Diabetic microvascular complications
Conditions
Interventions
Intervention group:These standardized diabetes complication screening workstations will facilitate scientific prevention and management of diabetes complications
Control group:Routine management and treatment for diabetes s will be conducted according to the requirements outlined by the National Essential Public Health Services
Sponsors
Zhongda Hospital, Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria for Grassroots Level and Community Health Organizations: (1) The health center has or is willing to establish a standardized diabetic microvascular complications screening workstation; (2) The health center must have at least one licensed physician qualified in diabetes management and diabetic complications management and one nurse trained in diabetic microvascular complication screening techniques; (3) The health center must use the centralized research platform provided by this study to complete the electronic Case Report Form (eCRF) data collection, participants screening, exclusion/inclusion evaluation, and clinical research tasks such as management of research interferences; (4) The health center must have a Traditional Chinese Medicine (TCM) clinic with at least one licensed TCM physician with 3+ years of experience in diabetes treatment; (5) The health center manages at least 100 registered diabetic patients; (6) Villages/communities included in the study must be at least 2 kilometers apart from each other. 2. Inclusion Criteria for Participants: (1) Participant is aged 18–75 and diagnosed with diabetes (with or without a diagnosis for microvascular complications). Diabetes diagnosis should align with the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition) or the Chinese Guidelines for the Diagnosis and Treatment of Type 1 Diabetes (2021 Edition); (2) Participant has good compliance and is willing to cooperate with screening protocols; (3) Participant voluntarily signs an informed consent form and commits to necessary follow-up appointments within a 3-year period.
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for Grassroots Level and Community Health Centers and Participating Villages: (1) The health center administers fewer than 4 subdistricts or villages; (2) Screening for diabetic microvascular complications has already been widely implemented in the area; the number of individuals who have not undergone screening is fewer than 100. 2. Exclusion Criteria for Participants: (1) Participants with severe cardiovascular/cerebrovascular conditions or abnormal hepatic/renal function (severe hepatic dysfunction: total bilirubin >2.5×upper limit of normal, any AST elevation; severe renal dysfunction: GFR <30 mL/min/1.73 m^2); (2) Participants with severe mental disorders or cognitive impairment that may prevent compliance with follow-ups (including dementia, etc.); (3) Participants with other severe end-stage diseases or an expected survival of less than 12 months; (4) Participants who have participated in other interventional clinical trials for diabetic microvascular complications within the past 3 months; (5) Participants with gestational diabetes or diabetes during lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of clinical events of microvascular complications in diabetes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetic retinopathy surgery rate;New-onset blindness rate;End-stage renal disease incidence rate;Amputation rate;Comprehensive metabolic control rate of diabetes (blood glucose, blood pressure, lipids, and body weight);Improvement in diabetes symptoms, comorbidity control rate, myocardial infarction, heart failure, cardiovascular-related mortality, stroke incidence rate, incidence of severe lower extremity arterial stenosis or occlusion, standardized diabetes management rate;Outpatient consultation fee, nursing fee, examination fee, laboratory test fee, treatment fee, medication fee (for surgeries: surgical anesthesia fee, bed fee and accompanying bed fee, material costs, etc.);Transportation costs, lost wages, and loss of labor capacity due to microvascular complications (such as inability to work from kidney failure or mental health issues caused by the condition);Household caregiving costs (e.g., long-term care required for patients with blindness or amputations); | — |
Countries
China
Contacts
Public ContactZilin Sun
Zhongda Hospital, Southeast University
Outcome results
None listed