| BackgroundDiabetes mellitus has become the major globally public health challenge in the past decade,and approximately 425 million people or 8.8%of adults worldwide suffer from it.It is likely to approach 629 million by 2045.Patients with diabetes mellitus have high risk for cardiovascular disease,especially with poor glucose control.Diabetes is a major risk factor for CVD,the leading cause of death in the world.More than 80.0%patients with diabetes mellitus are associated with multiple cardiovascular risk factors,such as obesity,hypertension,dyslipidemia,and the concurrence of arteriosclerotic cardiovascular disease(ASCVD).Previous studies of mobile phone text messaging have been conducted to improve glycaemic control,hypertension,and medication adherence.However,several questions remain about the generalizability of these findings.Most trial to date has been designed to target a single condition;meanwhile most diabetic patients have multiply cardiovascular risk factors,requiring several lifestyle and treatment recommendations.Furthermore,most prior studies have been restricted to single-site intervention on single CVD risk factor,and lacked long-term observation.This randomized controlled clinical trial aims to evaluate the long-term effectiveness of mobile phone text message-based intervention in improving the levels of glycated hemoglobin(HbA1c),systolic blood pressure(SBP)and low density lipoprotein(LDL-c)in diabetic patients with poorly glycaemic controlled and cardiovascular risk factors or clinically symptomatic cardiovascular disease.MethodsThis is a parallel,multicentre,randomized controlled trial that was conducted in five clinical centers.Eligible participants will be randomly assigned into the intervention(text messaging)and the control group(standard treatment)in a 1:1 ratio.The intervention group will receive text messages in addition to usual care for 12 months,while the control group will receive usual care.The messages will target lifestyle recommendation,glucose control,blood pressure control,healthy eating,medication adherence,physical activity and smoking cessation.Each message will be sent on 6 of 7 randomly selected weekdays and arrived at random times the day during working hours.The primary outcome is the combined changes in HbA1C,SBP and LDL-cholesterol levels,simultaneous model using a scaled marginal model.The Secondary outcome includes the net change of CVD risk factors(glycated hemoglobin[HbAlc],systolic blood pressure[SBP],and LDL-cholesterol),and the proportion of participants with HbA1C<7%(<7.5%if with clinical CVD),BP<140/90 mm Hg,and LDL-cholesterol<100 mg/dL,and net change in estimated 10-year risk of CHD and CVD.The primary outcome and secondary outcome will be measured at month 3,6,and 12 visits.ResultsA total of 473 patients with T2DM and high risk of CVD,or clinically symptomatic CVD were recruited in this study.There were 237 patients in the text messaging group and 236 patients in the control group.The baseline characteristics of participants shown no significant differences.Of those,158 patients have completed the 6-month follow-up and were included to analyze.The common effect of the text message intervention on HbA1c,SBP and LDL-c was estimated to be-0.102(SE=0.093),indicating that Text messaging had significantly better the combined effect on the levels of HbA1c,SBP and LDL-c than the control.Furthermore,the text messaging group had significantly lower level of HbAlc than the control group(P<0.05).There were no significant difference in SBP and LDL-c(P>0.05).The proportion of achieved target of glycated hemoglobin<7%(if combined with cardiovascular disease,<7.5%),blood pressure<140/90 mmHg and LDL-c<100mg/dL(2.6mmol/L)also shown no significant difference between the two groups(P>0.05).ConclusionsCompared to usual care,text message can improve the comprehensive control of HbAlc,SBP and LDL-c in diabetic patients with poor glucose control and high cardiovascular risk factors over 6 months. |
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