follow up). The final analysis included 120 participants, 60

in each group (Figure 1). The six patients lost to follow up were allocated (due to

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patient convenience reasons) to a different clinic after randomization, and therefore

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were not included in the analysis.

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Maternal demographic characteristics are shown in Table 1. There were no significant

differences between the groups. Six of the patients in the smartphone group and eight

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of the patients in the control group were included based on one pathological OGTT
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value.

The glycemic control characteristics are shown in Table 2. The primary outcome,
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which was pre-specified as patient compliance, was higher in the smartphone group as
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compared to the control group (84 ± 0.16% vs. 66 ± 0.28%, p<0.001). Mean blood
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glucose was significantly lower in the smartphone group as compared to the control

group (105.1 ± 8.6 mg/dL vs. 112.6 ± 7.4 mg/dL, p<0.001). The overall rate of insulin
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treatment was lower in the smartphone group compared to the control group (13.3%

vs. 30.0%, p=0.044), as well as the rates of off-target measurements both fasting (4.7
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± 0.4 % vs. 8.4 ± 0.6 %, p<0.001) and 1 hour post-prandial (7.7 ± 0.8% vs. 14.3 ±
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0.8%, p<0.001).

Pregnancy and delivery characteristics are summarized in Table 3. There were no

differences between the groups in any of the measured characteristics.

Table 4 presents the neonatal outcome parameters of the two groups. We found no

differences between the groups in any of the outcomes.

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All 60 patients in the smartphone group reported "high" or "very high" satisfaction

with their application-based prenatal care, and 80% of the patients reported no

difficulty using the application (20% of the patients reported slight difficulty mainly

related to English language barrier).

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COMMENT

In the current study, GDM patients randomized to use smartphone as part of their

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GDM management demonstrated a higher level of compliance to BG monitoring,

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lower mean blood glucose values, and a lower rate of off-target measurements, both

fasting and 1 hour post-prandial. In addition, patients in the smartphone group also

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demonstrated a lower rate of the need for insulin treatment. Patients in the smartphone
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group reported a high level of satisfaction from their care, and felt that the use of this

intervention was convenient and acceptable.

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It is well established in the literature that the treatment of GDM by a multidisciplinary

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approach combining diet modifications and medical treatment improves pregnancy

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outcome.10 Pregnancy outcome is closely associated with each patient's glycemic

control. 29,30 Currently, the main principle of decision-making in managing GDM

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patient is each patient's reported glycemic control, which depends on the patient's

compliance with self-performed capillary BG monitoring.

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Current estimations report that more than 80 percent of the population in developed

countries (up to 95 percent in some countries) own a cellular phone, most of which

are "smartphones" with internet availability. These numbers are probably higher in the

reproductive-aged population. In recent years attempts are made to translate this

"smartphone revolution" to improve medical care in all fields of medicine,31,32 and

specifically in the diabetic population.16

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GDM patients could potentially benefit from advanced technology platforms to

improve their compliance and thereafter pregnancy outcome. Ming et al.19 in a

systemic review and meta-analysis, concluded that there is insufficient evidence that

smartphone technology is superior to standard care for women with GDM. However,

the seven trials included in the meta-analysis were all small and underpowered.

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Despite proven feasible, 18,33,34 currently, the literature lacks randomized controlled

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trials comparing a smartphone-based daily communication platform between GDM

patients and their care-takers to standard care. In addition, none of the previous

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published papers attempted to investigate such an effect on detailed pregnancy

outcomes.

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This current study demonstrated that smartphone-based technology could indeed

improve not only the adherence to self-performed BG monitoring but also glycemic
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control parameters such as mean blood glucose, off-target measurements, and the

need for insulin treatment. Advanced technology provided us the platform to perform
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this study and maintain a daily communication and feedback system with our patients.
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We attribute our encouraging results to the individualized approach of our study. We

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were able to quickly respond, address patient concerns, reassure, warn, or modify

individual patient's treatment plan- on a daily basis, compared to our bi-weekly

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standard protocol.
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Our study has several strengths. First, it was the first randomized controlled trial to

compare GDM patient compliance, glycemic control, and pregnancy outcome

between a smartphone-based daily communication platform and standard care.

