AzTrials
AzTrials

Diabetes MellitusPhase 3DMIDSNCT00288678

A Prospective Study on Diabetes Management Through an Integrated Delivery System

A Phase 3 study testing Health Education in people with Diabetes Mellitus, run by National Health Research Institutes, Taiwan at 5 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Health Education
Type of treatment
Surgery or procedure
How many people
1,222 participants
Where
5 sitesTaiwan
Study dates
Jul 2003to Dec 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Taiwan5 sites

  • Kaohsiung Medical University Hospital

    Kaohsiung City, 80708

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70403

  • Tri-Services General Hospital

    Taipei, 11490

  • Min-Shen General Hospital

    Taoyuan, 33044

Other trials in Taiwan

About this study

  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.
Read the 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.

Being tested
Health Education
Keywords
Diabetic shared care, Health manager, Prospective Study, Health Care Quality, Access, and Evaluation
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health EducationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2006 (estimated)
  2. Study startJul 2003
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00288678
Sponsor's protocol ID
HP-PP08
Acronym
DMIDS
Status last verified
Feb 2008
First submitted
7 Feb 2006
Last updated
27 Jan 2010
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 9571335

  • 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.

    PubMed 11580968

  • 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.

    PubMed 11580970

  • 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.

    PubMed 11580971

  • 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.

    PubMed 10763220

  • 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.

    PubMed 10834430

  • 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.

    PubMed 9709924

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

    PubMed 9540446

  • 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.

    PubMed 12017675

  • 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.

    PubMed 11772918

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

    PubMed 12017671

  • 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.

    PubMed 28555039

  • 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.

    PubMed 24721145

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Health Education in people with Diabetes Mellitus, run by National Health Research Institutes, Taiwan at 5 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00288678, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in