Effect of the Pregnant+ smartphone application in women with gestational diabetes mellitus: a randomised controlled trial in Norway

Iren Borgen, Milada Cvancarova Småstuen, Anne Flem Jacobsen, Lisa Maria Garnweidner-Holme, Seraj Fayyad, Josef Noll, Mirjam Lukasse, Iren Borgen, Milada Cvancarova Småstuen, Anne Flem Jacobsen, Lisa Maria Garnweidner-Holme, Seraj Fayyad, Josef Noll, Mirjam Lukasse

Abstract

Objective: To assess the effect of the Pregnant+ app on the 2-hour glucose level of the routine postpartum oral glucose tolerance test (OGTT) among women with gestational diabetes mellitus (GDM). The Pregnant+ app was designed to provide information about GDM, and promote physical activity and a healthy diet.

Design: A multicentre, non-blinded randomised controlled trial.

Setting: Five diabetes outpatient clinics in the Oslo region.

Participants: Women ≥18 years old with a 2-hour OGTT blood glucose level ≥9 mmol/L who owned a smartphone; understood Norwegian, Urdu or Somali; and were <33 weeks pregnant. A total of 238 women were randomised; 158 women completed the OGTT post partum.

Intervention: The Pregnant+ app and usual care, the control group received usual care.

Primary and secondary outcomes: The primary outcome was the 2-hour blood glucose level of the routine postpartum OGTT. Secondary outcomes reported were mode of delivery, induction of labour, Apgar score, birth weight, transfer to the neonatal intensive care unit and breast feeding practice. Blood glucose levels during pregnancy, knowledge of diabetes, diet and physical activity are not reported.

Results: No difference was found for the 2-hour blood glucose level of the postpartum OGTT, with 6.7 mmol/L (95% CI 6.2 to 7.1) in the intervention group and 6.0 mmol/L (95% CI 5.6 to 6.3) in the control group. The significant difference in the proportion of emergency caesarean sections between the intervention group, 10 (8.8%) and the usual care group, 27 (22.1%), disappeared when adjusted for parity. There were no differences in birth weight, breast feeding practice, obstetric complications or transfer to the intensive neonatal care unit. No adverse events were registered.

Conclusion: The Pregnant+ app had no effect on 2-hour glucose level at routine postpartum OGTT. After controlling for parity, the difference in emergency caesarean section was not statistically significant.

Trial registration number: NCT02588729.

Keywords: diabetes in pregnancy; primary care; reproductive medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Modified Consolidated Standards of Reporting Trials (CONSORT) flow diagram for individual randomised controlled trials of non-pharmacological treatments. max, maximum; min, minimum; OGTT, oral glucose tolerance test.
Figure 2
Figure 2
The start-up screen and home menu of the blood glucose section.
Figure 3
Figure 3
The graphic presentation of blood glucose values page, an example of advice on diet and the home menu of the food and beverage section.

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