Elsevier

Clinical Therapeutics

Volume 41, Issue 11, November 2019, Pages 2426-2434
Clinical Therapeutics

Pilot Study
Peripartum Management of Gestational Diabetes Using a Digital Health Care Service: A Pilot, Randomized Controlled Study

https://doi.org/10.1016/j.clinthera.2019.09.005Get rights and content

Abstract

Purpose

The prevalence of gestational diabetes mellitus (GDM) is increasing, and multifaceted interventions are effective in the management of GDM. This study aimed to develop and evaluate a model for the management of GDM with the use of mobile health care.

Methods

This was a prospective, randomized controlled pilot study. A total of 21 patients who were diagnosed with GDM during 24–28 weeks of gestation were randomly divided into a conventional management (CM) group (n = 10) and a mobile management (MM) group (n = 11). The CM group received conventional GDM management and could freely use the mobile health care application. The MM group received mobile health care services, including tailored mobile coaching. After delivery, obstetric outcomes were collected, and 75-g oral glucose tolerance test was performed at 5–12 weeks postpartum.

Findings

Baseline characteristics, including glycosylated hemoglobin (HbA1c), were not significantly different between the 2 groups. No statistically significant differences were found in rates between the 2 groups for (1) neonate large for gestational age and (2) cesarean section at the time of delivery. No significant difference was found in HbA1c between the 2 groups after delivery. However, postpartum homeostatic model assessment insulin resistance, body mass index, weight, and percentage of body fat were significantly lower in the MM group.

Implications

The MM group had no significant difference in glycemic index compared with the CM group. However, the MM group had effective weight control and improved insulin resistance after delivery. This study indicated that mobile health care services could be an efficient GDM management tool. ClinicalTrials.gov identifier: NCT03838380.

Introduction

Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. It is defined as GDM that is first diagnosed in the second or third trimester of pregnancy and that is not clearly overt diabetes before gestation.1, 2 The prevalence of GDM is increasing because of the increasing prevalence of obesity and women bearing children at older reproductive ages. It is well known that GDM is associated with several maternal and neonatal complications. Women with GDM are at higher risk of undergoing cesarean section and developing preeclampsia.3, 4 Moreover, offspring of women with GDM experience higher rates of neonatal hypoglycemia, hyperbilirubinemia, macrosomia, shoulder dystocia, and birth trauma.5 However, the risk of preeclampsia, macrosomia, and shoulder dystocia can be reduced with adequate glycemic control during pregnancy.6, 7 Adequate glycemic control could be achieved with tailored counseling about nutrition, exercise, and medical treatment if needed. Currently, women with GDM measure their blood glucose at least 4 times a day, record the results along with details about their diet, and bring the information to the outpatient clinic for counseling. Recently, in the era of the mobile phone revolution, attempts have been made to improve care in all fields of medicine through mobile phone technology and especially in patients with diabetes.8, 9, 10 If mobile health care applications for the management of GDM are applied, timely management may be expected. However, only a few studies about GDM management with mobile phone technology have been published. The purpose of the present study was to develop and evaluate a model for management of GDM with the use of mobile health care.

Section snippets

Methods

This was a single-center, randomized controlled trial. Patients were recruited from February 2017 to June 2017, and the final delivery occurred August 2017. Singleton pregnant women diagnosed with GDM at 24–28 weeks of gestation were included. GDM was diagnosed with a 2-step approach. Women whose glucose concentrations were >140 mg/dL with a 50-g oral glucose tolerance test (OGTT) underwent a 75- or 100-g diagnostic OGTT. GDM was diagnosed in women who had >1 abnormal value on the 75-g, 2-hour

Results

A total of 21 patients were enrolled in the study, 19 patients completed the study, and 2 patients were lost to follow-up (1 in each group). Ten patients were allocated to the CM group and 11 patients to the MM group. The clinical characteristics of both groups are shown in Table I. No significant difference was found between the 2 groups. Maternal age and fasting glucose at enrollment and the rate of family history of diabetes mellitus were higher in the MM group; however, it was not

Discussion

In the present study, patients with GDM who were allocated to the group assigned the use of a mobile phone application for the management of GDM had lower BMI, weight, percentage of body fat, and IR after delivery compared with a CM group. No significant difference in glycemic control during pregnancy and perinatal outcome between the MM and CM groups.

Management through telemedicine seems to be effective in improving glycemic control in the nonpregnant patient with diabetes.13, 14, 15 A

Conclusions

The present study found that mobile phone-based technology can be used in the management of GDM and is a potentially useful tool for weight control in the postpartum period. Future study will focus on the effect of mobile phone-based platforms on pregnancy and neonatal outcomes with a larger sample size and more advanced platform.

Acknowledgments

The authors wish to thank the entire staff of the Diabetes Clinic and the Department of Obstetrics at Kangbuk Samsung Hospital, Seoul, Korea, for their contributions to this study. The authors are grateful to Mi-Joon Lee, MinJung Lim, Sung A. Min, Eun Mi Kim, and Mj Ju Choi for their dedication and assistance in managing the participants.

The authors thank Dr. Kyung-Soo Kim (Department of Internal Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Korea) for

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