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

NCT05349955 | Recruiting

• 1 other identifier: ZSE 20220401
• Study Type: interventional
• Target: 5,600
• Locations: 1 country
• Sites: 13

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.

Conditions

Type 2 Diabetes; Cardiovascular Complication; Diabetic Kidney Disease

Keywords

Diabetes implementation study; Diabetes guideline algorithm; Cardiovascular disease; Chronic kidney disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  3 years since randomization

Secondary Outcomes (22)

• Secondary Outcome of Phase 1: Glycemic control rate

  18 months since randomization

• Secondary Outcome of Phase 1: Mean HbA1C changes

  18 months since randomization

• Secondary Outcome of Phase 1: Mean systolic and diastolic pressure changes

  18 months since randomization

• Secondary Outcome of Phase 1: Mean LDL-c changes

  18 months since randomization

• Secondary Outcome of Phase 1: Adherence to guideline algorithm medication recommendation rate

  18 months since randomization

Other Outcomes (5)

• Health Economics Indicators

  3 years since randomization

• Changes in cardiovascular risk indicators

  3 years since randomization

• Serology and urine testing

  3 years since randomization

Study Arms (2)

Intensive guideline algorithm implementation

EXPERIMENTAL

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

Conventional guideline algorithm implementation

ACTIVE COMPARATOR

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

Interventions

Intensive guideline algorithm implementation OTHER

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.

Intensive guideline algorithm implementation

Conventional guideline algorithm implementation OTHER

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.

Conventional guideline algorithm implementation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (13)

Xiangcheng Second People's Hospital

Suzhou, Jaingsu, 215501, China

RECRUITING

Caohu Community Healthcare Center

Suzhou, Jiangsu, 215006, China

RECRUITING

Huangqiao Community Healthcare Center

Suzhou, Jiangsu, 215006, China

RECRUITING

Xiangcheng People's Hospital.

Suzhou, Jiangsu, 215131, China

RECRUITING

Yuanhe Community Healthcare Center

Suzhou, Jiangsu, 215131, China

RECRUITING

Xiangcheng Third People's Hospital

Suzhou, Jiangsu, 215134, China

RECRUITING

Taiping Community Healthcare Center

Suzhou, Jiangsu, 215137, China

RECRUITING

Yangchenghu People's Hospital

Suzhou, Jiangsu, 215138, China

RECRUITING

Health Center of Xiangcheng Tourism Resort

Suzhou, Jiangsu, 215141, China

RECRUITING

Caohu People's Hospital

Suzhou, Jiangsu, 215144, China

RECRUITING

Dongqiao Community Healthcare Center

Suzhou, Jiangsu, 215152, China

RECRUITING

Xiangcheng Traditional Chinese Medicine Hospital

Suzhou, Jiangsu, 215155, China

RECRUITING

Chengyang Community Healthcare Center

Suzhou, Jiangsu, China

RECRUITING

Related Publications (16)

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  PMID: 33200892 BACKGROUND

• Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.

  PMID: 32970396 BACKGROUND

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  PMID: 30990260 BACKGROUND

• Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

  PMID: 27295427 BACKGROUND

• Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.

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  PMID: 33298420 BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies; Cardiovascular Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaoying Li, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoying Li, MD

CONTACT

13651913857; li.xiaoying@zs-hospital.sh.cn

Xiaomu Li, MD

CONTACT

13661676591; li.xiaomu@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessment Committee members will be blinded to outcome assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Endocrinology Department

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 27, 2022
• Study Start: November 21, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)