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

February 7, 2006
January 26, 2010
July 2003
December 2007   (final data collection date for primary outcome 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.
Same as current
Complete list of historical versions of study NCT00288678 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
A Prospective Study on Diabetes Management Through an Integrated Delivery System
A Prospective Study on Diabetes Management Through an Integrated Delivery System
  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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Diabetes Mellitus
Procedure: Health Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1222
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00288678
HP-PP08
No
Center for Healthy Policy Research and Development, National Health Research Institutes, Taiwan
National Health Research Institutes, Taiwan
Not Provided
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
National Health Research Institutes, Taiwan
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP