Remote Patient Monitoring For Management of Diabetes Melitus in Pregnancy

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Original Research ajog.

org

OBSTETRICS
Remote patient monitoring for management of diabetes
mellitus in pregnancy is associated with improved
maternal and neonatal outcomes
Agata Kantorowska, MD; Koral Cohen, BA; Maxwell Oberlander, BA; Anna R. Jaysing, BA; Meredith B. Akerman, MS;
Anne-Marie Wise, NP; Devin M. Mann, MD; Paul A. Testa, MD; Martin R. Chavez, MD; Anthony M. Vintzileos, MD;
Hye J. Heo, MD

BACKGROUND: Diabetes mellitus is a common medical complication intraventricular hemorrhage, necrotizing enterocolitis, sepsis, pneumonia,
of pregnancy, and its treatment is complex. Recent years have seen an seizures, hypoxic ischemic encephalopathy, shoulder dystocia, trauma,
increase in the application of mobile health tools and advanced technol- brain or body cooling, and neonatal intensive care unit admission). Sec-
ogies, such as remote patient monitoring, with the aim of improving care ondary outcomes were measures of glycemic control and the individual
for diabetes mellitus in pregnancy. Previous studies of these technologies components of the primary composite outcomes. We also performed a
for the treatment of diabetes in pregnancy have been small and have not secondary analysis in which the patients who used the two different
clearly shown clinical benefit with implementation. remote patient monitoring options (device integration vs manual entry)
OBJECTIVE: Remote patient monitoring allows clinicians to monitor pa- were compared. Chi-square, Fisher’s exact, 2-sample t, and Mann-
tients’ health data (such as glucose values) in near real-time, between office Whitney tests were used to compare the groups. A result was consid-
visits, to make timely adjustments to care. Our objective was to determine if ered statistically significant at P<.05.
using remote patient monitoring for the management of diabetes in pregnancy RESULTS: Maternal baseline characteristics were not significantly
leads to an improvement in maternal and neonatal outcomes. different between the remote patient monitoring and paper groups aside
STUDY DESIGN: This was a retrospective cohort study of pregnant from a slightly higher baseline rate of chronic hypertension in the remote
patients with diabetes mellitus managed by the maternal-fetal medicine patient monitoring group (6.1% vs 1.2%; P=.011). The primary outcomes
practice at one academic institution between October 2019 and April of composite maternal and composite neonatal morbidity were not
2021. This practice transitioned from paper-based blood glucose logs to significantly different between the groups. However, remote patient
remote patient monitoring in February 2020. Remote patient monitoring monitoring patients submitted more glucose values (177 vs 146; P=.008),
options included (1) device integration with Bluetooth glucometers that were more likely to achieve glycemic control in target range (79.2% vs
automatically uploaded measured glucose values to the patient’s Epic 52.0%; P<.0001), and achieved the target range sooner (median, 3.3 vs
MyChart application or (2) manual entry in which patients manually logged 4.1 weeks; P¼.025) than patients managed with paper logs. This was
their glucose readings into their MyChart application. Values in the achieved without increasing in-person visits. Remote patient monitoring
MyChart application directly transferred to the patient’s electronic health patients had lower rates of preeclampsia (5.8% vs 15.0%; P¼.0006) and
record for review and management by clinicians. In total, 533 patients their infants had lower rates of neonatal hypoglycemia in the first 24 hours
were studied. We compared 173 patients managed with paper logs to 360 of life (29.8% vs 51.7%; P<.0001).
patients managed with remote patient monitoring (176 device integration CONCLUSION: Remote patient monitoring for the management of
and 184 manual entry). Our primary outcomes were composite maternal diabetes mellitus in pregnancy is superior to a traditional paper-based
morbidity (which included third- and fourth-degree lacerations, cho- approach in achieving glycemic control and is associated with improved
rioamnionitis, postpartum hemorrhage requiring transfusion, postpartum maternal and neonatal outcomes.
hysterectomy, wound infection or separation, venous thromboembolism,
and maternal admission to the intensive care unit) and composite neonatal Key words: device integration, euglycemia, glycemic control, glycemic
morbidity (which included umbilical cord pH <7.00, 5 minute Apgar score surveillance, hyperglycemia, large for gestational age, mobile health,
<7, respiratory morbidity, hyperbilirubinemia, meconium aspiration, neonatal hypoglycemia, normoglycemia, telehealth, telemedicine

