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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05394532
Other study ID # IHLin
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2020
Est. completion date December 12, 2021

Study information

Verified date June 2022
Source National Taipei University of Nursing and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Type 1 diabetes is the autoimmunity system produces the antibody which starts to attack the B lymphocytes while the autoimmunity is also been attacked. When the autoimmunity system has been destoyed, the insulin couldn't be secreted normally. thus, the hyperglycaemia is caused. Then, the patients need to rely on the insulin injection throughout the lifetime. The main symptoms are the three mores (eat more, drink more and urinate more), weight loss, urine sugar, lethargy, ketone bodies and ect. The most serious complications of the diabetes type 1 is the Diabetic ketoacidosis, DKA. It is caused by the severe infection or poor Glycemic Control. If the DKA happened, the patients need to be rescued in the ICU. is because it sometimes endager life. The diabetes type 1 patients rely on the insulin injection throughout the lifetime and a good habbit of diet, boold sugar controlling and exercise. The DKA happens when the boold sugar is not well controlled.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date December 12, 2021
Est. primary completion date December 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 18 Years
Eligibility Inclusion Criteria: - 10-18years ord Type 1 DM. - Able to read and write Chinese. Exclusion Criteria: - Communication and cognitive impairments.

Study Design


Intervention

Other:
Education
Common Education

Locations

Country Name City State
Taiwan Fangyi Lin Taipei city Beitou

Sponsors (1)

Lead Sponsor Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1c The subjects were 83 adolescents diagnosed with type 1 diabetes mellitus. The experiment group intervened with the Steno Balance Card method was better than the control group which received only general health education in terms of blood sugar control after 3 months . 3 months
Secondary self management There was in scores between the experimental and the control groups three months after intervention which means both health education methods improved the level of self-management in patients. 3 months
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