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

Primary Purpose

Type 2 Diabetes, Cardiovascular Complication, Diabetic Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intensive guideline algorithm implementation
Conventional guideline algorithm implementation
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes implementation study, Diabetes guideline algorithm, Cardiovascular disease, Chronic kidney disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Xiangcheng Second People's HospitalRecruiting
  • Caohu Community Healthcare Center
  • Huangqiao Community Healthcare Center
  • Xiangcheng People's Hospital.Recruiting
  • Yuanhe Community Healthcare CenterRecruiting
  • Xiangcheng Third People's HospitalRecruiting
  • Taiping Community Healthcare CenterRecruiting
  • Yangchenghu People's Hospital
  • Health Center of Xiangcheng Tourism Resort
  • Caohu People's Hospital
  • Dongqiao Community Healthcare CenterRecruiting
  • Xiangcheng Traditional Chinese Medicine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive guideline algorithm implementation

Conventional guideline algorithm implementation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Secondary Outcome of Phase 1: Glycemic control rate
The proportion of participants with tight glucose control, targeting HbA1c <7.0%
Secondary Outcome of Phase 1: Mean HbA1C changes
Mean HbA1C changes of participants
Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes
Mean systolic and diastolic pressure changes of participants
Secondary Outcome of Phase 1: Mean LDL-c changes
Mean LDL-c changes of participants
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
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.
Secondary Outcome of Phase 2: Cardiorenal composite endpoint
Time to eGFR (CKD-EPI formula) decrease, renal replacement therapy, renal or cardiovascular death
Secondary Outcome of Phase 2: 3P MACE
Time to events occurence: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke
Secondary Outcome of Phase 2: New onset of macroalbuminuria.
Time to UACR>300mg/g
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.
Secondary Outcome of Phase 2: New onset of albuminuria
Time to UACR increase from <30mg/g to ≥30mg/g
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)
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%
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
Secondary Outcome of Phase 2: Slope of eGFR decline
Decrease of the eGFR over time
Secondary Outcome of Phase 2: Retinopathy changes
Occurrence or regression of retinopathy(ETDRS-DRSS)
Secondary Outcome of Phase 2: Body weight change
Absolute weight change and the percentage change of body weight
Secondary Outcome of Phase 2: Changes of fatty liver prevalence
Rate change of fatty liver.
Secondary Outcome of Phase 2: Changes in beta-cell function
Absolute change assessed by HOMA2-%β method
Secondary Outcome of Phase 2: Changes in cognitive function
Improvement or progression of cognitive function: The Mini-CogTM scale
Secondary Outcome of Phase 2: The FRAIL scale
Changes of the simple frailty questionnaire score
Secondary Outcome of Phase 2: All-cause death
Time to the death due to any cause