Introduction allowing clinicians to remotely monitor


Cite this article as: Kantorowska A, Cohen K, Oberlander In response to the COVID-19 pandemic, patients’ health data in near real-time
M, et al. Remote patient monitoring for management of the use of telehealth technology to pro- and to make timely adjustments in the
diabetes mellitus in pregnancy is associated with vide medical services to patients management of acute or chronic condi-
improved maternal and neonatal outcomes. Am J Obstet remotely or in mobile settings has tions, between office visits.5 The use of
Gynecol 2023;228:726.e1-11.
markedly expanded,1e4 and patient and RPM technology for the management of
0002-9378/$36.00 clinician satisfaction with the use of diabetes mellitus in the nonpregnant
ª 2023 Elsevier Inc. All rights reserved.
https://doi.org/10.1016/j.ajog.2023.02.015
telemedicine in obstetrics has also been population has been well-studied, with
demonstrated.1,4 Remote patient moni- demonstration of improvement in the
toring (RPM) is a telehealth modality clinical outcomes.6,7 In pregnant pa-
that enhances home-based care, tients, studies examining the use of

726.e1 American Journal of Obstetrics & Gynecology JUNE 2023


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ajog.org OBSTETRICS Original Research

Materials and Methods


AJOG at a Glance
This was a retrospective cohort study of
Why was this study conducted? pregnant women with diabetes mellitus
This study was conducted to determine if remote patient monitoring (RPM) for managed by a maternal-fetal medicine
outpatient management of diabetes mellitus in pregnancy could lead to practice at NYU Langone HospitaleLong
improvement in maternal and neonatal outcomes. Island in Mineola, New York between
October 2019 to April 2021. This practice
Key findings provides comprehensive diabetes care,
RPM for management of diabetes mellitus in pregnancy led to achievement of including outpatient glycemic surveil-
target-range glycemic levels in a shorter time frame, lower rates of maternal lance. Beginning in February 2020, the
preeclampsia, and lower rates of neonatal hypoglycemia when compared with practice implemented the use of an elec-
traditional management. tronic health record (EHR)-based RPM
platform for glycemic surveillance (Epic,
What does this add to what is known?
Verona, WI). Only new patients entering
We demonstrated that the use of RPM technology for outpatient management of
the practice were enrolled in the RPM
diabetes mellitus in pregnancy is superior to traditional paper-based glucose logs
program, allowing for a clear transition
for achieving glycemic control and is associated with improved maternal and
in management. The study received
neonatal outcomes.
exemption from the Institutional Review
Board at the NYU Langone Hospital.
Before RPM implementation, patients
technological innovations, such as RPM, hyperbilirubinemia, birth injury, and recorded their blood glucose values us-
and smartphone-based feedback, for the neonatal intensive care unit (NICU) ing paper logs and submitted these logs
management of diabetes mellitus have admission.29e32 These serious clinical to the practice using e-mail, fax, patient
been small.5,8e13 These studies have outcomes directly correlate with the de- EHR portals (MyChart via Epic), or
predominantly shown that telehealth gree of maternal glycemic control during brought them in during their in-person
modalities are not worse than standard pregnancy33e35 with tight glycemic visit. After implementation of the EHR-
management of diabetes mellitus in control having been shown to reduce integrated RPM platform, near real-time
pregnancy.14 Multiple studies report adverse outcomes.36e40 However, transmission of patient glucose values
high patient satisfaction with these achieving euglycemia in pregnancy can occurred via one of two RPM options.
tools10,11,15 and several have shown im- be challenging. Patients have a limited The first option was 1) device integra-
provements in select parameters of time frame to attain proficiency with tion, which leveraged Bluetooth-enabled
maternal glycemic control.9,13,14 How- diabetic self-management, especially in glucometers that linked with the EHR-
ever, the current data have not clearly the case of GDM, which is diagnosed in based patient portal application
demonstrated improvements in clinical the late second or early third trimester. (MyChart). Once a connection was
outcomes for obstetrical patients with This limited time frame also holds true established, all glucose readings from the
diabetes mellitus managed by these for clinicians, who typically rely on glucometer were transmitted directly to
advanced technologies. patient-reported glucose logs for sur- the patient’s EHR in real time. These
Diabetes mellitus is one of the most veillance and medical management of values became clearly visible to clinicians
common medical complications of diabetes mellitus. This makes diabetes and patients to track their health and to
pregnancy; 1% to 2% of women enter mellitus in pregnancy a difficult entity to adjust medical management as needed.
pregnancy with a diagnosis of type 1 or treat, and there is wide variation re- For patients whose insurance did not
type 2 diabetes, and 6% to 10% of all ported in patients’ ability to adhere to cover Bluetooth-enabled glucometers,
pregnant patients in the United States go treatment and achieve glycemic they were instructed on 2) manual entry
on to develop gestational diabetes mel- control.41e44 of each measured glucose reading into
litus (GDM).16e18 Moreover, the rate of Our objective was to determine if the EHR-based patient portal applica-
diabetes mellitus in pregnancy is rising, using RPM for the management of tion (MyChart), which also transmitted
paralleling the rise in maternal obesity diabetes mellitus in pregnancy could these readings to the patient’s EHR in
and overall type 2 diabetes mellitus.19e24 alleviate some of these barriers and near real-time for review by clinicians.
Pregnant patients with diabetes mellitus lead to improvement in glycemic Regarding management, before RPM
are at increased risk for preeclampsia, control and clinical outcomes. We implementation, any received logs were
shoulder dystocia, obstetrical lacera- hypothesized that using RPM for the reviewed and scanned into the patients’
tions, and cesarean delivery.17,25e28 management of diabetes mellitus in EHR twice a week. Post implementation,
Infants of mothers with diabetes melli- pregnancy is associated with leveraging the EHR-based clinician
tus have increased rates of stillbirth, improved maternal and neonatal communication hub and task manager
macrosomia, neonatal hypoglycemia, outcomes. (InBasket), the same clinical team could

