Evaluating the Effectiveness of a Smart Screening and Tiered Management Tool for Diabetic Kidney Disease in Primary Care: A Cluster Randomized Trial

NCT07707518 | Not Yet Recruiting DMC

• 2 other identifiers: 2024ZD0523305ZZ2024-567-02
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

This is a cluster-randomized controlled trial aiming to evaluate the effectiveness of an intelligent standardized screening and risk-stratified management tool for diabetic kidney disease (DKD) among adults with type 2 diabetes in primary care settings. Background China has a high prevalence of type 2 diabetes, and 30%-40% of diabetic patients develop DKD, the leading cause of end-stage kidney disease. Primary care facilities lack convenient, standardized digital tools to screen, grade and manage DKD systematically, leading to delayed detection and suboptimal kidney protection for diabetic patients. This study develops a localized intelligent DKD management system integrated into primary care electronic medical records (HIS) to solve this gap. Study Design \& Participants We will recruit 30 primary healthcare institutions (15 urban community health centers, 15 rural township health centers) across Longyou County, with at least 200 registered type 2 diabetes patients at each site. A total of 3,000 eligible adults aged 18-75 years diagnosed with type 2 diabetes will be enrolled, randomly assigned in a 1:1 cluster ratio to two groups: Intervention group (15 sites, 1,500 patients): Receive the intelligent DKD screening and graded management plug-in embedded in local HIS. The tool automatically calculates estimated glomerular filtration rate (eGFR), generates DKD risk stratification, sends reminders for regular urine albumin creatinine ratio (UACR) testing, and provides individualized treatment, follow-up and referral guidance. Control group (15 sites, 1,500 patients): Receive routine standard diabetes management following national primary care diabetes guidelines, without access to the intelligent DKD digital support system. Study Procedures All participants complete a baseline screening visit (V1) to sign informed consent, review medical history, complete physical examinations, and undergo lab tests including UACR, serum creatinine, fasting blood glucose, glycated hemoglobin, lipid profile and urinalysis. Follow-up visits are scheduled at 3 months (V2), 6 months (V3), and 12 months (V4) after baseline, repeating physical checks and core laboratory testing. An optional extended observational follow-up continues until 24 months, with biospecimens collected and shipped to the central research laboratory for unified testing. Participants may withdraw voluntarily at any time without impact on routine clinical care, and unscheduled visits will be arranged if adverse events or abnormal lab results occur. Key Study Outcomes Primary Outcome: Change in log-transformed urine albumin creatinine ratio (UACR) from baseline to the 12-month follow-up, comparing the two management models. Secondary Outcomes: 12-month DKD screening rate, DKD diagnosis rate, standardized DKD treatment rate, and change in eGFR over 12 months. The study also assesses the operability of the intelligent management tool and patient treatment adherence in primary care. Risks \& Benefits Potential Risks: Participants will undergo routine fasting blood draws and urine collection at each visit, which may cause minor temporary pain, bruising, or rare vasovagal reactions during venipuncture. Benefits: All participants receive free regular DKD-related laboratory testing covered by the research team. Intervention group patients receive personalized, automated kidney risk management recommendations to slow DKD progression. Any study-related injury will receive free medical treatment and corresponding compensation from the research project. Data Protection \& Ethics All participant personal information and biological samples are fully anonymized with unique study codes and stored in encrypted databases with restricted access. The study strictly complies with the Declaration of Helsinki, Chinese GCP, and domestic clinical research regulations. All participants provide written informed consent before enrollment, with full rights to withdraw at any stage without penalty. Study results will be published in peer-reviewed journals and presented at academic conferences to improve nationwide primary care DKD prevention and control. Statistical Analysis All analyses will use intention-to-treat, modified intention-to-treat, per-protocol, and safety analysis datasets. Mixed models for repeated measures, t-tests, rank-sum tests, and Fisher's exact tests will be applied to compare between-group differences, with multiple imputation used to handle missing primary endpoint data. All adverse events will be coded using MedDRA and summarized to evaluate the safety profile of the intervention strategy.

Conditions

Type 2 Diabetes Mellitus; Diabetic Kidney Disease

Keywords

Type 2 diabetes; Diabetic kidney disease; Primary care; CDSS; Cluster randomized trial

Outcome Measures

Primary Outcomes (1)

• Change in urinary albumin-to-creatinine ratio (UACR) from baseline to 1 year after intervention

  Compare the difference in the change of UACR levels between the DKD-CDSS intervention group and routine management group at 1 year of intervention. Spot urine specimens are tested by unified laboratory standards to quantify urinary albumin and creatinine, which reflects the degree of early renal damage in patients with type 2 diabetes mellitus.

