A Prospective Study on Diabetes Management Through an Integrated Delivery System

NCT00288678 | Completed Phase 3

• 1 other identifier: HP-PP08
• Study Type: interventional
• Target: 1,222
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Diabetes Mellitus

Keywords

Diabetic shared care; Health manager; Prospective Study; Health Care Quality, Access, and Evaluation

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• 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.

Interventions

Health Education PROCEDURE

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Fasting plasma glucose 126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 hours.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (5)

Kaohsiung Medical University Hospital

Kaohsiung City, 80708, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

Tri-Services General Hospital

Taipei, 11490, Taiwan

Location

Min-Shen General Hospital

Taoyuan District, 33044, Taiwan

Location

Related Publications (13)

• 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. doi: 10.2337/diacare.21.4.518.

  PMID: 9571335 BACKGROUND

• 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. doi: 10.1016/s0168-8227(01)00308-4.

  PMID: 11580968 BACKGROUND

• 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. doi: 10.1016/s0168-8227(01)00310-2.

  PMID: 11580970 BACKGROUND

• 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. doi: 10.1016/s0168-8227(01)00311-4.

  PMID: 11580971 BACKGROUND

• 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. doi: 10.1177/106286060001500205.

  PMID: 10763220 BACKGROUND

• 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. doi: 10.2337/diacare.23.5.682. No abstract available.

  PMID: 10834430 BACKGROUND

• 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. doi: 10.1210/jcem.83.8.5075.

  PMID: 9709924 BACKGROUND

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

  PMID: 9540446 BACKGROUND

• 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. No abstract available.

  PMID: 12017675 BACKGROUND

• American Diabetes Association. Standards of medical care for patients with diabetes mellitus. Diabetes Care. 2002 Jan;25(1):213-29. doi: 10.2337/diacare.25.1.213. No abstract available.

  PMID: 11772918 BACKGROUND

• American Diabetes Association. Screening for type 2 diabetes. Diabetes Care. 2000 Jan;23 Suppl 1:S20-3. No abstract available.

  PMID: 12017671 BACKGROUND

• Huang MC, Chang WT, Chang HY, Chung HF, Chen FP, Huang YF, Hsu CC, Hwang SJ. FADS Gene Polymorphisms, Fatty Acid Desaturase Activities, and HDL-C in Type 2 Diabetes. Int J Environ Res Public Health. 2017 May 28;14(6):572. doi: 10.3390/ijerph14060572.

  PMID: 28555039 DERIVED

• Chung HF, Long KZ, Hsu CC, Al Mamun A, Jhang HR, Shin SJ, Hwang SJ, Huang MC. Association of n-3 polyunsaturated fatty acids and inflammatory indicators with renal function decline in type 2 diabetes. Clin Nutr. 2015 Apr;34(2):229-34. doi: 10.1016/j.clnu.2014.02.009. Epub 2014 Mar 19.

  PMID: 24721145 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Chih-Cheng Hsu, M.D, Dr. P.H

  National Health Research Instiutes

  PRINCIPAL INVESTIGATOR

• Hsing-Yi Chang, Ph. Dr. P.H

  National Health Research Instiutes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 8, 2006
• Study Start: July 1, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: January 27, 2010

Record last verified: 2008-02

Locations

TW (5)