Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial.

BACKGROUND Treatment of hyperglycemia in women with gestational diabetes mellitus GDM is associated with improved maternal and neonatal outcomes and requires intensive clinical input This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits OBJECTIVE We conducted a randomized controlled trial to determine whether the use of a mobile phone based real time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance METHODS Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone based blood glucose management solution GDm health the intervention or routine clinic care The primary outcome was change in mean blood glucose in each group from recruitment to delivery calculated with adjustments made for number of blood glucose measurements proportion of preprandial and postprandial readings baseline characteristics and length of time in the study RESULTS A total of 203 women were randomized Blood glucose data were available for 98 intervention and 85 control women There was no significant difference in rate of change of blood glucose 0 16 mmol L in the intervention and 0 14 mmol L in the control group per 28 days P 78 Women using the intervention had higher satisfaction with care P 049 Preterm birth was less common in the intervention group 5 101 5 0 vs 13 102 12 7 OR 0 36 95 CI 0 12 1 01 There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group 27 101 26 7 vs 47 102 46 1 P 005 Other glycemic maternal and neonatal outcomes were similar in both groups The median time from recruitment to delivery was similar intervention 54 days control 49 days P 23 However there were significantly more blood glucose readings in the intervention group mean 3 80 SD 1 80 and mean 2 63 SD 1 71 readings per day in the intervention and control groups respectively PUnder 001 There was no significant difference in direct health care costs between the two groups with a mean cost difference of the intervention group compared to control of 1044 95 CI 2186 to 99 There were no unexpected adverse outcomes CONCLUSIONS Remote blood glucocse monitoring in women with GDM is safe We demonstrated superior data capture using GDm health Although glycemic control and maternal and neonatal outcomes were similar women preferred this model of care Further studies are required to explore whether digital health solutions can promote desired self management lifestyle behaviors and dietetic adherence and influence maternal and neonatal outcomes Digital blood glucose monitoring may provide a scalable practical method to address the growing burden of GDM around the world TRIAL REGISTRATION ClinicalTrials gov NCT01916694 https clinicaltrials gov ct2 show NCT01916694 Archived by WebCite at http www webcitation org 6y3lh2BOQ