A Prospective Study on Diabetes Management Through an Integrated Delivery System

NCT ID: NCT00288678

Last Updated: 2010-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Interventions

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Health Education

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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National Health Research Institutes, Taiwan

Principal Investigators

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Chih-Cheng Hsu, M.D, Dr. P.H

Role: PRINCIPAL_INVESTIGATOR

National Health Research Instiutes

Hsing-Yi Chang, Ph. Dr. P.H

Role: PRINCIPAL_INVESTIGATOR

National Health Research Instiutes

Locations

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Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Tri-Services General Hospital

Taipei, , Taiwan

Site Status

Min-Shen General Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 9571335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11580968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11580970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11580971 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10763220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10834430 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9709924 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 9540446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12017675 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11772918 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12017671 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28555039 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24721145 (View on PubMed)

Other Identifiers

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HP-PP08

Identifier Type: -

Identifier Source: org_study_id

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