  1 year after intervention initiation

Secondary Outcomes (4)

• DKD screening rate at 1 year after intervention

  1 year after intervention initiation

• DKD diagnosis rate at 1 year after intervention

  1 year after intervention initiation

• Standardized treatment rate of DKD at 1 year after intervention

  1 year after intervention initiation

• Change in estimated glomerular filtration rate (eGFR) from baseline to 1 year after intervention

  1 year after intervention initiation

Study Arms (2)

DKD Clinical Decision Support System Intervention Group

EXPERIMENTAL

The participating primary medical institutions in this group adopt the DKD standardized screening and intelligent graded management software embedded as a plug-in into the HIS system. The digital tool can automatically calculate eGFR, complete DKD risk stratification, send intelligent reminders for UACR screening, and provide individualized treatment targets, follow-up plans and referral prompts in line with relevant guidelines. All enrolled subjects receive unified physical examinations and laboratory tests at each scheduled visit according to the research protocol.

Behavioral: Intervention Name Clinical decision support system for diabetic kidney disease (DKD-CDSS)

Routine Conventional Diabetes Management Group

ACTIVE COMPARATOR

The participating primary medical institutions in this group carry out routine diabetes management in accordance with the National Primary Diabetes Prevention and Control Guidelines and national basic public health service requirements, without using the DKD intelligent screening and graded management tool developed in this study. There are no digital auxiliary functions such as automatic eGFR calculation, risk grading, intelligent follow-up and referral reminders during the whole management process. All enrolled subjects receive the same physical examination items and laboratory testing frequency as the intervention group.

Behavioral: Routine guideline-based diabetes management

Interventions

Intervention Name Clinical decision support system for diabetic kidney disease (DKD-CDSS) BEHAVIORAL

This study's intervention is a hospital information system-embedded diabetic kidney disease clinical decision support system (DKD-CDSS). It automatically computes eGFR, completes DKD risk stratification, triggers UACR screening reminders, and outputs individualized guideline-aligned glycemic, blood pressure, lipid control targets, medication adjustment suggestions, follow-up schedules and specialist referral advice for type 2 diabetes patients. Unlike general diabetes management software, this CDSS focuses specifically on early renal injury screening and hierarchical standardized treatment of DKD, and is tailored for primary care community and township medical institutions. The control arm only adopts traditional manual routine diabetes management without this dedicated DKD auxiliary decision-making module.

DKD Clinical Decision Support System Intervention Group

Routine guideline-based diabetes management BEHAVIORAL

Participants in this arm receive routine diabetes management in accordance with national primary diabetes prevention and control guidelines without access to the dedicated DKD clinical decision support system. Clinicians rely on their own clinical experience to judge DKD risk, arrange UACR screening, adjust hypoglycemic and hypotensive drugs, and formulate follow-up plans, without automatic system reminders or standardized hierarchical treatment recommendations targeting diabetic kidney disease. The inspection schedule and physical examination items are completely consistent with the intervention group, while all medical decision-making links do not get auxiliary prompts from the DKD-specific CDSS.

Routine Conventional Diabetes Management Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old.
• Diagnosed with type 2 diabetes mellitus.
• Able to complete follow-up visits and relevant examinations as required.
• Voluntary participation with signed informed consent.

You may not qualify if:

• Complicated with severe hepatic, renal, cardiac or malignant tumor diseases.
• With acute complications of diabetes or severe infectious diseases within 3 months.
• Pregnant or lactating women.
• Participating in other similar clinical intervention studies.
• Unable to cooperate with study management due to cognitive or mental disorders.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Chongqing

Chongqing, Chongqing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

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

Central Study Contacts

Zhihong Wang, Doctor of Philosophy

CONTACT

+86 13883021919; towzh713@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, no blinding was implemented at the level of primary healthcare institutions, but the personnel measuring the outcome indicators were blinded. After confirming that the institutions met the inclusion criteria, the researchers specifically responsible for the randomization of the project from the project's principal unit informed the participants of the group allocation and initiated the corresponding intervention measures.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a cluster parallel assignment design. Thirty primary care institutions (15 urban community health centers and 15 rural township health centers) are randomly allocated at a 1:1 ratio into two parallel groups. All eligible type 2 diabetes patients within each allocated institution receive the same group management mode throughout the trial without crossover or switching between arms. The intervention group uses an intelligent DKD screening and graded management HIS plug-in, while the control group receives standard routine diabetes management per national guidelines without the digital auxiliary tool. Individual participants are not independently randomized; randomization is conducted at the institutional level to avoid contamination of management strategies.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)