Second, the current study was adequately powered to detect differences in the primary

outcome. Third, it was performed in a single center multidisciplinary diabetes-in-

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pregnancy clinic, similar to those that exist in most academic centers – emphasizing

the generalizability of the results.

The current study is not without limitations. First, despite being powered to address

the primary outcome, it was underpowered to address the secondary outcomes, which

are of major clinical significance. We did observe some promising trends such as

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lower birth weights, a lower rate of CD, and a lower rate of composite adverse

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neonatal outcome in the smartphone group, however the study was underpowered for

these differences to reach statistical significance. Second, the nature of the study did

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not allow blinding the physician meeting the patient in the clinic routine visits to the

group allocation. Third, our study included only patients who own a smartphone,

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speak English, and are compliant to seek medical care in a tertiary center
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multidisciplinary diabetes-in-pregnancy clinic. These inclusion criteria probably
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under-represent a high-risk low socioeconomic population that does not meet these

criteria.
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In conclusion, we believe that the current study sheds new light on an important
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concept: advanced smartphone based technology can be used for daily patient-

physician communication and feedback and subsequently potentially improve the

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medical outcome. Indeed, GDM patients in this study demonstrated better

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compliance, improved glycemic control parameters, required less insulin treatment,

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and reported a very high satisfaction rate with the process. Our future research will

focus on performing larger randomized controlled trials powered to study the effect of

this platform on specific pregnancy outcomes. Indeed, we plan to begin soon

recruitment of patients to a second study in which the primary outcome will be

delivery of neonates Large for Gestational Age. We will recruit 378 women (189 in
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each group) to identify a 50% decrease in LGA over a period of two years. We will

publish our results, as they will be available.

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ACKNOWLEDGMENTS

The authors wish to thank the entire staff of the multidisciplinary diabetes-in-

pregnancy clinic at the Edith Wolfson Medical Center, Holon, Israel, headed by Mrs.

Essaev Stella, RN (nursing team leader), for their dedicated contribution that made

this study possible.

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Table 1: Maternal characteristics of the study groups

Smartphone group Control group

p-value
n=60 n=60
Maternal age (years) 31.7±4.2 32±6.3 0.973

Nulliparity, n (%) 29 (48.3) 19 (31.6) 0.093

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BMI (kg/m2) 27.1±5.1 27.1±5.2 >0.99

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Chronic hypertension, n (%) 5 (8.3) 1 (1.7) 0.207

Thrombophilia, n (%) 1 (1.7) 0 >0.99

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Smoking, n (%) 3 (5) 7 (11.7) 0.322

ART, n (%) 3 (5) 7 (11.7) 0.322

Previous CD, n (%)

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Previous GDM, n (%) 12 (20) 18 (30) 0.291
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Family history of DM, n (%) 30 (50) 20 (33.3) 0.095

First trimester fasting glucose (mg/dl) 88.8±6.8 87.6±8.5 0.913

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GCT value (mg/dl) 173.1±23 169.4±28.8 0.919

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OGTT – fasting value (mg/dl) 90.7±9.2 94.3±12.1 0.813

OGTT- 60 minute value (mg/dl) 202.3±23.3 197.5±22.9 0.883

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OGTT -120 minute value (mg/dl) 168.3±34.8 163.6±33.2 0.922

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OGTT- 180 minute value (mg/dl) 110.4±38.4 107.5±33.5 0.954

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One abnormal OGTT value, n (%) 6 (10.0) 8 (13.3) 0.777

