Diabetes and its complication
Conditions
Interventions
Intervention Group:Digital therapy + conventional medical care
Control Group:Conventional medical care
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age: =18 2) Diagnosis of diabetes (ADA criteria): 1HbA1c =6.5%; or 2fasting blood glucose =7.0 mmol/L; or 32 - h PG =11.1 mmol/L; or 4random blood glucose =11.1 mmol/L in individuals with typical symptoms of hyperglycemia or hyperglycemic crisis 3) Ability to use a smartphone(Determined by digital therapy modality) 4) At least one of the following conditions: 1Uncontrolled diabetes: HbA1c =7% if under 65 years old or =7.5% if over 65 years old (if accompanied by complex health conditions (with significant cognitive and/or functional limitations, weakness, serious comorbidities), =7.5% if under 65 years old or =8% if over 65 years old)2Blood pressure =130/80 mm Hg, 3 LDL-cholesterol =2.6 mmol/L (=1.8 mmol/L if patients with =1 risk factor for atherosclerotic cardiovascular disease, =1.4 mmol/L if combined with atherosclerotic cardiovascular disease) 5) Patients signed the informed consent voluntarily and were able to complete follow-up and examinations as planned according to the protocol
Exclusion criteria
Exclusion criteria: 1) Breastfeeding or pregnant women, or women or men with recent reproductive plans 2) Life expectancy 1.5 times, ANC 3 times normal, or other blood system diseases (severe anemia, idiopathic thrombocytopenic purpura, splenomegaly, coagulation dysfunction, etc.) 7) Any medical conditions, abnormal examinations, or diseases that the researchers believe may increase the risk of the study participants 8) Unable to understand the potential risks and benefits of the study, incompetent for legal conduct
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean overall change in HbA1c, SBP and LDL-c levels;Proportion of patients with HbA1c, SBP and LDL-c achieving treatment goals;Proportion of patients with new chronic complications of diabetes;Proportion of patients requiring hospitalization due to diabetes complications;eGFR slope;adverse event;Incidence of intervention-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug compliance;Smoking status;drinking status;change of BMI;exercise status;Changes in health-related quality of life;Proportion of patients requiring hospitalization for cardiovascular reasons;The change of diabetic retinopathy grade;Changes in Visual Analog Scale;Incidence of foot ulcers or amputations; | — |
Countries
China
Contacts
Public ContactLiu Fang
West China hospital of Sichuan University
Outcome results
None listed