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Effects of remote management based on behavioral economics theory on patients with type 2 diabetes mellitus

Effects of remote management based on behavioral economics theory on patients with type 2 diabetes mellitus

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070753
Enrollment
Unknown
Registered
2023-04-22
Start date
2023-04-15
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

type 2 diabetes

Interventions

A group:Remote management+ incentive 1 + usual care
B group:Remote management+incentive 2+ usual care
C group:usual care

Sponsors

Kunshan First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 at the time of signing the informed consent; 2. Diagnosed with type 2 diabetes mellitus (> 6 months) according to WHO criteria in 1999; 3. Stable treatment of diabetes =2 months, and HbA1c test result of 7.0%=HbA1c=10.5%; 4. Barrier-free use of smart phones, basic Chinese reading and writing ability, simple computing ability; 5. The subjects sign the informed consent voluntarily and agree to strictly follow the requirements of this program.

Exclusion criteria

Exclusion criteria: 1. Chinese patent medicine or Chinese herbal medicine with hypoglycemic effect should be used within 2 months before screening; 2. Receiving chronic (> 2 weeks) systemic glucocorticoid therapy, or having used glucocorticoids within 4 weeks prior to screening (except for topical, intraocular, intranasal, or inhalation administration); 3. Two or more cases of ketosis, diabetic hypertonic state, or lactic acidosis in the 6 months prior to screening; 4. Patients with a history of severe hypoglycemia within 6 months prior to screening, defined as neurohypoglycemia symptoms and requiring treatment to recover, or who were completely unaware of hypoglycemia or had insufficient recognition of hypoglycemia symptoms, and who were considered by the investigator to be unable to communicate and understand hypoglycemia symptoms and appropriate treatment, should also be excluded from the study; 5.2 Type 2 diabetes mellitus with severe chronic complications, such as diabetic foot; 6. History of acute or chronic pancreatitis; 7. The presence of proliferative diabetic retinopathy, or diabetic macular edema, or non-proliferative diabetic retinopathy requiring emergency treatment in the past or at the time of screening; 8. It was diagnosed as autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension or diabetic diarrhea; 9. Patients with acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, percutaneous coronary intervention (other than diagnostic angiography), TIA, cerebrovascular accident, decompensated heart failure, or NYHA stage III or ? heart failure in the 6 months prior to screening; 10. Acute non-cardiogenic diseases, such as infection, renal failure, hyperthyroidism, etc.; 11. Complicated with other serious cardiovascular diseases: moderate to severe stenosis valvular heart disease, hypertrophic cardiomyopathy or other forms of outflow tract stenosis, acute myocarditis, pericarditis, active endocarditis, suspected or known aneurysm rupture, acute pulmonary embolism or pulmonary infarction; 12. Neurological, muscular, skeletal and rheumatic diseases that may be aggravated by other sports; 13. Mental illness in which the patient is unable to live independently or cooperate with treatment; 14. Breastfeeding, pregnancy or pregnancy planning; 15. Patients deemed unsuitable for study inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
The differences in Hba1c results among the three groups were compared;

Secondary

MeasureTime frame
The difference of SMBG detection rate among the three groups was compared;The differences in body weight were compared among the three groups;The differences in diabetes self-efficacy among the three groups were compared;

Countries

China

Contacts

Public ContactZhong Shao

Kunshan First People's Hospital

drzhong@163.com+86 13328056828

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026