[Interpretation of treatment part of national guideline for the prevention and control of diabetes in primary care (2018)].
T W Gu, D L Zhu
https://pubmed.ncbi.nlm.nih.gov/31269573Actively Recruiting
Phase Not Applicable
Age: 65Years +
All Genders
ID05349955
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)
Led by Shanghai Zhongshan Hospital · Updated on 2025-05-14
5600
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the effects and safety of implementing a diabetic guideline algorithm by primary care physicians in a community setting. It focuses on elderly patients aged 65 and older with type 2 diabetes who have high or very high cardiovascular risk and complications such as chronic kidney disease or cardiovascular disease. The study aims to see if the guideline-based intervention can reduce major cardiovascular events and improve cardiovascular and renal outcomes over time. The trial is a cluster-randomized controlled study with two groups: one receiving intensive guideline algorithm implementation prioritizing drugs like SGLT2 inhibitors or GLP-1 receptor agonists for high-risk patients, targeting specific blood sugar, blood pressure, and cholesterol goals; and the other receiving conventional guideline-based care managed by local physicians with education support. The intervention targets include HbA1C under 7%, blood pressure below 130/80 mmHg, and LDL cholesterol below certain thresholds depending on risk level. The study duration is four years, with Phase 1 assessing control of risk factors at 18 months and Phase 2 evaluating cardiovascular and kidney outcomes at three years. Participants will undergo assessments to monitor blood sugar control, blood pressure, cholesterol levels, kidney function, cardiovascular events, and other health markers such as heart function, retinopathy, cognitive function, and frailty over the study period. Data collection includes measuring primary outcomes like combined cardiovascular events and hospitalization for heart failure, as well as secondary outcomes including changes in glycemic control, kidney disease progression, and body weight. Safety and adherence to treatment guidelines will be tracked throughout. The study involves regular follow-up to evaluate the impact of guideline implementation on health outcomes in elderly diabetics with high cardiovascular risk.
CONDITIONS
Brief Title
Effects and Safety of Diabetic GUideline Algorithm Implementation Performed by Primary Care Physicians in the Community
Who Can Participate
Age: 65Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Males or females aged 65 and above receiving treatment from local community health service centers
- Diagnosed with type 2 diabetes according to ADA criteria, confirmed by repeated blood sugar tests
- Have chronic kidney disease and/or very high or high cardiovascular risk, including a history of atherosclerotic cardiovascular disease, target organ damage, three or more major risk factors, or diabetes duration of 10 years or more with cardiovascular risk factors
You will not qualify if you...
- Pregnant women or women planning to become pregnant
- Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73m2
- Unable to be followed up for 36 months due to health or migration reasons
- Unwilling or unable to provide informed consent
- Diagnosed with type 1 diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 years
Participants receive guideline algorithm-based interventions implemented by primary care physicians to manage diabetes and cardiovascular risk factors, including prioritization of specific anti-diabetic drugs and comprehensive control of blood sugar, blood pressure, and lipids.
Regular visits scheduled by primary care physicians during treatment
Follow-up
Duration - Up to 1 year after treatment
Participants are monitored for cardiovascular and renal outcomes and safety after receiving the guideline algorithm intervention.
Visits as needed for outcome assessments up to 4 years total study duration
Trial Site Locations
Total: 13 locations
1
Xiangcheng Second People's Hospital
Suzhou, Jaingsu, China, 215501
Actively Recruiting
2
Caohu Community Healthcare Center
Suzhou, Jiangsu, China, 215006
Actively Recruiting
3
Huangqiao Community Healthcare Center
Suzhou, Jiangsu, China, 215006
Actively Recruiting
4
Xiangcheng People's Hospital.
Suzhou, Jiangsu, China, 215131
Actively Recruiting
5
Yuanhe Community Healthcare Center
Suzhou, Jiangsu, China, 215131
Actively Recruiting
6
Xiangcheng Third People's Hospital
Suzhou, Jiangsu, China, 215134
Actively Recruiting
7
Taiping Community Healthcare Center
Suzhou, Jiangsu, China, 215137
Actively Recruiting
8
Yangchenghu People's Hospital
Suzhou, Jiangsu, China, 215138
Actively Recruiting
9
Health Center of Xiangcheng Tourism Resort
Suzhou, Jiangsu, China, 215141
Actively Recruiting
10
Caohu People's Hospital
Suzhou, Jiangsu, China, 215144
Actively Recruiting
11
Dongqiao Community Healthcare Center
Suzhou, Jiangsu, China, 215152
Actively Recruiting
12
Xiangcheng Traditional Chinese Medicine Hospital
Suzhou, Jiangsu, China, 215155
Actively Recruiting
13
Chengyang Community Healthcare Center
Suzhou, Jiangsu, China
Actively Recruiting
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Research Team
X
Xiaoying Li, MD
X
Xiaomu Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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