A Prospective Study on Diabetes Management Through an Integrated Delivery System (DMIDS)

This study has been completed.
Sponsor:
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00288678
First received: February 7, 2006
Last updated: January 26, 2010
Last verified: February 2008
  Purpose
  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.

Condition Intervention Phase
Diabetes Mellitus
Procedure: Health Education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Prospective Study on Diabetes Management Through an Integrated Delivery System

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 1222
Study Start Date: July 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00288678

Locations
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 80708
China Medical University Hospital
Taichung, Taiwan, 40447
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Tri-Services General Hospital
Taipei, Taiwan, 11490
Min-Shen General Hospital
Taoyuan, Taiwan, 33044
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Investigators
Principal Investigator: 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
  More Information

Additional Information:
Publications:

Responsible Party: Center for Healthy Policy Research and Development, National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT00288678     History of Changes
Other Study ID Numbers: HP-PP08
Study First Received: February 7, 2006
Last Updated: January 26, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Diabetic shared care
Health manager
Prospective Study
Health Care Quality, Access, and Evaluation

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 20, 2014