- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05394532
Steno Diabetes Dialogue Cards Teaching on Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
June 5, 2022 updated by: Lin, I-Hsiang, National Taipei University of Nursing and Health Sciences
Effect of Steno Diabetes Dialogue Cards Teaching Instrument on Diabetes in Group Education on Blood Sugar Control in Adolescents With Type 1 Diabetes
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beitou
-
Taipei city, Beitou, Taiwan, 112303
- Fangyi Lin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 10-18years ord Type 1 DM.
- Able to read and write Chinese.
Exclusion Criteria:
- Communication and cognitive impairments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Steno Diabetes Dialogue Cards
|
Common Education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 3 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self management
Time Frame: 3 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 2, 2020
Primary Completion (Actual)
December 12, 2021
Study Completion (Actual)
December 12, 2021
Study Registration Dates
First Submitted
May 24, 2022
First Submitted That Met QC Criteria
May 24, 2022
First Posted (Actual)
May 27, 2022
Study Record Updates
Last Update Posted (Actual)
June 7, 2022
Last Update Submitted That Met QC Criteria
June 5, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IHLin
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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