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Original Research OBSTETRICS ajog.org

review the glucose logs at a designated practice. Exclusion criteria included pa- RPM platform. The 360 patients in the
frequency (1 to 2 times a week). A key tients who declined to send any logs for RPM group were the ones enrolled in the
difference was that when a patient review to the practice, those who were program between February 2020 and
inputted values that were outside a range lost to follow-up, or those who delivered April 2021 (the study endpoint). We
of set parameters (blood glucose of >140 at an outside institution; 34 patients were also performed a secondary analysis
and <60), the clinical team was alerted excluded based on these criteria comparing patients who used the two
via InBasket and the patient’s (Figure 1). A total of 533 subjects were different RPM options, namely 184 pa-
RPMebased glucose data could be included in our primary analysis, with tients who used manual entry vs 176 who
reviewed more expeditiously by the 173 patients managed with traditional used device integration.
team. During the study time frame, there paper glucose logs and 360 patients Data on maternal demographics
were no other changes implemented in managed using the EHR-integrated RPM (Table 1), measures of glycemic control,
diabetic management, and the same platform. The 173 patients managed and obstetrical outcomes were extracted
team provided diabetes care. with paper logs were the patients from the patients’ charts. Data on
Between October 2019 and April 2021, managed by the practice between neonatal outcomes were collected from
567 patients with GDM and type II dia- October 2019 and February 2020 before record review of the infants’ charts.
betes mellitus were managed by the implementation of the EHR-integrated Glycemic measures collected included
number of blood glucose values recor-
ded, mean number of blood glucose
FIGURE 1 values per week, and the number and
Patient groups types of encounters for diabetes mellitus
management (see full list of variables in
Table 2). Glycemic control was defined as
having at least two consecutive encoun-
ters where the patient’s blood glucose
report showed that the majority (70%)
of values were in target range, and no
adjustments were made to the thera-
peutic plan. The number of changes to
glycemic management was defined as
number of changes to medication
regimen.
Obstetrical data collected included
gestational age at delivery, mode of de-
livery, rates of gestational hypertension
and preeclampsia, and the presence of
shoulder dystocia (full list of variables is
shown in Table 3). Neonatal data collected
included birthweight, length, ponderal
index (calculated as kg/m3),45 first
neonatal glucose level, neonatal hypogly-
cemia (blood glucose <40), and presence
of multiple episodes of neonatal hypo-
glycemia in the first 24 hours of life
(variables are shown in Table 4). Birth-
weight percentile was obtained using the
calculator provided by the Fetal Medicine
Foundation for birthweight assess-
ment.46,47 Large for gestational age (LGA)
was defined as birthweight exceeding the
90th percentile.
The primary outcomes for compari-
son between the RPM and paper glucose
Flowchart of patients included in the study. log groups were composite maternal
RPM, remote patient monitoring. morbidity and composite neonatal
Kantorowska. Remote patient monitoring for diabetes mellitus in pregnancy improves outcomes. Am J Obstet Gynecol 2023. morbidity. Composite maternal morbidity
was defined as any of the following

