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'in-person Remote' Holonomic Diabetes Self-Management Support model: a multicenter, real-world cohort study with long-term follow-up

'in-person Remote' Holonomic Diabetes Self-Management Support model: a multicenter, real-world cohort study with long-term follow-up

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069177
Enrollment
Unknown
Registered
2023-03-08
Start date
2023-03-13
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Interventions

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes patients, aged 18-80 years (inclusive), who can continue to see doctors regularly (= 3 times a year); 2. Sign the informed consent voluntarily; 3. Patients who can cooperate with the'in-person Remote' Holonomic Diabetes Self-Management Support model management;

Exclusion criteria

Exclusion criteria: 1. Failure of important organs or other serious diseases, including patients with myocardial infarction, severe mental disorder, severe infection or disseminated intravascular coagulation within 12 months before enrollment; 2. Patients with active or inactive malignant tumors with life expectancy less than 1 year; 3. Patients who have communication barriers and cannot fully understand or cooperate; 4. Patients who have received remote management from other APPs.

Design outcomes

Primary

MeasureTime frame
MACE incidence of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction, revascularization, heart failure and nonfatal stroke);

Secondary

MeasureTime frame
Annual changes from baseline HbA1c and its in target rate;Annual changes from baseline BP and its in target rate;Annual changes from baseline LDL-c and its in target rate;Annual changes from baseline BMI and its in target rate;Annual change from the baseline on self-management behavior scale score;Annual change from baseline on self-efficacy scale score;Annual change from baseline on A-DQOL score;Annual changes in Morisky medication compliance score scale compared with the baseline;Annual change from baseline on DASS-21 score;Patient satisfaction score;Incidence of new onset diabetes nephropathy;Incidence of retinopathy in newly diagnosed diabetes;Incidence of new onset diabetes neuropathy;Incidence of new onset diabetes related lower extremity arterial disease;Incidence of newly diagnosed diabetes foot;Progression of albuminuria;Progression of diabetes retinopathy;Progression of lower extremity arterial disease in diabetes;Progression of diabetes foot;Incidence of hospitalization due to major infections/acute complications;Incidence of malignant tumors;Incidence rate of all-cause death;Long term cost-effectiveness of 'in-person Remote' Holonomic Diabetes Self-Management Support model;HbA1c in target rate (<7%);BP in target rate(<130/80 mmHg);LDL-c in target rate(<2.6 mmol/L);

Countries

China

Contacts

Public ContactZhang Junqing and Li Ang

Peking University First Hospital

liang850513@hotmail.com+86 13681338795

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026