Background
Suboptimal management and control of type 2 diabetes in primary care has been acknowledged in China. In 2017, a cluster randomised controlled trial, ROAd to hierarchical Diabetes Management At Primary care (ROADMAP) study was launched to test the effectiveness and feasibility of an integrated, service provider empowering, hierarchical diabetes management model in primary care setting.

Aim 
To describe the trial participants’ characteristics as baseline. 

Methods
ROADMAP study employed a community-based, cluster randomised controlled trial design. Participants were patients with T2D aged 18-75. An average of 22 patients were randomly selected from each local community diabetes registry. Six communities were selected from each participating county. Six counties in each province participate the study, covering developed/less-developed, urban/rural areas across the most provinces (25 out of 31 provinces) in mainland China. Communities (as cluster) within each selected county are randomly assigned to either intervention or usual care () in a 2:1 allocation ratio. The intervention enables three-tiered care teams to deliver standardized blood glucose monitoring and referral services, supported by a mobile health information system, and receives performance review for service delivery. First patient was enrolled in July 2017. It took one year to complete site initiations for each province. All study sites would be followed-up for the following 12 months. The primary outcome is glycated haemoglobin (HbA1c) control at 12 months. Secondary outcomes include levels and control rates of ABC (HbA1c, blood pressure and LDL-c) targets and fasting blood glucose. 

Results
19601 eligible participants from 864 communities were recruited. 19584 participants completed baseline assessment and entered analysis, including 25.7% from areas of developed urban, 24.3% from less-developed urban, 19.4% from developed rural and 30.6% from less-developed rural. Among these participant, 58.7% were female, mean age was 60.5 (SD 8.4) years, and mean duration of diabetes was 7.4 (SD 6.0) years, 78.2% were taking OAD, and 24.3% were on insulin therapy. The percentages of participants who self-reported previous diagnosis of diabetes related complications were 18.3% for cardiovascular disease (including carotid artery disease, coronary stenosis, myocardial infarction, post coronary artery surgery, cerebral infarction, cerebral haemorrhage, transient ischemic attack), 7.1% for diabetic nephropathy, 11.5% for diabetic retinopathy, 7.4% for diabetic peripheral neuropathy, 1.7% for diabetic food damage. 37.3% of the participants had a <7.0% HbA1c level. The percentages of who achieved Background
Suboptimal management and control of type 2 diabetes in primary care has been acknowledged in China. In 2017, a cluster randomised controlled trial, ROAd to hierarchical Diabetes Management At Primary care (ROADMAP) study was launched to test the effectiveness and feasibility of an integrated, service provider empowering, hierarchical diabetes management model in primary care setting.

Aim 
To describe the participants’ characteristics as baseline. 
Methods
ROADMAP study employed a community-based, cluster randomised controlled trial design. Participants were patients with T2D aged 18-75. An average of 22 patients were randomly selected from each local community diabetes register. Six communities were selected from each county. Six counties in each province participate the study, covering developed/less-developed, urban/rural areas across the most provinces (25 out of 31 provinces) in mainland China. Communities within each selected county are randomly assigned to either intervention or usual care in a 2:1 allocation ratio. The intervention enables three-tiered care teams deliver standardized blood glucose monitoring and referral services, supported by a mobile health information system, and receives performance review for service delivery. First patient was enrolled in July 2017. It took one year to complete site initiations for each province. All study sites would be followed-up for the following 12 months. The primary outcome is glycated haemoglobin (HbA1c) control at 12 months. Secondary outcomes include control rate of ABC (HbA1c, blood pressure and LDL-c) targets and fasting blood glucose. 

Results
19601 eligible participants from 864 communities were recruited. 19576 participants completed baseline assessment and entered analysis, including 25.7% from areas of developed urban, 24.3% from less-developed urban, 19.4% from developed rural and 30.6% from less-developed rural. Among these participant, 58.7% were female, mean age was 60.5 (SD 8.4) years, and mean duration of diabetes was 7.4 (SD 6.0) years, 78.2% were taking OAD, and 24.3% were on insulin therapy. The percentages of participants who self-reported previous diagnosis of diabetes related complications were 18.3% for cardiovascular disease (including carotid artery disease, coronary stenosis, myocardial infarction, post coronary artery surgery, cerebral infarction, cerebral haemorrhage, transient ischemic attack), 7.1% for diabetic nephropathy, 11.5% for diabetic retinopathy, 7.4% for diabetic peripheral neuropathy, 1.7% for diabetic food damage. 37.2% of the participants had a <7.0% HbA1c level. The percentages of who achieved all 3 'ABC' control targets of HbA1c, and blood pressure (< 140/80 mmHg) and LDL-c (< 2.6 mmol/L) were 11.7%. 37.0% of the participants had a < 7.0 mmol/L fasting glucose level.
Conclusions
The large and representative baseline data from patients with established type 2 diabetes confirms that the control rate of blood glucose is still low in primary care in China. We anticipate the innovative and comprehensive intervention in ROADMAP study would contribute to improved blood glucose control in China. Dissemination of the main trial result could be expected in 6 months after the final data collection completes.

Baseline characteristics of a cluster randomized controlled trial for managing diabetes in China: the ROADMAP study