Clinical trial NCT00288678: A Prospective Study on Diabetes Management Through an Integrated Delivery System
Official title: A Prospective Study on Diabetes Management Through an Integrated Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Diabetic shared care
Health manager
Prospective Study
Health Care Quality, Access, and Evaluation
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
First posted: 2006-02-08
Enrollment: 1222
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 1. To demonstrate a feasible hospital-based diabetic shared care model in Taiwan.
2. To compare effectiveness of diabetes control between patients receiving case management provided by a health manager and patients receiving usual care.
3. To determine the optimal level of glucose, blood pressure and lipids in control of diabetes in Taiwan.

Detailed description: Five general hospitals, including both public and private, are chosen as regional coordinating centers in this project. Collaborating with community physicians, project coordinating-centers randomize diabetic patients, who have signed informed consent, into either intervention or control group. While two annual comprehensive lab tests are offered to the control group, an additional package of consultations and coordinating services provided by health managers is appended to the intervention group. Qualified health managers are cultivated in five selected medical institutes to support primary care physicians in managing diabetic patients. Responsibilities of health managers include tracking and updating enrolled patients' information, providing adequate and scheduled consultations, arranging specialty referrals for patients in needs, and transferring stable patients back to their original physicians. The feasibility phase of the project implementation will last for three years and it will be followed by a phase of full-scale implementation for another two years. Glycemic control as well as health status of participants will be the indicators to evaluate outcome of the project. At the same time, the periodic measurements on glucose, blood pressures, lipids and the incidence of complications will also be analyzed to set up an optimal target for diabetic control in Taiwan.

Eligibility criteria: Inclusion Criteria:

1. Symptoms of diabetes plus casual plasma glucose concentration 200 mg/dl (11.1 mmol/l). Casual is defined as any time of day without regard to time since last meal. The classic symptoms of diabetes include polyuria, polydipsia, and unexplained weight loss.
2. Fasting plasma glucose 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 hours.

3.2-hour plasma glucose 200 mg/dl (11.1 mmol/l) during an oral glucose tolerance test (OGTT). The test should be performed using a glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water.

Exclusion Criteria:

1. Type 1 diabetes (Insulin dependent diabetes, IDDM)
2. Women who are pregnant at the entry time.
3. Those who have history of myocardial infraction (MI), cerebrovascular accident (CVA), foot amputation and uremia under dialysis.

Primary outcomes:
measure: Through the health manager's coordination and consultation, diabetic patients will have better glycemic control for fasting plasma glucose, HbA1c, and blood cholesterol level.
Secondary outcomes:
measure: Patients in the intervention group will have better health status such as lower hospitalization rate, shorter length of stay in hospitals, and fewer diabetic complications.
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Tri-Services General Hospital
city: Taoyuan
country: Taiwan
facility: Min-Shen General Hospital
Study officials:
affiliation: National Health Research Instiutes
name: Chih-Cheng Hsu, M.D, Dr. P.H
role: PRINCIPAL_INVESTIGATOR
affiliation: National Health Research Instiutes
name: Hsing-Yi Chang, Ph. Dr. P.H
role: PRINCIPAL_INVESTIGATOR
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