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Long-term efficacy evaluation of integrated management of type 2 diabetes mellitus with obstructive sleep apnea syndrome

Long-term efficacy evaluation of integrated management of type 2 diabetes mellitus with obstructive sleep apnea syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102078
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-05-15
Completion date
Unknown
Last updated
2025-05-12

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

Conditions

Diabetes, Obstructive sleep apnea

Interventions

Outpatient group:Patients who are positive for OSAS questionnaire screening and who are positive for home sleep monitoring (HST) are encouraged to go to an OSAS specialist or tertiary hospital for dia
Control group:Patients who tested positive for OSAS were mobilized to go to OSAS specialist or tertiary hospitals for OSAS diagnosis and treatment
Integrated management group:Patients who were positive for OSAS questionnaire screening and who were positive for sleep monitoring at home (HST) were treated with remote diagnosis, CPAP treatment and

Sponsors

Institute for Chronic Non-communicable Disease Control and Prevention, Hangzhou Center for Disease Control and Prevention (Hangzhou Health Supervision Institution)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 69 Years

Inclusion criteria

Inclusion criteria: (1) Age 25-69 years old; (2) Overweight or obesity (body mass index BMI is 25Kg/m^2); (3) PRIOR DIAGNOSIS OF TYPE 2 DIABETES MELLITUS, DEFINED AS: [I] CURRENT ORAL ANTIDIABETIC MEDICATIONS AND/OR INSULIN; or [II] at least 2 fasting blood glucose levels >126mg/dL; or [III] 2 hours later, oral glucose tolerance test: blood glucose level>=200mg/dL; or [IV.] glycosylated hemoglobin (HbA1c) >6.5%; (4) The diabetes medication was stable in the past 4 weeks, and the healthy lifestyle behavior did not change greatly; (5) Resident at the selected study site (selected street/township) and belong to the diabetes patient under management; (6) Can access the Internet and make and receive calls, fluent in Chinese; (7) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Have any kind of diabetic complications (nephropathy, neuropathy, retinopathy, diabetic foot); (2) severe daytime sleepiness (Epworth sleep score >18); (3) Acute coronary syndrome, stroke, transient ischemic attack, or hospitalization due to worsening heart failure within the previous 30 days; (4) other types of diabetes other than type 2 diabetes; (5) Systolic blood pressure >= 180mmHg or diastolic blood pressure >= 110mmHg; (6) continuous treatment with non-steroidal anti-inflammatory drugs, or regular use of sleep-improving psychotropic drugs; (7) Prior CPAP therapy; (8) Known renal insufficiency, creatinine concentration greater than 1.5mg/dl; (9) Patients engaged in hazardous occupations or work involving dangerous goods; (10) Women of childbearing potential who are pregnant or do not have contraception.

Design outcomes

Primary

MeasureTime frame
HbA1c;Homeostatic Model Assessment of Insulin Resistance;Usage of hypoglycemic agents;

Secondary

MeasureTime frame
Functional Outcomes of Sleep Questionnaire - 10, FOSQ-10;Diagnosis rate of OSAS;Treatment rate of OSAS ;The average daily usage time of CPAP (Continuous Positive Airway Pressure) device;

Countries

China

Contacts

Public ContactJue Xu

Hangzhou Center for Disease Control and Prevention (Hangzhou Health Supervision Institution)

xu.jue@outlook.com+86 571 8515 2724

Outcome results

None listed

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