Full Information

First Posted
April 16, 2022
Last Updated
June 28, 2023
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05349955
Brief Title
Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community
Acronym
GUARD
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
November 30, 2026 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Cardiovascular Complication, Diabetic Kidney Disease
Keywords
Diabetes implementation study, Diabetes guideline algorithm, Cardiovascular disease, Chronic kidney disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Outcome Assessment Committee members will be blinded to outcome assignment.
Allocation
Randomized
Enrollment
5600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intensive guideline algorithm implementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional guideline algorithm implementation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intensive guideline algorithm implementation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional guideline algorithm implementation
Intervention Description
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 Measure Information:
Title
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.
Description
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
Title
Primary Outcome of Phase 2: Composite of 3P MACE and hospitalization for heart failure.
Description
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 Measure Information:
Title
Secondary Outcome of Phase 1: Glycemic control rate
Description
The proportion of participants with tight glucose control, targeting HbA1c <7.0%
Time Frame
18 months since randomization
Title
Secondary Outcome of Phase 1: Mean HbA1C changes
Description
Mean HbA1C changes of participants
Time Frame
18 months since randomization
Title
Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes
Description
Mean systolic and diastolic pressure changes of participants
Time Frame
18 months since randomization
Title
Secondary Outcome of Phase 1: Mean LDL-c changes
Description
Mean LDL-c changes of participants
Time Frame
18 months since randomization
Title
Secondary Outcome of Phase 1: Adherence to guideline algorithm medication recommendation rate
Description
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
Title
Secondary Outcome of Phase 2: Incident or worsening nephropathy
Description
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
Title
Secondary Outcome of Phase 2: Cardiorenal composite endpoint
Description
Time to eGFR (CKD-EPI formula) decrease, renal replacement therapy, renal or cardiovascular death
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: 3P MACE
Description
Time to events occurence: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: New onset of macroalbuminuria.
Description
Time to UACR>300mg/g
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: Changes of myocardial ischemia in electrocardiogram (ECG)
Description
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
Title
Secondary Outcome of Phase 2: New onset of albuminuria
Description
Time to UACR increase from <30mg/g to ≥30mg/g
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: Albuminuria progression
Description
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
Title
Secondary Outcome of Phase 2: Albuminuria regression
Description
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
Title
Secondary Outcome of Phase 2: Changes in the ratio of patients with normal or abnormal urine protein at the end of the study
Description
Rate change of normal or abnormal UACR. Normal means UACR<30mg/g. Abnormal means UACR≥30mg/g
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: Slope of eGFR decline
Description
Decrease of the eGFR over time
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: Retinopathy changes
Description
Occurrence or regression of retinopathy(ETDRS-DRSS)
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: Body weight change
Description
Absolute weight change and the percentage change of body weight
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: Changes of fatty liver prevalence
Description
Rate change of fatty liver.
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: Changes in beta-cell function
Description
Absolute change assessed by HOMA2-%β method
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: Changes in cognitive function
Description
Improvement or progression of cognitive function: The Mini-CogTM scale
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: The FRAIL scale
Description
Changes of the simple frailty questionnaire score
Time Frame
3 years since randomization
Title
Secondary Outcome of Phase 2: All-cause death
Description
Time to the death due to any cause
Time Frame
3 years since randomization
Other Pre-specified Outcome Measures:
Title
Health Economics Indicators
Description
Cost-effectiveness analysis： quantification of Incremental Cost Ratio Life Cycle (ICER) and Quality Adjusted Years (QALYs)
Time Frame
3 years since randomization
Title
Changes in cardiovascular risk indicators
Description
Framingham score
Time Frame
3 years since randomization
Title
Serology and urine testing
Description
Biomarkers associated with diagnosis or prognosis: using "omics" screening.
Time Frame
3 years since randomization
Title
Genomics testing
Description
Gene polymorphism testing for drug response or prognosis: using genome-wide association study(GWAS) screening.
Time Frame
3 years since randomization
Title
The time rate of glycemic target range
Description
Continous glucose monitor detection
Time Frame
3 years since randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoying Li, MD
Phone
13651913857
Email
li.xiaoying@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaomu Li, MD
Phone
13661676591
Email
li.xiaomu@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoying Li, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xiangcheng Second People's Hospital
City
Suzhou
State/Province
Jaingsu
ZIP/Postal Code
215501
Country
China
Individual Site Status
Recruiting
Facility Name
Caohu Community Healthcare Center
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Huangqiao Community Healthcare Center
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Xiangcheng People's Hospital.
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215131
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuefei Xu, Bachelor
Phone
18818211531
Email
pyu15@fudan.edu.cn
Facility Name
Yuanhe Community Healthcare Center
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215131
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangcheng Third People's Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215134
Country
China
Individual Site Status
Recruiting
Facility Name
Taiping Community Healthcare Center
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215137
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuejian Ni, Bachelor
Email
2314831056@qq.com
Facility Name
Yangchenghu People's Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215138
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Health Center of Xiangcheng Tourism Resort
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215141
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Caohu People's Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215144
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Dongqiao Community Healthcare Center
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215152
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangcheng Traditional Chinese Medicine Hospital
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215155
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jichao Yu, Bachelor
Email
344314300@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be available from the principle investigator on reasonable request.
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Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community

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