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ajog.org OBSTETRICS Original Research

TABLE 1
Maternal demographics for remote patient monitoring vs paper glucose log groups
Remote patient Paper glucose
Characteristics monitoring (n¼360) logs (n¼173) P value
Age (y) 33.44.8 34.34.65 .054
Pre-pregnancy BMI 30.26.8 29.96.8 .670
BMI on delivery admission 33.66.5 33.56.7 .909
Nulliparity 156 (43.3%) 79 (45.7%) .648
Race and ethnicity:
White, non-Hispanic 174 (48.3%) 78 (45.1%)
African American 44 (12.2%) 17 (9.8%)
Hispanic 44 (12.2%) 29 (16.8%) .615
Asian, Indian, or Pacific Islander 79 (21.9%) 40 (23.1%)
Other 19 (5.3%) 9 (5.2%)
Primary language
English 336 (93.3%) 154 (89.0%)
Spanish 16 (4.4%) 16 (9.3%) .095
Other 8 (2.2%) 3 (1.7%)
Primary OB/GYN:
Faculty 192 (53.3%) 93 (53.7%) 1.000
Private 168 (46.7%) 80 (46.2%)
Insurance type:
Medicaid 93 (25.8%) 45 (26.0%)
Private 241 (66.9%) 107 (61.9%) .163
Other or military 26 (7.2%) 21 (12.1%)
Multiple gestation 7 (1.9%) 5 (2.9%) .538
Chronic HTN 22 (6.1%) 2 (1.2%) .011
Type of diabetes mellitus:
Gestational, A1 or A2 341 (94.7%) 166 (95.9%) .462
Pre-gestational type II 19 (5.3%) 7 (4.1%)
Previous GDM 61 (17.0%) 30 (17.3%) 1.000
Gestational age at initial diabetic encounter (wk) 27.25.9 27.85.5 .286
Hemoglobin A1c (%) before diabetes mellitus diagnosis 5.4 (5.1e5.8) 5.4 (5.2e5.7) .841
GCT value 164 (147e187) 167 (151e190) .453
GTT values:
Fasting value 86 (78e95) 88 (77e96) .816
Hour 1 201 (188e214) 202 (186e210) .787
Hour 2 172 (159e190) 176 (162e197) .169
Hour 3 134 (110e153) 139 (119e156) .054
Non-normally distributed continuous variables were presented as median (25the75th percentiles) and normally distributed variables were presented as meanstandard deviation; categorical
variables were presented as frequency (percentage).
BMI, body mass index; GCT, glucose challenge test; GDM, gestational diabetes mellitus; GTT, glucose tolerance test; HTN, hypertension; OB/GYN, obstetrician-gynecologist.
Kantorowska. Remote patient monitoring for diabetes mellitus in pregnancy improves outcomes. Am J Obstet Gynecol 2023.

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Original Research OBSTETRICS ajog.org

TABLE 2
Glycemic control characteristics of study groups: standard diabetic management with paper glucose logs vs remote
patient monitoring
Remote patient monitoring Paper glucose logs
Characteristics (n¼360) (n¼173) P value
Percentage of mothers who achieved glycemic control a
285 (79.2%) 90 (52.0%) <.0001
Number of blood glucose values recorded 177 (116e260) 146 (95e235) .008
Mean number of glucose values per wk 22.6 (17.5e26.2) 22.3 (18.4e25.8) .685
Number of encounters for management of diabetes mellitus:
In-person 0 (0e1) 2 (2e3) <.0001
Telemedicine 3 (1e3) 0 (0e0) <.0001
Phone calls or messages 9 (6e14) 5 (3e9) <.0001
Total 12 (9e17) 8 (5e12) <.0001
a
Number of weeks until glycemic control achieved 3.3 (2.1e5.5) 4.1 (2.6e6.8) .025
a
Gestational age when glycemic control achieved 32.7 (30.3e34.7) 32.8 (30.4e35.9) .472
Percentage of mothers who were started on metformin 100 (27.8%) 48 (27.8%) .994
Percentage of mothers who were started on insulin 103 (28.7%) 49 (28.3%) .930
Final insulin dose (units) 36 (16e58) 44 (23e60) .195
Number of changes to glycemic management 4 (2e10) 4 (2e8) .455
Non-normally distributed continuous variables were presented as median (25the75th percentiles) and normally distributed variables were presented as meanstandard deviation; categorical
variables were presented as frequency (percentage).
a
Defined as 2 consecutive patient encounters with majority of blood glucose values in target range and no changes to diabetic management.
Kantorowska. Remote patient monitoring for diabetes mellitus in pregnancy improves outcomes. Am J Obstet Gynecol 2023.

