A Prospective Study on Diabetes Management Through an Integrated Delivery System

Diabetes Mellitus Clinical Trial

— DMIDS  

Official title:

A Prospective Study on Diabetes Management Through an Integrated Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288678
• Other study ID #: HP-PP08
• Status: Completed
• Phase: Phase 3
• First received: February 7, 2006
• Last updated: January 26, 2010
• Start date: July 2003
• Est. completion date: December 2007

Study information

• Verified date: February 2008
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1222
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Procedure:
• Health Education

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Tri-Services General Hospital	Taipei
Taiwan	Min-Shen General Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (11)

American Diabetes Association. Screening for type 2 diabetes. Diabetes Care. 2000 Jan;23 Suppl 1:S20-3. — View Citation

American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002 Jan;25(1):213-29. — View Citation

Chicoye L, Roethel CR, Hatch MH, Wesolowski W. Diabetes care management: a managed care approach. WMJ. 1998 Mar;97(3):32-4. Review. — View Citation

Chiou ST, Lin HD, Yu NC, Hseuh HK, Lin LH, Lin LT, Chen TJ, Lai MS. An initial assessment of the feasibility and effectiveness of implementing diabetes shared care system in Taiwan--some experiences from I-Lan County. Diabetes Res Clin Pract. 2001 Nov;54 Suppl 1:S67-73. — View Citation

Chuang LM, Tsai ST, Huang BY, Tai TY; DIABCARE (Taiwan) Study Group. The current state of diabetes management in Taiwan. Diabetes Res Clin Pract. 2001 Nov;54 Suppl 1:S55-65. — View Citation

Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2000 Jan;23 Suppl 1:S4-19. — View Citation

Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD. Prevalence of diabetes, impaired fasting glucose, and impaired glucose tolerance in U.S. adults. The Third National Health and Nutrition Examination Survey, 1988-1994. Diabetes Care. 1998 Apr;21(4):518-24. — View Citation

Lin T, Chou P, Lai MS, Tsai ST, Tai TY. Direct costs-of-illness of patients with diabetes mellitus in Taiwan. Diabetes Res Clin Pract. 2001 Nov;54 Suppl 1:S43-6. — View Citation

Marshall CL, Bluestein M, Briere E, Chapin C, Darling B, Davis K, Davis T, Gersten J, Harris C, Hodgin A, Larsen W, Mabb D, Rigberg H, Watson D, Krishnaswami V. Improving outpatient diabetes management through a collaboration of six competing, capitated Medicare managed care plans. Am J Med Qual. 2000 Mar-Apr;15(2):65-71. — View Citation

Mensing C, Boucher J, Cypress M, Weinger K, Mulcahy K, Barta P, Hosey G, Kopher W, Lasichak A, Lamb B, Mangan M, Norman J, Tanja J, Yauk L, Wisdom K, Adams C. National standards for diabetes self-management education. Task Force to Review and Revise the National Standards for Diabetes Self-Management Education Programs. Diabetes Care. 2000 May;23(5):682-9. — View Citation

Rubin RJ, Dietrich KA, Hawk AD. Clinical and economic impact of implementing a comprehensive diabetes management program in managed care. J Clin Endocrinol Metab. 1998 Aug;83(8):2635-42. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

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