An interventional study of Intensive guideline algorithm implementation and Conventional guideline algorithm implementation in Type 2 Diabetes, Cardiovascular Complication and Diabetic Kidney Disease, sponsored by Shanghai Zhongshan Hospital. Recruiting at 13 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment
The Effects and Safety of Diabetic GUideline Algorithm Implementation in the Community (GUARD-Community) study is a 2-arm, cluster-randomized control trial to evaluate the effect and safety of guideline algorithm intervention performed by primary care physicians on cardiovascular and renal outcomes in elderly patients with high risk in community.
Diabetes is an important public health concern. Elderly diabetic patients are characterized by a long duration and complications, including chronic kidney disease and/or cardiovascular disease. In the past 30 years, the guidelines of CDS, EASD or ADA have been frequently updated. The latest guideline on pharmacological algorithm recommend that patients with cardiovascular, renal disease or very high/high CV risk patients should be treated with anti-diabetic drugs presenting target organ protection, including SGLT2i and GLP1RA. And the guideline recommend comprehensive control of the cardiovascular risk factors, such as hypertension and dyslipidemia.
This GUARD-Community study is a community based cluster-randomized controlled trial and will enroll 5600 or more participants in more than 120 clusters aged ≥ 65 years with T2DM and complicated with high/very high cardiovascular risk factors . The trial will evaluate the the effects and safety of intensive "Guideline" algorithm implementation on CVD and renal outcomes. The primary hypothesis is that guideline algorithm intervention implemented by primary care physicians will significantly reduce the risk of 4-point MACE (comprised of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalization of heart failure) rates. In Phase 1 study, the control of blood sugar, blood pressure and lipids will be evaluated at 18 months after intervention. In Phase 2 study, the CVD and renal outcomes will be evaluated at 3 years. The study will last for 4 years.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 5,600 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SGLT2i or GLP-1RA recommended in priority in subjects at very high/high CV risk. The targets of intervention will be achieved at HbA1C \<7%, blood pressure \<130/80mmHg， LDL-c\<1.8mmol/L at very high CV risk or \<2.6mmol/L at high CV risk patients, antiplatelet as secondary prevention of ASCVD.
Other: Intensive guideline algorithm implementation
Treatment based on the current approaches implemented by local physicians(primary care physicians). Guideline based education and consults will be conducted to primary care physicians.
Other: Conventional guideline algorithm implementation
Diabetes guideline pharmacological algorithm will be implemented by primary care physicians in community. In brief, SGLT2i or GLP-1RA will be recommended to control blood glucose in priority when subjects at very high/high CV risk and meet the target HbA1C\<7%, control blood pressure \<130/80mmHg， LDL-c\<1.8mmol/L at very high CV risk patients or \<2.6mmol/L at high CV risk patients, and antiplatelet as secondary prevention of ASCVD.
The guideline intervention is based the guidance which the local physicians followed through self learning and education. The management of diabetes paitients will be decided by local physicians.
Primary Outcome of Phase 1: Comprehensive management effect of various cardiovascular risk factors in T2D，meeting control targets for a combination of A1c, BP, LDL-C.
The proportion of participants with HbA1C\<7.0%, blood pressure\< 130/80 mm Hg，LDL-c\<1.8mmol/L at very high CV risk or \<2.6mmol/L at high CV risk.
Time frame: 18 months since randomization
Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure.
Time to occurrence of cardiovascular and cerebrovascular death, non-fatal myocardial infarction, non-fatal Stroke, hospitalization for heart failure.
Time frame: 3 years since randomization
Secondary Outcome of Phase 1: Glycemic control rate
The proportion of participants with tight glucose control, targeting HbA1c \<7.0%
Time frame: 18 months since randomization
Secondary Outcome of Phase 1: Mean HbA1C changes
Mean HbA1C changes of participants
Time frame: 18 months since randomization
Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes
Mean systolic and diastolic pressure changes of participants
Time frame: 18 months since randomization
Secondary Outcome of Phase 1: Mean LDL-c changes
Mean LDL-c changes of participants
Time frame: 18 months since randomization
Secondary Outcome of Phase 1: Adherence to guideline algorithm medication recommendation rate
Use electronic medical recorded prescription and questionnaires to assess the proportion of participants who adhere to guideline recommended medication
Time frame: 18 months since randomization
Secondary Outcome of Phase 2: Incident or worsening nephropathy
Time to composite of incident macroalbuminuria (UACR \>300 mg/g), a sustained decline in eGFR (decrease in the eGFR of 30% or more to a value of less than 60 when baseline ≥60ml per minute per 1.73 m2, decrease in the eGFR of 50% or more when baseline \<60ml per minute per 1.73 m2)from baseline, or chronic renal replacement therapy, or renal death.
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Cardiorenal composite endpoint
Time to eGFR (CKD-EPI formula) decrease, renal replacement therapy, renal or cardiovascular death
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: 3P MACE
Time to events occurence: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: New onset of macroalbuminuria.
Time to UACR\>300mg/g
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Changes of myocardial ischemia in electrocardiogram (ECG)
Participants number of ECG ischemia demonstration occurence: ST-T segment depression more than 0.1mv in two adjacent leads of ECG compared with baseline, poor R wave progression.
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: New onset of albuminuria
Time to UACR increase from \<30mg/g to ≥30mg/g
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Albuminuria progression
Time to albuminuria progression: UACR increased by ≥30% and grade progression (ie, from normal to micro or macro, or from micro to macro)
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Albuminuria regression
Time to albuminuria regression: UACR grade regression(ie, from macro to micro or normal, or from micro to normal), and the UACR value decreases by more than or equal to 30%
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Changes in the ratio of patients with normal or abnormal urine protein at the end of the study
Rate change of normal or abnormal UACR. Normal means UACR\<30mg/g. Abnormal means UACR≥30mg/g
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Slope of eGFR decline
Decrease of the eGFR over time
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Retinopathy changes
Occurrence or regression of retinopathy(ETDRS-DRSS)
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Body weight change
Absolute weight change and the percentage change of body weight
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Changes of fatty liver prevalence
Rate change of fatty liver.
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Changes in beta-cell function
Absolute change assessed by HOMA2-%β method
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: Changes in cognitive function
Improvement or progression of cognitive function: The Mini-CogTM scale
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: The FRAIL scale
Changes of the simple frailty questionnaire score
Time frame: 3 years since randomization
Secondary Outcome of Phase 2: All-cause death
Time to the death due to any cause
Time frame: 3 years since randomization
Health Economics Indicators
Cost-effectiveness analysis： quantification of Incremental Cost Ratio Life Cycle (ICER) and Quality Adjusted Years (QALYs)
Time frame: 3 years since randomization
Changes in cardiovascular risk indicators
Framingham score
Time frame: 3 years since randomization
Serology and urine testing
Biomarkers associated with diagnosis or prognosis: using "omics" screening.
Time frame: 3 years since randomization
Genomics testing
Gene polymorphism testing for drug response or prognosis: using genome-wide association study(GWAS) screening.
Time frame: 3 years since randomization
The time rate of glycemic target range
Continous glucose monitor detection
Time frame: 3 years since randomization
Plan to share: No — The data will be available from the principle investigator on reasonable request.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Zhongshan Hospital