maternal complications: third- or fourth- normally distributed continuous vari- proportion of patients with chronic hy-
degree perineal laceration, chorioamnio- ables; frequencies and percentages for pertension (6.1% vs 1.2%; P¼.011).
nitis or endometritis, postpartum categorical variables) were calculated Comparisons between the groups for
hemorrhage requiring blood transfusion, separately for each group (RPM vs paper glycemic control variables are shown in
postpartum hysterectomy, wound infec- logs and manual entry vs device inte- Table 2. Patients in the RPM group had
tion or separation, venous thromboem- gration). Univariate analyses were per- more blood glucose values available for
bolism, and maternal admission to the formed using chi-square or Fisher’s exact review than patients who submitted
ICU.48 Composite neonatal morbidity was tests, as deemed appropriate, for cate- paper logs (median, 177 vs 146;
defined as any of the following neonatal gorical variables and the 2-sample t test P¼.008). The RPM group had less in-
complications: umbilical cord pH <7.00, 5 or Mann-Whitney test for continuous person visits than the paper log group
minute Apgar score <7, respiratory measures. A result was considered sta- and, instead, relied more on telehealth
morbidity, hyperbilirubinemia requiring tistically significant at a P value <.05. All platforms (with an increase in tele-
phototherapy, meconium aspiration, analyses were performed using SAS medicine and virtual contacts). Patients
intraventricular hemorrhage, necrotizing (version 9.4) (SAS Institute Inc, Cary, managed with RPM were significantly
enterocolitis, sepsis, pneumonia, seizures, NC). more likely to achieve glycemic control
hypoxic ischemic encephalopathy, shoul- than patients with paper glucose logs
der dystocia, trauma, brain or body cool- Results (79.2% vs 52.0%; P<.0001). Patients in
ing, and NICU admission.48 Secondary The maternal demographic characteris- the RPM group also achieved the gly-
outcomes included measures of glycemic tics are shown in Table 1. Overall, the cemic target in a shorter time period
control, as previously described, and in- maternal baseline characteristics were than the patients managed with paper
dividual obstetrical and neonatal not significantly different between the glucose logs (median, 3.3 weeks vs 4.1
outcomes. RPM and paper glucose log groups, weeks; P¼.025).
The overall descriptive statistics including similar rates of GDM (94.7% Pregnancy, delivery, and maternal
(meanstandard deviation for normally vs 95.9%) and pregestational diabetes outcomes are shown in Table 3.
distributed continuous variables and mellitus (5.3% vs 4.1%). The RPM Mothers with diabetes mellitus in
median and interquartile range for non- group did have a significantly higher pregnancy managed using RPM had a

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TABLE 3
Pregnancy, delivery, and maternal outcomes: standard diabetic management with paper glucose logs vs remote
patient monitoring
Remote patient Paper glucose
Outcomes monitoring (n¼360) logs (n¼173) P value
Antenatal corticosteroids 26 (7.2%) 9 (5.2%) .378
Gestational hypertension 21 (5.8%) 5 (2.9%) .201
Preeclampsia 21 (5.8%) 26 (15.0%) .0008
Gestational age at delivery (wk) 38.31.7 38.41.5 .543
Induction of labor 136 (37.8%) 58 (33.5%) .340
Mode of delivery:
NSVD 187 (51.9%) 82 (47.4%)
Operative delivery 6 (1.7%) 6 (3.5%) .451
Cesarean delivery 162 (45.0%) 82 (47.4%)
VBAC 5 (1.4%) 3 (1.7%)
Third- or fourth-degree laceration 7 (1.9%) 3 (1.7%) 1.000
Shoulder dystocia 2 (0.6%) 2 (1.2%) .599
Chorioamnionitis or endometritis 6 (1.7%) 7 (4.1%) .131
Postpartum hemorrhage requiring blood transfusion 5 (1.4%) 3 (1.7%) .719
Postpartum hysterectomy 0 0 1.000
Wound infection or separation 0 0 1.000
VTE 0 0 1.000
Maternal admission to ICU 1 (0.28%) 0 (0.0%) 1.000
a
Composite maternal morbidity :
0 342 (95.0%) 160 (92.5%)
1 17 (4.7%) 13 (7.5%) .378
2 1 (0.3%) 0 (0.0%)
Non-normally distributed continuous variables were presented as median (25the75th percentiles) and normally distributed variables were presented as meanstandard deviation; categorical
variables were presented as frequency (percentage).
ICU, Intensive Care Unit; NSVD, normal spontaneous vaginal delivery; VBAC, vaginal birth after cesarean; VTE, venous thromboembolism.
a
Composite maternal morbidity based on the following variables: third- or fourth-degree laceration, chorioamnionitis o endometritis, postpartum hemorrhage requiring blood transfusion, postpartum
hysterectomy, wound infection or separation, VTE, and maternal admission to ICU.
Kantorowska. Remote patient monitoring for diabetes mellitus in pregnancy improves outcomes. Am J Obstet Gynecol 2023.