Hemoglobin A1C at randomization 5.2±0.33 5.2±0.4 >0.99

Primary language Hebrew, n (%) 59 (98.3) 59 (98.3) >0.99

College/university degree, n (%) 21 (38.2) 18 (37.5) >0.99

School years 13.6±1.8 13.6±2 >0.99

Physical exercise, n (%) 5 (8.3) 7 (11.7) 0.762

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All data are shown as number (%) or mean ± standard deviation. BMI- body mass index; ART- assisted
reproductive technology; ; CD- cesarean delivery; GDM- gestational diabetes mellitus; DM- diabetes
mellitus; GCT- glucose challenge test; OGTT- oral glucose tolerance test

Table 2: Glycemic control characteristics of the study groups

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p-value
Smartphone group Control group
n=60 n=60

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Compliance (%) 84±0.16 66±0.28 <0.001

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Mean blood glucose (mg/dl) 105.1±8.6 112.6±7.4 <0.001

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Percentage of off-target 1 hour 7.7 ± 0.8 14.3 ± 0.8 <0.001
post prandial glucose
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measurement
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Percentage of off-target fasting 4.7 ± 0.4 8.4 ± 0.6 <0.001

glucose measurement
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Insulin treatment n (%) 8 (13.3) 18 (30) 0.044

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All data are shown as number (%) or mean ± standard deviation. Values in bold are statistically
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significant. Compliance- actual blood glucose measurements/instructed measurements X100.

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Table 3: Pregnancy and delivery characteristics of the study groups

Smartphone group Control group p-value

n=60 n=60

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Antenatal corticosteroids, n (%) 7 (11.7) 3 (5) 0.322
Gestational hypertension, n (%) 0 1 (1.7) >0.99

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Preeclampsia, n (%) 3 (5) 2 (3.3) >0.99
Polyhydramnios, n (%) 0 4 (6.7) 0.118

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Gestational age at delivery (weeks) 38.2±1.7 38.5±1.4 0.892
Induction of labor, n (%) 24 (40) 17 (28.8) 0.248

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Normal vaginal delivery, n (%) 48 (80) 40 (67.7) 0.147
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Instrumental delivery, n (%) 4 (6.7) 1 (1.7) 0.364
Episiotomy, n (%) 9 (15) 6 (10.2) 0.582
3rd/4th degree perineal tear, n (%) 0 0 >0.99
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Shoulder dystocia, n (%) 0 0 >0.99

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Cesarean delivery, n (%) 12 (20) 20 (33.3) 0.147

Emergent cesarean delivery, n (%) 4 (6.7) 7 (11.6) 0.528
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All data are shown as number (%) or mean ± standard deviation. Antenatal corticosteroid treatment
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administrated between 24-34 weeks of gestation.

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Table 4: Neonatal outcomes in the study groups

Smartphone group Control group p-value

n=60 n=60

Birth weight (grams) 3097.8±548.2 3203.3±414.6 0.878

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Birth weight percentile 54.1±27.9 57.3±25.7 0.933

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LGA, n (%) 7 (11.6) 7 (11.6) >0.99

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Neonatal hospitalization (days) 3.9±2 3.8±1.2 0.966

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NICU admission, n (%) 6 (10) 7 (11.6) >0.99
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Hypoglycemia of the newborn, n (%) 2 (3.3) 1 (1.7) >0.99
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Respiratory morbidity *, n (%) 4 (6.6) 2 (3.3) 0.680

Phototherapy, n (%) 2 (3.3) 4 (6.6) 0.680

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Neonatal death, n (%) 0 0 >0.99

Composite adverse outcome**, n (%) 7 (11.7) 11 (18.3) 0.444

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All data are shown as number (%), or mean ± standard deviation. LGA- large for gestational age,
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NICU- neonatal intensive care unit. *Respiratory morbidity includes- respiratory distress syndrome,

transient tachypnea of the newborn, mechanical ventilation, or need for respiratory support. **

Composite adverse neonatal outcome was defined as the presence of one or more of the following:

hypoglycemia of the newborn, respiratory morbidity, phototherapy, or neonatal death.

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Figure 1 – Study design

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