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Diabetes care management study focusing on standardized basal insulin treatment pathway

Diabetes care management quality improvement study focusing on basal insulin treatment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-15006935
Enrollment
Unknown
Registered
1990-01-01
Start date
2015-09-07
Completion date
Unknown
Last updated
2017-04-18

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

Type 2 diabetes mellitus:NA

Sponsors

Third Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Study centers: Endocrinology department in tier 2 and over tier 2 hospital Head of the department willing to improve the diabetes care management in the department through educational training and coaching Adopter of treatment pathway for diabetes management At least 60%outpatient endocrinologists will attend the iterative education program Patients: Outpatient with type 2 diabetes mellitus (T2DM) Man or woman aged =18 years Using basal insulin either in monotherapy or in combination with oral antidiabetic drugs (OADs) for =3 months Followed up in the study site for =3months before enrollment Hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) tests performed at the site within 1 month before patient enrollment Signed informed consent obtained prior to any study procedure

Exclusion criteria

Exclusion criteria: Patients: Diabetes other than T2DM (e.g. type 1 diabetes mellitus, diabetes secondary to pancreatic disorders, drug or chemical agent intake)

Design outcomes

Primary

MeasureTime frame
The percentage of hospitals successful in basal insulin quality improvement;hospital achieving the individualized quality improvement goal preset by Study Committees;

Secondary

MeasureTime frame
The percentage of patients achieving the glucose goal (HbA1c <7%) at baseline and the end of Month 6;The average HbA1c at baseline and the end of Month 6;The average FPG at baseline and the end of Month 6;The percentage of patients achieving the FPG goal (FPG <6.1 mmol/L) at baseline and the end of Month 6;The rate of hypoglycemia events at baseline and the end of Month 6;The rate of severe hypoglycemia events at baseline and the end of Month 6;The patients quality of life assessed by EuroQoL-5Dimensions (EQ-5D) at baseline and the end of Month 6;The investigators confidence in basal insulin assessment by questionnaire at baseline and the end of Month 6;The investigators daily practice in basal insulin assessment by questionnaire at baseline and the end of Month;

Countries

China

Contacts

Public ContactZHANG Tong
tong3.zhang@sanofi.com+86 10 65634801

Outcome results

None listed

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