significantly lower rate of preeclampsia with diabetes mellitus managed using proportion of LGA in the RPM group,
than patients managed with paper RPM developed hypoglycemia (glucose but this did not reach statistical signifi-
glucose logs (5.8% vs 15.0%; P¼.0006). <40 in the first 24 hours of life) at a cance. Other neonatal outcomes, such as
This is despite the higher baseline significantly lower rate than infants of Apgar scores, NICU admission, hyper-
proportion of patients with chronic mothers managed using paper glucose bilirubinemia requiring phototherapy,
hypertension in the RPM group. Other logs (29.8% vs 51.7%; P<.0001). Infants and composite neonatal morbidity were
pregnancy and delivery outcomes, such of mothers managed using RPM were not significantly different.
as mode of delivery, rate of shoulder also found to have a significantly lower Figure 2 depicts a graphic represen-
dystocia, and composite maternal median birthweight percentile than in- tation of the statistically significant re-
morbidity did not reach statistical fants of mothers managed using paper sults. Mothers with diabetes mellitus
significance. logs (45.5% vs 56%; P¼.048). The rate managed using RPM had a markedly
Neonatal outcomes for the two groups of LGA infants in the two groups increased rate of achieving glycemic
are shown in Table 4. Infants of mothers showed a trend toward decreased control. This was associated with a

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TABLE 4
Neonatal outcomes: comparison of standard diabetic management with paper glucose logs vs remote patient
monitoring
Remote patient Paper glucose
Outcomes monitoring (n¼360) logs (n¼173) P value
Birthweight (g) 3184.9535.4 3264.1507.3 .104
Birthweight percentile 45.5 (23e73) 56 (26e78) .048
Ponderal index 3.07.1 2.50.3 .283
LGA 43 (11.9%) 23 (13.3%) .658
Apgar, 1 min 9 (9e9) 9 (9e9) .643
Apgar, 5 min 9 (9e9) 9 (9e9) .406
First neonatal glucose:
<30 16 (4.5%) 4 (2.3%)
30e45 65 (18.1%) 41 (23.8%) .173
>45 278 (77.4%) 121 (73.8%)
Neonatal hypoglycemia 107 (29.8%) 89 (51.7%) <.0001
Multiple episodes of hypoglycemia in first 24 h 50 (46.7%) 39 (43.8%) .818
Hyperbilirubinemia requiring phototherapy 47 (13.1%) 33 (19.1%) .069
Umbilical cord pH <7.00 1 (0.3%) 2 (1.5%) .205
5 min Apgar <7 3 (0.8%) 1 (0.6%) 1.000
Respiratory morbidity 24 (6.7%) 16 (9.3%) .294
Meconium aspiration 0 (0.0%) 0 (0.0%) 1.000
Intraventricular hemorrhage 3 (0.9%) 2 (1.2%) .662
Necrotizing enterocolitis 1 (0.3%) 0 (0.0%) 1.000
Sepsis 1 (0.3%) 1 (0.6%) .544
Pneumonia 0 (0.0%) 1 (0.6%) .323
Seizures 0 (0.0%) 0 (0.0%) 1.000
Hypoxic ischemic encephalopathy 0 (0.0%) 1 (0.6%) .325
Trauma 1 (0.3%) 2 (1.2%) .248
Brain or body cooling 0 (0.0%) 1 (0.6%) .325
NICU admission 66 (18.3%) 39 (22.5%) .524
a
Composite neonatal morbidity 0.420.82 0.581.03 .100
Neonatal hospitalization (d) 3.47.3 3.77.4 <.0001
Non-normally distributed continuous variables were presented as median (25the75th percentiles) and normally distributed variables were presented as meanstandard deviation; categorical
variables were presented as frequency (percentage).
LGA, large for gestational age; NICU, neonatal intensive care unit.
a
Composite neonatal morbidity based on the following variables: shoulder dystocia, hyperbilirubinemia requiring phototherapy, umbilical cord pH <7.00, 5 min APGAR <7, respiratory morbidity,
meconium aspiration, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, pneumonia, seizures, hypoxic ischemic encephalopathy, trauma, brain or body cooling, and NICU admission.
Kantorowska. Remote patient monitoring for diabetes mellitus in pregnancy improves outcomes. Am J Obstet Gynecol 2023.

