Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community

Shanghai Zhongshan Hospital5,600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Interventions

Intensive guideline algorithm implementationOTHER

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.

Conventional guideline algorithm implementationOTHER

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ①Males or females aged 65 and above (≥65) receive treatment from the local community health service center; * ②Diagnosed type 2 diabetes (ADA criteria): * A. Typical symptoms of diabetes + random blood sugar ≥ 11.1mmol/L; * B. Fasting blood glucose (FPG) ≥ 7.0mmol/L (fasting blood glucose is defined as no caloric intake within 8 hours); * C. Oral glucose tolerance test 2h blood glucose (OGTT) ≥ 11.1mmol/L (2h after meal); * D. have been treated with antidiabetic drugs; * Each blood sugar test must be repeated to confirm the diagnosis; * ③Complicated with chronic kidney disease and/or very high/high risk of cardiovascular disease, meet any one of the following: * A. ASCVD, including coronary heart disease, cerebral infarction, peripheral vascular disease; * B. Or target organ damage (albuminuria, renal impairment with eGFR ≥ 30 ml/min/1.73m2, left ventricular hypertrophy or retinopathy); * C. ≥ 3 major risk factors (age ≥ 65 years old, hypertension, dyslipidemia, smoking, obesity ); * D. Diabetes duration ≥ 10 years, with any one traditional cardiovascular risk factor such as advanced age, obesity, smoking, sedentary, family history of cardiovascular disease, hypertension, abnormal lipid metabolism. Exclusion Criteria: * ①Pregnant women or women planning to become pregnant; * ②eGFR\<30 mL/min/1.73m2 (CKD-EPI formula); * ③Patient cannot be followed up for 36 months (due to health condition or migration); * ④Unwilling or unable to sign the informed consent; * ⑤Type 1 diabetes;

Locations (13)

Xiangcheng Second People's Hospital

Suzhou, Jaingsu, China

RECRUITING

Caohu Community Healthcare Center

Suzhou, Jiangsu, China

RECRUITING

Huangqiao Community Healthcare Center

Suzhou, Jiangsu, China

RECRUITING

Xiangcheng People's Hospital.

Suzhou, Jiangsu, China

RECRUITING

Yuanhe Community Healthcare Center

Suzhou, Jiangsu, China

RECRUITING

Xiangcheng Third People's Hospital

Suzhou, Jiangsu, China

RECRUITING

Taiping Community Healthcare Center

Suzhou, Jiangsu, China

RECRUITING

Yangchenghu People's Hospital

Suzhou, Jiangsu, China

RECRUITING

Health Center of Xiangcheng Tourism Resort

Suzhou, Jiangsu, China

RECRUITING

Caohu People's Hospital

Suzhou, Jiangsu, China

RECRUITING

...and 3 more locations

Outcomes

Primary Outcomes

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 Outcomes

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

Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community

Overview

Conditions

Interventions

Eligibility

Locations (13)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts