Clinical trial NCT05349955: Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community
Official title: Effects and Safety of GUideline Algorithm Based Intervention on CaRdiovascular and Renal Outcomes in Elderly Diabetic Patients With High Cardiovascular Risk in the Community- A Cluster Randomized Controlled Trial (GUARD-Community Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Cardiovascular Complication
Diabetic Kidney Disease
Keywords: Diabetes implementation study
Diabetes guideline algorithm
Cardiovascular disease
Chronic kidney disease
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 5600
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Guideline based comprehensive management on the diabetic patients. In brief, SGLT2i or GLP-1RA will be used in priority in elderly diabetic patients with very high/high CV risk, and blood pressure controlled under 130/80mmHg， LDL-c\<1.8mmol/L in the very high-risk patients or \<2.6mmol/L in the high risk patients according to ESC/EASD guidelines.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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;

Primary outcomes:
measure: 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.
timeFrame: 18 months since randomization
measure: Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure.
timeFrame: 3 years since randomization
Secondary outcomes:
measure: Secondary Outcome of Phase 1: Glycemic control rate
timeFrame: 18 months since randomization
measure: Secondary Outcome of Phase 1: Mean HbA1C changes
timeFrame: 18 months since randomization
measure: Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes
timeFrame: 18 months since randomization
measure: Secondary Outcome of Phase 1: Mean LDL-c changes
timeFrame: 18 months since randomization
measure: Secondary Outcome of Phase 1: Adherence to guideline algorithm medication recommendation rate
timeFrame: 18 months since randomization
measure: Secondary Outcome of Phase 2: Incident or worsening nephropathy
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Cardiorenal composite endpoint
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: 3P MACE
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: New onset of macroalbuminuria.
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Changes of myocardial ischemia in electrocardiogram (ECG)
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: New onset of albuminuria
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Albuminuria progression
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Albuminuria regression
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Changes in the ratio of patients with normal or abnormal urine protein at the end of the study
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Slope of eGFR decline
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Retinopathy changes
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Body weight change
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Changes of fatty liver prevalence
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Changes in beta-cell function
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: Changes in cognitive function
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: The FRAIL scale
timeFrame: 3 years since randomization
measure: Secondary Outcome of Phase 2: All-cause death
timeFrame: 3 years since randomization
Other outcomes:
measure: Health Economics Indicators
timeFrame: 3 years since randomization
measure: Changes in cardiovascular risk indicators
timeFrame: 3 years since randomization
measure: Serology and urine testing
timeFrame: 3 years since randomization
measure: Genomics testing
timeFrame: 3 years since randomization
measure: The time rate of glycemic target range
timeFrame: 3 years since randomization
Locations:
city: Suzhou
country: China
facility: Xiangcheng Second People's Hospital
state: Jaingsu
city: Suzhou
country: China
facility: Caohu Community Healthcare Center
state: Jiangsu
city: Suzhou
country: China
facility: Huangqiao Community Healthcare Center
state: Jiangsu
city: Suzhou
country: China
facility: Xiangcheng People's Hospital.
state: Jiangsu
city: Suzhou
country: China
facility: Yuanhe Community Healthcare Center
state: Jiangsu
city: Suzhou
country: China
facility: Xiangcheng Third People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Taiping Community Healthcare Center
state: Jiangsu
city: Suzhou
country: China
facility: Yangchenghu People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Health Center of Xiangcheng Tourism Resort
state: Jiangsu
city: Suzhou
country: China
facility: Caohu People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Dongqiao Community Healthcare Center
state: Jiangsu
city: Suzhou
country: China
facility: Xiangcheng Traditional Chinese Medicine Hospital
state: Jiangsu
city: Suzhou
country: China
facility: Chengyang Community Healthcare Center
state: Jiangsu
Study officials:
affiliation: Fudan University
name: Xiaoying Li, MD
role: PRINCIPAL_INVESTIGATOR
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