decreased rate of maternal preeclam- coverage was noted be different between Comment
psia and a lower rate of neonatal the groups. There was no statistically Principal findings
hypoglycemia. significant difference in any clinical Overall, this study showed that imple-
A secondary analysis comparing the outcomes, demonstrating that clinical mentation of RPM for the management
different modes of RPM (manual entry benefits are still preserved with manual of diabetes mellitus in pregnancy is
vs device integration) is shown in entry of glucose readings into the pa- associated with improvement in clinical
Table 5. Only the type of insurance tient’s health portal. outcomes. The primary outcomes of

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platform that did not communicate with


FIGURE 2
the patients’ EHR. The smartphone
Paper glucose logs vs RPM: significant maternal and neonatal outcomes
group showed a better level of compli-
ance with blood sugar monitoring, lower
mean glucose values, and lower re-
quirements for insulin; there were no
differences in the rates of preeclampsia,
macrosomia, neonatal hypoglycemia,
shoulder dystocia, and other delivery
and neonatal complications between the
groups.9 The lack of a difference in the
clinical maternal and neonatal outcomes
is likely because of the small sample size
in their study population. Our larger
study showed that RPM has positive
clinical effects beyond just improved
measures of maternal glycemic control.
Moreover, the frequency of feedback
described by Miremberg et al9 with daily
review of patients’ blood glucose values
in a different application platform is
Graphic comparison of the clinically significant outcomes in the paper glucose log vs remote patient time-intensive and may not be scalable
monitoring groups. Triple asterisks represent P<.001.
to a larger patient population in a busy
RPM, remote patient monitoring.
Kantorowska. Remote patient monitoring for diabetes mellitus in pregnancy improves outcomes. Am J Obstet Gynecol 2023.
practice. Our study shows that using an
already existing EHR-based RPM plat-
form allows for seamless implementa-
tion without increasing the costs for
composite maternal and neonatal be cost prohibitive for some patients patients. In addition, RPM services
morbidity did not show a statistically because of limitations in insurance within the EHR are reimbursable with
significant difference between the RPM coverage. both technical and professional billing
and traditional paper glucose log codes, allowing practices to be compen-
groups. However, management by RPM Results in the context of what is sated for services performed.
was associated with improvements in known
multiple measures of maternal glycemic This study goes beyond what has previ- Clinical implications
control, including a higher number of ously been published about mobile health This study has important clinical impli-
values recorded, higher number of en- technology for the management of dia- cations with regards to the use of RPM
counters for diabetic management, betes mellitus in pregnancy. Previous and other mobile health tools for the
higher proportion of mothers success- studies were small and predominantly management of diabetes mellitus in
fully achieving glycemic control, and focused on feasibility, patient satisfaction, pregnancy. Although the primary out-
shorter time to achieving glycemic and cost-effectiveness, failing to show comes of composite maternal and
control. In addition, RPM was associ- improvement in clinical outcomes.8,10e13 neonatal morbidity did not show statis-
ated with decreased rates of maternal One of the largest previous studies tically significant differences, this study
preeclampsia, decreased rates of about the implementation of remote revealed improvement in several indi-
neonatal hypoglycemia, and decreased smartphone-based feedback for the vidual clinical outcomes, showing that
neonatal birthweight percentile. No management of diabetes was performed patients with diabetes benefit from being
statistically significant difference was by Miremberg et al.9 They performed a managed with RPM. The composite
noted for other outcomes such as mode randomized controlled trial in which 120 maternal and neonatal outcomes
of delivery, neonatal LGA, or shoulder patients were enrolled—60 who recor- comprised rare clinical events and would
dystocia. ded their blood glucose measurements likely require a substantially higher
A secondary analysis comparing the using paper diaries and who came in sample size to show significance.
two modalities of RPM, namely manual biweekly for monitoring visits and 60 We found that RPM leads to better
entry and device integration, did not who entered their glucose values into a maternal glycemic control, decrea-
show a difference in outcomes, demon- smartphone-based application and sed rates of preeclampsia, decreased
strating that these clinical outcomes are received daily feedback regarding their neonatal hypoglycemia, and decreased
preserved even without the benefit of a glycemic control. This smartphone- neonatal birthweight percentile. Patients
device-integrated glucometer that may based application was a separate who were managed using RPM reaped all

