Person‐centred, web‐based support in pregnancy and early motherhood for women with Type 1 diabetes mellitus: a randomized controlled trial

AIMS To report results from and explore use of a multicentre, parallel-group, unblinded, randomized controlled trial testing the effectiveness in terms of well-being and diabetes management of a person-centred, web-based support programme for women with Type 1 diabetes, in pregnancy and postpartum. METHODS Between 2011 and 2014, 174 pregnant women with Type 1 diabetes were randomly allocated (1:1) to web-based support and standard care (intervention group, n=83), or standard care (control group, n=91). The web-based support consisted of evidence-based information; a self-care diary for monitoring of daily activities; and peer support in a discussion forum. The primary outcomes (mean difference, measured at 6 months after childbirth) were well-being and diabetes management. RESULTS No differences were found with regard to the primary outcome measure scores for general well-being [1.04 (95% CI -1.28 to 3.37); P=0.68] and self-efficacy of diabetes management [0.08 (95% CI -0.12 to 0.28); P= 0.75], after adjustment for baseline differences in the insulin administration method, nor with regard to the secondary outcome measures. CONCLUSIONS At 6 months after childbirth, the web-based support plus standard care was not superior to standard care in terms of general well-being or self-efficacy of diabetes management. This might be explained by the low number of participants who had a high activity level. Few simultaneously active participants in the web-based programme and stressors in motherhood and diabetes postpartum were the main barriers to its use. Further intervention studies that offer web-based support are needed, with lessons learned from the present study. (Clinicaltrials.gov identification number: NCT015665824).