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TABLE 5
Comparison of remote patient monitoring for diabetes: manual entry vs device integration
Manual entry of glucose Device integration
Characteristics values (n¼184) (n¼176) P value
Insurance type:
Medicaid 62 (33.7%) 31 (17.6%)
Private 113 (61.4%) 128 (72.7%) .0014
Other or military 9 (4.9%) 17 (9.7%)
a
Percentage of mothers who achieved glycemic control 147 (79.9%) 138 (78.4%) .729
Number of blood glucose values recorded 168 (111e244) 183 (126e271) .172
Number of encounters for management of diabetes mellitus:
In-person 0 (0e1) 0 (0e1) .292
Telemedicine 2 (1e3) 3 (1e3) .573
Phone calls or messages 9 (6e13) 9 (6e15) .347
Total 12 (9e16) 13 (9e19) .294
Number of weeks until glycemic controla achieved 3.2 (2.1e6.2) 3.3 (2.2e5.3) .583
Rate of preeclampsia (%) 9 (4.9%) 12 (6.8%) .059
Rate of neonatal hypoglycemia (%) 57 (31.2%) 50 (28.4%) .571
Birthweight percentile 46.630.7 48.928.5 .450
Non-normally distributed continuous variables were presented as median (25the75th percentiles) and normally distributed variables were presented as meanstandard deviation; categorical
variables were presented as frequency (percentage).
a
Defined as 2 consecutive patient encounters with the majority of blood glucose values in the target range and no changes to diabetes mellitus management.
Kantorowska. Remote patient monitoring for diabetes mellitus in pregnancy improves outcomes. Am J Obstet Gynecol 2023.

these benefits without needing to in- application for recording their values management of diabetes in pregnancy
crease their in-person encounters. These and clinicians do not need to log into a was equally effective at improving gly-
results suggest that use of RPM and other separate system to view these values or to cemic control and improving maternal
types of advanced technologies should make adjustments to therapeutic man- and neonatal outcomes. However, larger
become more widespread in the care of agement. RPM allows review of data and studies are needed to confirm this
pregnant women. RPM gives clinicians a updates to a patient’s therapeutic plan as particular finding.
superior platform to review patients’ frequently as needed, even between
health data—they no longer have to rely visits. Research implications
on a patient remembering to write down It is important to note that the two Future studies should focus on scaling
their blood sugar levels on a piece of types of RPM modalities, manual entry and generalizing these data. Imple-
paper or to bring that paper in during and device integration, did not show a mentation of RPM for the management
clinical visits. Smartphones are ubiqui- significant difference in any clinical of diabetes mellitus in pregnancy at
tous in our modern world,49,50 meaning outcomes when compared with each other institutions would reveal the
that patients managed with RPM do not other. Insurance coverage dictated feasibility of this approach in the context
have to reach far to record their blood whether patients could be provided with of individual hospital infrastructure and
glucose values. Or, in the case of device Bluetooth-enabled glucometers. Our would strengthen the current findings.
integration, they no longer have to results suggest that although there is Examining larger cohorts of patients
remember to record anything at all inequity among patients enrolling in may also reveal statistical significance for
because their Bluetooth glucometer RPM based on their insurance coverage, rarer outcomes, such as the various
automatically uploads the measured the overall care they received and their components of the maternal and
values. RPM that is integrated into a clinical outcomes were equitable. neonatal composite morbidities.
patient’s health portal application is Although reimbursement for RPM ser- It would also be interesting to obtain
additionally beneficial because every- vices requires use of device-integrated data on patient satisfaction with RPM,
thing is in a central location. The patient platforms, we found that manual entry particularly from patients who may have
does not need to rely on a separate of recordings using RPM for the had a pregnancy managed by standard

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ajog.org OBSTETRICS Original Research

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Gestational diabetes: the consequences of not pregnancies complicated by type 2 and [email protected]

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